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Clinical Trial Results:
Improving outcomes for patients with hip osteoarthritis: a randomised controlled trial

Summary
EudraCT number	2014-003412-37
Trial protocol	GB
Global end of trial date	19 Dec 2018
Results information
Results version number	v2(current)
This version publication date	19 Jul 2020
First version publication date	04 Jan 2020
Other versions	v1
Version creation reason	Correction of full data set Overall follow up numbers are now presented as total follow up responses (previously only primary outcome completion numbers had been recorded under 'Completion' within the section on 'Number of subjects in period 1'). Within this section, the total number of subject-withdrawals has been updated. Part incorrect and excluded BMI data has been updated.

Trial information Top of page
Trial identification
Sponsor protocol code	323/12
Additional study identifiers
ISRCTN number	ISRCTN50550256
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Keele University
Sponsor organisation address	Keele, Newcastle-under-Lyme, United Kingdom, ST5 5BG
Public contact	Study co-ordinator, Keele University, 44 01782734875, a.cherrington@keele.ac.uk
Scientific contact	Study co-ordinator, Keele University, 44 01782734875, a.cherrington@keele.ac.uk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	03 Jun 2019
Is this the analysis of the primary completion data?	Yes
Primary completion date	19 Dec 2018
Global end of trial reached?	Yes
Global end of trial date	19 Dec 2018
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	The primary objective of this trial is to compare longitudinal average mean pain scores over 6 months in people with hip osteoarthritis between those receiving best current treatment in addition to a steroid and local anesthetic injection with those receiving best current treatment alone.
Protection of trial subjects	The trial was performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 52nd World Medical Association General Assembly, Edinburgh, Scotland. Informed written consent was obtained from the participants prior to any trial-specific procedures taking place. The right of a participant to refuse participation without giving reasons was respected. The trial was submitted to and approved by a main NHS Research Ethics Committee (main REC) and the appropriate site approvals given for each participating centre prior to entering participants into the trial. Subsequent amendments were approved by the Health Research Authority (HRA), main REC and MHRA as required. All information collected during the course of the trial is kept strictly confidential. Keele CTU complied with all aspects of the applicable Data Protection Act.
Background therapy	None
Evidence for comparator	Best current treatment comprised verbal and written information to enhance understanding of osteoarthritis and its management, and provide personalised advice and information about weight loss, exercise, footwear, walking aids and optimising pain management, consistent with the National Institute for Health and Care Excellence (NICE) osteoarthritis care and management clinical guideline (CG 177, published February 2014)). https://www.nice.org.uk/guidance/cg177 Triamcinolone acetonide has a well-established safety profile and was used at the dosage and form detailed in the Summary of Product Characteristics (SPC). It is licensed for use in osteoarthritis and is widely used for this purpose in clinical practice. There is one published randomised trial of an intra-articular injection of triamcinolone acetonide for hip osteoarthritis, which showed that triamcinolone acetonide 80mg produced greater reduction in pain than 1% mepivocaine (Kullenberg J Rheumatol 2004;31(11):2265–8). 1% lidocaine hydrochloride is licensed for regional anaesthesia and the dosage used in the trial is within current established practice as detailed in the Summary of Product Characteristics (SPC). There is one published randomised trial in which intra-articular injection interventions for hip osteoarthritis included 1% lidocaine hydrochloride, finding that 1ml 1% lidocaine hydrochloride plus saline water was less effective than 1ml 1% lidocaine hydrochloride in combination with a corticosteroid (methylprednisolone acetate) (Qvistgaard 2006;14(2):163–70).
Actual start date of recruitment	01 Oct 2015
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United Kingdom: 199
Worldwide total number of subjects	199
EEA total number of subjects	199
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	113
From 65 to 84 years	83
85 years and over	3

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Participants were recruited from primary care referrals to orthopaedics, rheumatology and two musculoskeletal NHS interface services, and direct from primary care.
Pre-assignment
Screening details	Potentially eligible patients were posted study information and invited to attend musculoskeletal hip clinics within two musculoskeletal interface services, where patients were screened, consented and treated.
Pre-assignment period milestones
Number of subjects started	199
Number of subjects completed	199
Period 1
Period 1 title	Trial recruitment and follow up (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Single blind
Roles blinded	Data analyst [1]
Blinding implementation details	Participants and clinicians were not blind to allocation to BCT alone, or, BCT plus injection. However, for those participants randomised to either of the two injection arms, participants and non-injecting clinicians were blind to the exact nature of the injection (triamcinolone acetonide plus 1% lidocaine hydrochloride or 1% lidocaine hydrochloride alone). The statisticians and research nurses (who conducted minimal data collection) were blind to allocation.
Arms
Are arms mutually exclusive	Yes
Arm title	Best Current Treatment
Arm description	BCT comprised written information (Arthritis Research UK Osteoarthritis leaflet and a bespoke leaflet on exercise and functional activities), personalised advice and information about weight loss, exercise, footwear, walking aids and optimising pain management, delivered within the clinic visit.
Arm type	Control arm
Investigational medicinal product name	No investigational medicinal product assigned in this arm
Arm title	BCT+US-L
Arm description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 5ml 1% lidocaine only.
Arm type	Active comparator
Investigational medicinal product name	1% lidocaine hydrochloride
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intraarticular use
Dosage and administration details	Single intra-articular injection of 5mls 1% lidocaine hydrochloride into the hip
Arm title	BCT+US-T
Arm description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride.
Arm type	Experimental
Investigational medicinal product name	Triamcinolone acetonide
Investigational medicinal product code
Other name
Pharmaceutical forms	Suspension for injection
Routes of administration	Intraarticular use
Dosage and administration details	Single intra-articular injection of 40mg triamcinolone acetonide into the hip (combined with 4mls 1% lidocaine hydrochloride)
Investigational medicinal product name	1% lidocaine hydrochloride
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intraarticular use
Dosage and administration details	Single intra-articular injection of 4mls 1% lidocaine hydrochloride into the hip (combined with 40mg triamcinolone acetonide)
Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Analysis was performed blind to treatment allocation. Subjects were blind to injection type but not whether or not they received an injection. Data collection was self reported but a blind assessor collected data from non responders.
Number of subjects in period 1 Best Current Treatment BCT+US-L BCT+US-T Started 67 66 66 Baseline 67 66 66 2 weeks follow up 62 65 65 2 months follow up 59 65 66 4 months follow up 57 63 61 6 months follow up 56 61 61 Completed 56 61 61 Not completed 11 5 5      Adverse event, serious fatal - - 2      Consent withdrawn by subject 9 3 2      Lost to follow-up 2 2 1

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Best Current Treatment
Reporting group description	BCT comprised written information (Arthritis Research UK Osteoarthritis leaflet and a bespoke leaflet on exercise and functional activities), personalised advice and information about weight loss, exercise, footwear, walking aids and optimising pain management, delivered within the clinic visit.
Reporting group title	BCT+US-L
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 5ml 1% lidocaine only.
Reporting group title	BCT+US-T
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride.
Reporting group values Best Current Treatment BCT+US-L BCT+US-T Total Number of subjects 67 66 66 199 Age categorical Units: Subjects     In utero 0 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0 0     Newborns (0-27 days) 0 0 0 0     Infants and toddlers (28 days-23 months) 0 0 0 0     Children (2-11 years) 0 0 0 0     Adolescents (12-17 years) 0 0 0 0     Adults (18-64 years) 37 39 37 113     From 65-84 years 28 26 29 83     85 years and over 2 1 0 3 Age continuous Units: years     arithmetic mean (standard deviation) 63.7 ( 10.9 ) 62.3 ( 9.8 ) 62.5 ( 9.3 ) - Gender categorical Units: Subjects     Female 42 36 35 113     Male 25 30 31 86 Centre Units: Subjects     Haywood 57 56 50 163     Cannock 10 10 16 36 Ethnic group Ethnic group question: Which group do you consider yourself to belong to? White Non-white = Black/African/Carribean/Black British or Asian/Asian British or Mixed/multiple ethnic groups or Other Units: Subjects     Non-white 0 1 0 1     White 67 65 66 198 Living alone Units: Subjects     No 57 53 57 167     Yes 10 13 9 32 Currently employed Units: Subjects     No 10 10 6 26     No, retired 30 29 23 82     Yes 25 26 37 88     Missing data 2 1 0 3 Smoking status Units: Subjects     Never 33 29 35 97     Previous 24 24 21 69     Current 10 13 10 33 Alcohol consumption Units: Subjects     Daily / most days 12 7 12 31     Once or twice a week 22 31 25 78     Once or twice a month 16 9 11 36     Once or twice a year 7 8 12 27     Never 10 11 6 27 Hip(s) affected Over the last 12 months, pain in which hip(s) Units: Subjects     Both 16 19 14 49     Right only 32 30 28 90     Left only 19 17 24 60 Duration of symptoms Over the last 12 months, how many days had pain Units: Subjects     Less than 3 months 2 1 3 6     Between 3 months and 6 months 8 4 5 17     Between 6 months and 1 year 19 14 9 42     More than 1 year 38 47 48 133     Missing data 0 0 1 1 Days of pain in last 12 months Over last 12 months, how many days in pain Units: Subjects     Less than 7 days 0 1 0 1     1-4 weeks 0 0 0 0     More than 1 month but less than 3 months 4 2 6 12     3 months or more 63 63 60 186 Previous hip injury Ever injured hip badly enough to see a doctor about it Units: Subjects     No 59 55 58 172     Right hip only 2 5 4 11     Left hip only 2 5 3 10     Both hips 3 1 1 5     Missing data 1 0 0 1 Sleep problems During past 4 weeks, troubled by pain from hip in bed at night Units: Subjects     No nights 6 2 1 9     Only 1 or 2 nights 2 5 3 10     Some nights 19 10 10 39     Most nights 19 19 24 62     Every night 21 30 28 79 Previous hip injection Ever had steroid injection(s) into hip(s)? Units: Subjects     No 64 63 65 192     Yes 3 3 1 7 Injection to other joint Ever had a steroid injection into a joint other than the hip Units: Subjects     No 48 43 40 131     Yes 19 23 25 67     Missing data 0 0 1 1 Preference Treatment preference Units: Subjects     To have a hip injection 62 61 62 185     Not to have a hip injection 5 3 3 11     Missing data 0 2 1 3 Comorbidity Other health conditions Units: Subjects     No 20 19 29 68     Yes 47 46 36 129     Missing data 0 1 1 2 BMI Body Mass Index (kg/m2) Units: kg/m2     arithmetic mean (standard deviation) 29.6 ( 6.7 ) 28.4 ( 4.9 ) 29.5 ( 5.6 ) - Pain NRS How severe is hip pain today (0-10 scale; 0=no pain at all, 10=worst pain imaginable) Units: 0-10 scale     arithmetic mean (standard deviation) 5.7 ( 2.2 ) 5.7 ( 2.1 ) 5.8 ( 2.1 ) - WOMAC - Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Total scale score (0-96 scale; 0=no prolems; 96=extreme problems) Units: 0-96 scale     arithmetic mean (standard deviation) 51.1 ( 19.0 ) 50.7 ( 13.0 ) 50.2 ( 14.8 ) - WOMAC-P Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Pain subscale score (0-20 scale; 0=no pain, 20=extreme pain) Units: 0-20 scale     arithmetic mean (standard deviation) 10.7 ( 4.0 ) 10.7 ( 3.2 ) 10.7 ( 2.8 ) - WOMAC-S Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Stiffness subscale score (0-8 scale; 0=no stiffness, 8=extreme stiffness) Units: 0-8 scale     arithmetic mean (standard deviation) 4.3 ( 1.5 ) 4.6 ( 1.5 ) 4.6 ( 1.4 ) - WOMAC-F Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Function subscale (0-68; 0=no difficulty; 68=extreme difficulty) Units: 0-68 scale     arithmetic mean (standard deviation) 36.0 ( 14.6 ) 35.4 ( 10.9 ) 35.0 ( 11.6 ) - PSEQ Pain Self-Efficacy Questionnaire (0-60 scale; 0=no confidence; 60=highest confidence) Units: 0-60 scale     arithmetic mean (standard deviation) 35.7 ( 14.7 ) 38.5 ( 13.0 ) 36.4 ( 13.4 ) - IPQ modified brief Illness Perceptions Questionnaire (0-50 scale; 0=full understanding, 50=least understanding) Units: 0-50 scale     arithmetic mean (standard deviation) 30.7 ( 7.2 ) 29.9 ( 5.4 ) 29.8 ( 7.3 ) - IPQ-Consequences modified brief Illness Perceptions Questionnaire - Consequences subscale (0-10 scale; 0=no affect at all; 10=severely affects life) Units: 0-10 scale     arithmetic mean (standard deviation) 6.5 ( 2.4 ) 6.5 ( 1.8 ) 6.4 ( 2.1 ) - IPQ-Timeline modified brief Illness Perceptions Questionnaire - Timeline subscale (0-10 scale; 0=last very short time; 10=last forever) Units: 0-10 scale     arithmetic mean (standard deviation) 9.0 ( 1.4 ) 9.2 ( 1.3 ) 8.7 ( 1.8 ) - IPQ-Personal control modified brief Illness Perceptions Questionnaire - Personal control subscale (0-10 scale; 0=no control; 10=extreme control) Units: 0-10 scale     arithmetic mean (standard deviation) 3.6 ( 2.8 ) 4.1 ( 2.9 ) 4.2 ( 2.6 ) - IPQ-Treatment control modified brief Illness Perceptions Questionnaire - Treatment control subscale (0-10 scale; 0=treatment no help; 10=treatment extremely helpful) Units: 0-10 scale     arithmetic mean (standard deviation) 7.4 ( 2.0 ) 7.4 ( 2.0 ) 7.3 ( 2.0 ) - IPQ-Emotional response modified brief Illness Perceptions Questionnaire - Emotional response subscale (0-10 scale; 0=not affected emotionally; 10=extremely affected emotionally) Units: 0-10 scale     arithmetic mean (standard deviation) 6.1 ( 2.9 ) 5.7 ( 2.8 ) 6.1 ( 2.7 ) - EQ5D EuroQoL EQ5D (health utilit) (-0.59 to 1.00; [-0.59=worst health utility, 1.00=best health utility) Units: -0.59 to 1.00     arithmetic mean (standard deviation) 0.50 ( 0.22 ) 0.48 ( 0.24 ) 0.49 ( 0.23 ) - SF-12 PCS Short Form-12 Physical Component Scale (SF12_PCS) (0-100 scale; 0=worst physical health, 100=best physical health) Units: 0-100     arithmetic mean (standard deviation) 33.9 ( 9.1 ) 33.2 ( 8.9 ) 34.5 ( 9.0 ) - SF12-MCS Short Form-12 Mental Component Scale (SF12_MCS) (0-100 scale; 0=worst mental health, 100=best mental health) Units: 0-100 scale     arithmetic mean (standard deviation) 49.3 ( 13.3 ) 52.9 ( 10.0 ) 51.5 ( 12.2 ) - GAD-7 Generalised Anxiety Disorder Assessment (7-item scale) Units: 0-21 scale     arithmetic mean (standard deviation) 6.1 ( 6.3 ) 5.3 ( 5.8 ) 5.9 ( 5.9 ) - PHQ-8 Patient Health Questionnaire depression scale Units: 0-24 scale     arithmetic mean (standard deviation) 6.9 ( 6.2 ) 6.2 ( 6.0 ) 6.7 ( 6.2 ) - SPS Stanford Presenteeism Scale (6-30 scale; 6=minimum ability, 30=maximum ability) Units: score     arithmetic mean (standard deviation) 20.0 ( 6.1 ) 20.2 ( 3.7 ) 20.2 ( 4.7 ) - Work Performance Work Performance (Numerical Rating Scale (NRS), 0-10; 0=Not at all affected, 10=Pain so bad that unable to do job). Question worded: On average to what extent has your hip problem affected your performance at work in the last 6 weeks? Units: score     arithmetic mean (standard deviation) 3.9 ( 3.3 ) 5.2 ( 2.8 ) 4.7 ( 2.4 ) -
Subject analysis sets
Subject analysis set title	Primary endpoint
Subject analysis set type	Intention-to-treat
Subject analysis set description	Primary endpoint = average NRS-pain score over 2 weeks, 2 months, 4 months and 6 months follow up
Subject analysis sets values Primary endpoint Number of subjects 194 Age categorical Units: Subjects     In utero 0     Preterm newborn infants (gestational age < 37 wks) 0     Newborns (0-27 days) 0     Infants and toddlers (28 days-23 months) 0     Children (2-11 years) 0     Adolescents (12-17 years) 0     Adults (18-64 years) 109     From 65-84 years 82     85 years and over 3 Age continuous Units: years     arithmetic mean (standard deviation) 63.0 ( 9.8 ) Gender categorical Units: Subjects     Female 110     Male 84 Centre Units: Subjects     Haywood 159     Cannock 35 Ethnic group Ethnic group question: Which group do you consider yourself to belong to? White Non-white = Black/African/Carribean/Black British or Asian/Asian British or Mixed/multiple ethnic groups or Other Units: Subjects     Non-white 1     White 193 Living alone Units: Subjects     No 164     Yes 30 Currently employed Units: Subjects     No 25     No, retired 81     Yes 85     Missing data 3 Smoking status Units: Subjects     Never 95     Previous 67     Current 32 Alcohol consumption Units: Subjects     Daily / most days 31     Once or twice a week 77     Once or twice a month 35     Once or twice a year 24     Never 27 Hip(s) affected Over the last 12 months, pain in which hip(s) Units: Subjects     Both 48     Right only 88     Left only 58 Duration of symptoms Over the last 12 months, how many days had pain Units: Subjects     Less than 3 months 6     Between 3 months and 6 months 16     Between 6 months and 1 year 41     More than 1 year 130     Missing data 1 Days of pain in last 12 months Over last 12 months, how many days in pain Units: Subjects     Less than 7 days 1     1-4 weeks 0     More than 1 month but less than 3 months 12     3 months or more 181 Previous hip injury Ever injured hip badly enough to see a doctor about it Units: Subjects     No 169     Right hip only 10     Left hip only 10     Both hips 5     Missing data 0 Sleep problems During past 4 weeks, troubled by pain from hip in bed at night Units: Subjects     No nights 9     Only 1 or 2 nights 10     Some nights 38     Most nights 61     Every night 76 Previous hip injection Ever had steroid injection(s) into hip(s)? Units: Subjects     No 187     Yes 7 Injection to other joint Ever had a steroid injection into a joint other than the hip Units: Subjects     No 128     Yes 65     Missing data 1 Preference Treatment preference Units: Subjects     To have a hip injection 180     Not to have a hip injection 11     Missing data 3 Comorbidity Other health conditions Units: Subjects     No 67     Yes 125     Missing data 2 BMI Body Mass Index (kg/m2) Units: kg/m2     arithmetic mean (standard deviation) 29.2 ( 5.7 ) Pain NRS How severe is hip pain today (0-10 scale; 0=no pain at all, 10=worst pain imaginable) Units: 0-10 scale     arithmetic mean (standard deviation) 5.7 ( 2.1 ) WOMAC - Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Total scale score (0-96 scale; 0=no prolems; 96=extreme problems) Units: 0-96 scale     arithmetic mean (standard deviation) 50.8 ( 16.0 ) WOMAC-P Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Pain subscale score (0-20 scale; 0=no pain, 20=extreme pain) Units: 0-20 scale     arithmetic mean (standard deviation) 10.7 ( 3.3 ) WOMAC-S Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Stiffness subscale score (0-8 scale; 0=no stiffness, 8=extreme stiffness) Units: 0-8 scale     arithmetic mean (standard deviation) 4.5 ( 1.5 ) WOMAC-F Western Ontario and McMaster Universities Arthritis Index (WOMAC) - Function subscale (0-68; 0=no difficulty; 68=extreme difficulty) Units: 0-68 scale     arithmetic mean (standard deviation) 35.6 ( 12.3 ) PSEQ Pain Self-Efficacy Questionnaire (0-60 scale; 0=no confidence; 60=highest confidence) Units: 0-60 scale     arithmetic mean (standard deviation) 37.1 ( 13.7 ) IPQ modified brief Illness Perceptions Questionnaire (0-50 scale; 0=full understanding, 50=least understanding) Units: 0-50 scale     arithmetic mean (standard deviation) 30.0 ( 6.7 ) IPQ-Consequences modified brief Illness Perceptions Questionnaire - Consequences subscale (0-10 scale; 0=no affect at all; 10=severely affects life) Units: 0-10 scale     arithmetic mean (standard deviation) 6.5 ( 2.1 ) IPQ-Timeline modified brief Illness Perceptions Questionnaire - Timeline subscale (0-10 scale; 0=last very short time; 10=last forever) Units: 0-10 scale     arithmetic mean (standard deviation) 9.0 ( 1.5 ) IPQ-Personal control modified brief Illness Perceptions Questionnaire - Personal control subscale (0-10 scale; 0=no control; 10=extreme control) Units: 0-10 scale     arithmetic mean (standard deviation) 4.0 ( 2.8 ) IPQ-Treatment control modified brief Illness Perceptions Questionnaire - Treatment control subscale (0-10 scale; 0=treatment no help; 10=treatment extremely helpful) Units: 0-10 scale     arithmetic mean (standard deviation) 7.4 ( 2.0 ) IPQ-Emotional response modified brief Illness Perceptions Questionnaire - Emotional response subscale (0-10 scale; 0=not affected emotionally; 10=extremely affected emotionally) Units: 0-10 scale     arithmetic mean (standard deviation) 5.9 ( 2.8 ) EQ5D EuroQoL EQ5D (health utilit) (-0.59 to 1.00; [-0.59=worst health utility, 1.00=best health utility) Units: -0.59 to 1.00     arithmetic mean (standard deviation) 0.49 ( 0.23 ) SF-12 PCS Short Form-12 Physical Component Scale (SF12_PCS) (0-100 scale; 0=worst physical health, 100=best physical health) Units: 0-100     arithmetic mean (standard deviation) 34.0 ( 8.8 ) SF12-MCS Short Form-12 Mental Component Scale (SF12_MCS) (0-100 scale; 0=worst mental health, 100=best mental health) Units: 0-100 scale     arithmetic mean (standard deviation) 51.3 ( 11.8 ) GAD-7 Generalised Anxiety Disorder Assessment (7-item scale) Units: 0-21 scale     arithmetic mean (standard deviation) 5.7 ( 5.9 ) PHQ-8 Patient Health Questionnaire depression scale Units: 0-24 scale     arithmetic mean (standard deviation) 6.6 ( 6.0 ) SPS Stanford Presenteeism Scale (6-30 scale; 6=minimum ability, 30=maximum ability) Units: score     arithmetic mean (standard deviation) 20.2 ( 4.9 ) Work Performance Work Performance (Numerical Rating Scale (NRS), 0-10; 0=Not at all affected, 10=Pain so bad that unable to do job). Question worded: On average to what extent has your hip problem affected your performance at work in the last 6 weeks? Units: score     arithmetic mean (standard deviation) 4.6 ( 2.8 )

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Best Current Treatment
Reporting group description	BCT comprised written information (Arthritis Research UK Osteoarthritis leaflet and a bespoke leaflet on exercise and functional activities), personalised advice and information about weight loss, exercise, footwear, walking aids and optimising pain management, delivered within the clinic visit.
Reporting group title	BCT+US-L
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 5ml 1% lidocaine only.
Reporting group title	BCT+US-T
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride.
Subject analysis set title	Primary endpoint
Subject analysis set type	Intention-to-treat
Subject analysis set description	Primary endpoint = average NRS-pain score over 2 weeks, 2 months, 4 months and 6 months follow up

End points Top of page

Primary: Pain score at 2 weeks Top of page
End point title	Pain score at 2 weeks
End point description	Comparison of pain scores at 2 weeks follow up (0-10 pain scale; 0=no pain, 10=maximum pain)
End point type	Primary
End point timeframe	2 weeks
End point values Best Current Treatment BCT+US-L BCT+US-T Primary endpoint Number of subjects analysed 62 63 64 189 Units: score     arithmetic mean (standard deviation) 6.0 ( 2.3 ) 4.0 ( 2.4 ) 3.0 ( 2.5 ) 4.3 ( 2.7 )
Statistical analysis title	Pain score (2 weeks) - BCT+US-T versus BCT
Statistical analysis description	Pain score at 2 weeks follow up (BCT+US-T minus BCT) adjusted for age, gender and baseline pain score
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-3.17
Confidence interval
level	95%
sides	2-sided
lower limit	-4.06
upper limit	-2.28
Variability estimate	Standard error of the mean
Statistical analysis title	Pain score (2 weeks) - BCT+US-T versus BCT+US-L
Statistical analysis description	Pain score at 2 weeks follow up (BCT+US-T minus BCT+US-L) adjusted for age, gender and baseline pain score
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	127
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.023
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.02
Confidence interval
level	95%
sides	2-sided
lower limit	-1.9
upper limit	-0.14
Variability estimate	Standard error of the mean

Primary: Pain score at 2 weeks Top of page

Primary: Pain score at 2 months Top of page
End point title	Pain score at 2 months
End point description	Pain score at 2 months follow up
End point type	Primary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Primary endpoint Number of subjects analysed 58 65 64 187 Units: score     arithmetic mean (standard deviation) 5.8 ( 2.5 ) 4.7 ( 2.6 ) 4.2 ( 2.8 ) 4.9 ( 2.7 )
Statistical analysis title	Pain score (2 months) - BCT+US-T versus BCT
Statistical analysis description	Pain score at 2 monthsfollow up (BCT+US-T minus BCT) adjusted for age, gender and baseline pain score
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.81
Confidence interval
level	95%
sides	2-sided
lower limit	-2.71
upper limit	-0.92
Variability estimate	Standard error of the mean
Statistical analysis title	Pain score (2 months) - BCT+US-T versus BCT+US-L
Statistical analysis description	Pain score at 2 months follow up (BCT+US-T minus BCT+US-L) adjusted for age, gender and baseline pain score
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.136
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.67
Confidence interval
level	95%
sides	2-sided
lower limit	-1.54
upper limit	0.21
Variability estimate	Standard error of the mean

Primary: Pain score at 2 months Top of page

Primary: Pain score at 4 months Top of page
End point title	Pain score at 4 months
End point description	Pain score at 4 months follow up
End point type	Primary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Primary endpoint Number of subjects analysed 57 63 59 179 Units: score     arithmetic mean (standard deviation) 5.4 ( 2.9 ) 5.0 ( 2.6 ) 4.5 ( 2.7 ) 4.9 ( 2.7 )
Statistical analysis title	Pain score (4 months) - BCT+US-T versus BCT
Statistical analysis description	Pain score at 4 months follow up (BCT+US-T minus BCT) adjusted for age, gender and baseline pain score
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.063
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.86
Confidence interval
level	95%
sides	2-sided
lower limit	-1.78
upper limit	0.05
Variability estimate	Standard error of the mean
Statistical analysis title	Pain score (4 months) - BCT+US-T versus BCT+US-L
Statistical analysis description	Pain score at 4 months follow up (BCT+US-T minus BCT+US-L) adjusted for age, gender and baseline pain score
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.291
Method	Mixed models analysis
Parameter type	Mean difference (net)
Point estimate	-0.48
Confidence interval
level	95%
sides	2-sided
lower limit	-1.37
upper limit	0.41
Variability estimate	Standard error of the mean

Primary: Pain score at 4 months Top of page

Primary: Pain score at 6 months Top of page
End point title	Pain score at 6 months
End point description
End point type	Primary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Primary endpoint Number of subjects analysed 56 61 61 178 Units: score     arithmetic mean (standard deviation) 5.0 ( 2.8 ) 5.0 ( 2.5 ) 5.1 ( 2.7 ) 5.1 ( 2.7 )
Statistical analysis title	Pain score (6 months) - BCT+US-T versus BCT
Statistical analysis description	Pain score at 6 months follow up (BCT+US-T minus BCT) adjusted for age, gender and baseline pain score
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.797
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.12
Confidence interval
level	95%
sides	2-sided
lower limit	-0.8
upper limit	1.04
Variability estimate	Standard error of the mean
Statistical analysis title	Pain score (6 months) - BCT+US-T versus BCT+US-L
Statistical analysis description	Pain score at 6 months follow up (BCT+US-T minus BCT+US-L) adjusted for age, gender and baseline pain score
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.823
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.1
Confidence interval
level	95%
sides	2-sided
lower limit	-0.79
upper limit	1
Variability estimate	Standard error of the mean

Primary: Pain score at 6 months Top of page

Primary: Pain score - overall, primary endpoint Top of page
End point title	Pain score - overall, primary endpoint
End point description	Primary endpoint (based on all follow up pain scores)
End point type	Primary
End point timeframe	Overall (all follow up scores: 2 weeks, 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Primary endpoint Number of subjects analysed 63 65 66 733 Units: score     arithmetic mean (standard deviation) 5.6 ( 2.7 ) 4.7 ( 2.6 ) 4.2 ( 2.8 ) 4.8 ( 2.7 )
Statistical analysis title	Pain score (overall) - BCT+US-T versus BCT
Statistical analysis description	Pain score for all available follow up data [primary endpoint] - BCT+US-T minus BCT (adjusted for age, gender and baseline pain score)
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.43
Confidence interval
level	95%
sides	2-sided
lower limit	-2.15
upper limit	-0.72
Variability estimate	Standard error of the mean
Statistical analysis title	Pain score (overall) - BCT+US-T versus BCT+US-L
Statistical analysis description	Pain score for all available follow up data [primary endpoint] BCT+US-T minus BCT+US-L (adjusted for age, gender and baseline pain score)
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	131
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.148
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.52
Confidence interval
level	95%
sides	2-sided
lower limit	-1.21
upper limit	0.18
Variability estimate	Standard error of the mean

Primary: Pain score - overall, primary endpoint Top of page

Secondary: WOMAC-Total at 2 months Top of page
End point title	WOMAC-Total at 2 months
End point description	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-Total) 0-96 [0=Minimum problems, 96=maximum problems]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 62 61 Units: score     arithmetic mean (standard deviation) 50.3 ( 21.1 ) 41.4 ( 19.2 ) 34.2 ( 20.3 )
Statistical analysis title	WOMAC-Total at 2 months
Statistical analysis description	WOMAC-Total at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-14.8
Confidence interval
level	95%
sides	2-sided
lower limit	-20.9
upper limit	-8.64
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC-Total at 2 months
Statistical analysis description	WOMAC-Total at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	123
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.027
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-6.68
Confidence interval
level	95%
sides	2-sided
lower limit	-12.6
upper limit	-0.76
Variability estimate	Standard error of the mean

Secondary: WOMAC-Total at 2 months Top of page

Secondary: WOMAC-Total at 4 months Top of page
End point title	WOMAC-Total at 4 months
End point description	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-Total) 0-96 [0=Minimum problems, 96=maximum problems]
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 56 59 Units: score     arithmetic mean (standard deviation) 43.6 ( 23.1 ) 43.9 ( 18.5 ) 38.3 ( 20.7 )
Statistical analysis title	WOMAC-Total at 4 months
Statistical analysis description	WOMAC-Total at 4 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	110
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.043
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-6.38
Confidence interval
level	95%
sides	2-sided
lower limit	-12.5
upper limit	-0.21
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC-Total at 4 months
Statistical analysis description	WOMAC-Total at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	115
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.035
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-6.42
Confidence interval
level	95%
sides	2-sided
lower limit	-12.4
upper limit	-0.45
Variability estimate	Standard error of the mean

Secondary: WOMAC-Total at 4 months Top of page

Secondary: WOMAC-Total at 6 months Top of page
End point title	WOMAC-Total at 6 months
End point description	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-Total) 0-96 [0=Minimum problems, 96=maximum problems]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 55 Units: score     arithmetic mean (standard deviation) 42.9 ( 22.6 ) 44.0 ( 19.4 ) 41.8 ( 20.8 )
Statistical analysis title	WOMAC-Total at 6 months
Statistical analysis description	WOMAC-Total at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	108
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.657
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.42
Confidence interval
level	95%
sides	2-sided
lower limit	-7.68
upper limit	4.84
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC-Total (6 months) - BCT+US-T versus BCT+US-L
Statistical analysis description	WOMAC-Total at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC-Total
Comparison groups	BCT+US-T v BCT+US-L
Number of subjects included in analysis	114
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.801
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.78
Confidence interval
level	95%
sides	2-sided
lower limit	-6.82
upper limit	5.27
Variability estimate	Standard error of the mean

Secondary: WOMAC-Total at 6 months Top of page

Secondary: WOMAC-Total - Overall Top of page
End point title	WOMAC-Total - Overall
End point description	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-Total) 0-96 [0=Minimum problems, 96=maximum problems]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 60 65 64 Units: score     arithmetic mean (standard deviation) 45.7 ( 22.4 ) 43.0 ( 19.0 ) 38.0 ( 20.7 )
Statistical analysis title	WOMAC-Total - Overall
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.007
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-7.52
Confidence interval
level	95%
sides	2-sided
lower limit	-13
upper limit	-2.04
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC-Total - Overall
Comparison groups	BCT+US-T v BCT+US-L
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.087
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-4.62
Confidence interval
level	95%
sides	2-sided
lower limit	-9.91
upper limit	0.67
Variability estimate	Standard error of the mean

Secondary: WOMAC-Total - Overall Top of page

Secondary: PSEQ at 2 months Top of page
End point title	PSEQ at 2 months
End point description	Pain Self-Efficacy Questionnaire (PSEQ), 0-60 [0=No confidence; 60=Highest confidence]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 63 62 Units: score     arithmetic mean (standard deviation) 34.3 ( 15.9 ) 39.2 ( 13.6 ) 44.4 ( 14.2 )
Statistical analysis title	PSEQ at 2 months
Statistical analysis description	PSEQ at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	9.27
Confidence interval
level	95%
sides	2-sided
lower limit	5.1
upper limit	13.4
Variability estimate	Standard error of the mean
Statistical analysis title	PSEQ at 2 months
Statistical analysis description	PSEQ at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.003
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	6.18
Confidence interval
level	95%
sides	2-sided
lower limit	2.15
upper limit	10.2
Variability estimate	Standard error of the mean

Secondary: PSEQ at 2 months Top of page

Secondary: PSEQ at 4 months Top of page
End point title	PSEQ at 4 months
End point description	Pain Self-Efficacy Questionnaire (PSEQ), 0-60 [0=No confidence; 60=Highest confidence]
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 59 60 Units: score     arithmetic mean (standard deviation) 35.2 ( 16.7 ) 37.9 ( 13.2 ) 41.2 ( 15.0 )
Statistical analysis title	PSEQ at 4 months
Statistical analysis description	PSEQ at 4 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	112
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.002
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	6.71
Confidence interval
level	95%
sides	2-sided
lower limit	2.51
upper limit	10.9
Variability estimate	Standard error of the mean
Statistical analysis title	PSEQ at 4 months
Statistical analysis description	PSEQ at 4 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.011
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	5.27
Confidence interval
level	95%
sides	2-sided
lower limit	1.21
upper limit	9.34
Variability estimate	Standard error of the mean

Secondary: PSEQ at 4 months Top of page

Secondary: PSEQ at 6 months Top of page
End point title	PSEQ at 6 months
End point description	Pain Self-Efficacy Questionnaire (PSEQ), 0-60 [0=No confidence; 60=Highest confidence]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 58 Units: score     arithmetic mean (standard deviation) 37.8 ( 14.7 ) 36.9 ( 12.8 ) 38.8 ( 15.1 )
Statistical analysis title	PSEQ at 6 months
Statistical analysis description	PSEQ at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.452
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	1.64
Confidence interval
level	95%
sides	2-sided
lower limit	-2.62
upper limit	5.9
Variability estimate	Standard error of the mean
Statistical analysis title	PSEQ at 6 months
Statistical analysis description	PSEQ at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.171
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.88
Confidence interval
level	95%
sides	2-sided
lower limit	-1.24
upper limit	7
Variability estimate	Standard error of the mean

Secondary: PSEQ at 6 months Top of page

Secondary: PSEQ - Overall Top of page
End point title	PSEQ - Overall
End point description	Pain Self-Efficacy Questionnaire (PSEQ), 0-60 [0=No confidence; 60=Highest confidence]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 60 65 65 Units: score     arithmetic mean (standard deviation) 35.7 ( 15.7 ) 38.0 ( 13.2 ) 41.5 ( 14.9 )
Statistical analysis title	PSEQ - Overall
Statistical analysis description	PSEQ overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	5.87
Confidence interval
level	95%
sides	2-sided
lower limit	2.3
upper limit	9.45
Variability estimate	Standard error of the mean
Statistical analysis title	PSEQ - Overall
Statistical analysis description	PSEQ at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline PSEQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.007
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	4.78
Confidence interval
level	95%
sides	2-sided
lower limit	1.32
upper limit	8.23
Variability estimate	Standard error of the mean

Secondary: PSEQ - Overall Top of page

Secondary: IPQ at 2 months Top of page
End point title	IPQ at 2 months
End point description	modified brief Illness Perceptions Questionnaire (IPQ), 0-50 [0=Full understanding, 50=Least understanding]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 60 60 Units: score     arithmetic mean (standard deviation) 33.0 ( 9.2 ) 30.0 ( 8.6 ) 27.2 ( 10.6 )
Statistical analysis title	IPQ at 2 months
Statistical analysis description	IPQ at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.003
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-6.04
Confidence interval
level	95%
sides	2-sided
lower limit	-9.23
upper limit	-2.84
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ at 2 months
Statistical analysis description	IPQ at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	120
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.073
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-2.55
Confidence interval
level	95%
sides	2-sided
lower limit	-5.59
upper limit	0.48
Variability estimate	Standard error of the mean

Secondary: IPQ at 2 months Top of page

Secondary: IPQ at 6 months Top of page
End point title	IPQ at 6 months
End point description	modified brief Illness Perceptions Questionnaire (IPQ), 0-50 [0=Full understanding, 50=Least understanding]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 49 58 53 Units: score     arithmetic mean (standard deviation) 30.1 ( 9.2 ) 29.2 ( 9.5 ) 30.0 ( 9.0 )
Statistical analysis title	IPQ at 6 months
Statistical analysis description	IPQ at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	102
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.701
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.15
Confidence interval
level	95%
sides	2-sided
lower limit	-3.44
upper limit	3.14
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ at 6 months
Statistical analysis description	IPQ at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.912
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.79
Confidence interval
level	95%
sides	2-sided
lower limit	-2.33
upper limit	3.91
Variability estimate	Standard error of the mean

Secondary: IPQ at 6 months Top of page

Secondary: IPQ - Overall Top of page
End point title	IPQ - Overall
End point description	modified brief Illness Perceptions Questionnaire (IPQ), 0-50 [0=Full understanding, 50=Least understanding]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 58 65 63 Units: score     arithmetic mean (standard deviation) 31.6 ( 9.27 ) 29.6 ( 9.04 ) 28.5 ( 9.94 )
Statistical analysis title	IPQ - Overall
Statistical analysis description	IPQ overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	121
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.032
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-3.1
Confidence interval
level	95%
sides	2-sided
lower limit	-5.92
upper limit	-0.27
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ - Overall
Statistical analysis description	IPQ overall (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	128
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.326
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.88
Confidence interval
level	95%
sides	2-sided
lower limit	-3.57
upper limit	1.8
Variability estimate	Standard error of the mean

Secondary: IPQ - Overall Top of page

Secondary: SF-PCS at 2 months Top of page
End point title	SF-PCS at 2 months
End point description	Short Form-12 Physical Component Scale (SF12-PCS) 0-100 [0=Worst physical health, 100=Best physical health]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 60 59 Units: score     arithmetic mean (standard deviation) 32.8 ( 8.0 ) 35.0 ( 9.5 ) 39.1 ( 9.8 )
Statistical analysis title	SF_PCS at 2 months
Statistical analysis description	SF_PCS at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	114
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	5.3
Confidence interval
level	95%
sides	2-sided
lower limit	2.38
upper limit	8.21
Variability estimate	Standard error of the mean
Statistical analysis title	SF-PCS at 2 months
Statistical analysis description	SF_PCS at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.005
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	4.05
Confidence interval
level	95%
sides	2-sided
lower limit	1.2
upper limit	6.89
Variability estimate	Standard error of the mean

Secondary: SF-PCS at 2 months Top of page

Secondary: SF-PCS at 4 months Top of page
End point title	SF-PCS at 4 months
End point description	Short Form-12 Physical Component Scale (SF12-PCS) 0-100 [0=Worst physical health, 100=Best physical health]
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 53 58 Units: score     arithmetic mean (standard deviation) 35.7 ( 10.8 ) 33.7 ( 9.7 ) 39.0 ( 10.6 )
Statistical analysis title	SF-PCS at 4 months
Statistical analysis description	SF_PCS at 4 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.041
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.07
Confidence interval
level	95%
sides	2-sided
lower limit	0.13
upper limit	6.01
Variability estimate	Standard error of the mean
Statistical analysis title	SF-PCS at 4 months
Statistical analysis description	SF_PCS at 4 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	5.31
Confidence interval
level	95%
sides	2-sided
lower limit	2.41
upper limit	8.21
Variability estimate	Standard error of the mean

Secondary: SF-PCS at 4 months Top of page

Secondary: SF-PCS at 6 months Top of page
End point title	SF-PCS at 6 months
End point description	Short Form-12 Physical Component Scale (SF12-PCS) 0-100 [0=Worst physical health, 100=Best physical health]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 50 54 51 Units: score     arithmetic mean (standard deviation) 33.7 ( 9.9 ) 34.0 ( 9.5 ) 37.7 ( 10.1 )
Statistical analysis title	SF-PCS at 6 months
Statistical analysis description	SF_PCS at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	101
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.05
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.04
Confidence interval
level	95%
sides	2-sided
lower limit	0
upper limit	6.08
Variability estimate	Standard error of the mean
Statistical analysis title	SF-PCS at 6 months
Statistical analysis description	SF_PCS at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	105
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.155
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.15
Confidence interval
level	95%
sides	2-sided
lower limit	-0.81
upper limit	5.11
Variability estimate	Standard error of the mean

Secondary: SF-PCS at 6 months Top of page

Secondary: SF-PCS - Overall Top of page
End point title	SF-PCS - Overall
End point description	Short Form-12 Physical Component Scale (SF12-PCS) 0-100 [0=Worst physical health, 100=Best physical health]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 60 64 64 Units: score     arithmetic mean (standard deviation) 34.1 ( 9.6 ) 34.2 ( 9.6 ) 38.7 ( 10.1 )
Statistical analysis title	SF-PCS - Overall
Statistical analysis description	SF_PCS overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.003
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.8
Confidence interval
level	95%
sides	2-sided
lower limit	1.33
upper limit	6.27
Variability estimate	Standard error of the mean
Statistical analysis title	SF-PCS - Overall
Statistical analysis description	SF_PCS at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_PCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	128
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.002
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.84
Confidence interval
level	95%
sides	2-sided
lower limit	1.43
upper limit	6.24
Variability estimate	Standard error of the mean

Secondary: SF-PCS - Overall Top of page

Secondary: SF-MCS at 2 months Top of page
End point title	SF-MCS at 2 months
End point description	Short Form-12 Mental Component Scale (SF12-MCS) 0-100 [0=Worst mental health, 100=Best mental health]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 60 59 Units: score     arithmetic mean (standard deviation) 47.5 ( 12.9 ) 50.1 ( 12.3 ) 50.2 ( 12.0 )
Statistical analysis title	SF-MCS at 2 months
Statistical analysis description	SF_MCS at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	114
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.572
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	1.09
Confidence interval
level	95%
sides	2-sided
lower limit	-2.69
upper limit	4.87
Variability estimate	Standard error of the mean
Statistical analysis title	SF-MCS at 2 months
Statistical analysis description	SF_MCS at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.575
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.05
Confidence interval
level	95%
sides	2-sided
lower limit	-4.73
upper limit	2.63
Variability estimate	Standard error of the mean

Secondary: SF-MCS at 2 months Top of page

Secondary: SF-MCS at 4 months Top of page
End point title	SF-MCS at 4 months
End point description	Short Form-12 Mental Component Scale (SF12-MCS) 0-100 [0=Worst mental health, 100=Best mental health]
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 53 58 Units: score     arithmetic mean (standard deviation) 46.3 ( 13.5 ) 49.9 ( 11.8 ) 49.4 ( 12.4 )
Statistical analysis title	SF-MCS at 4 months
Statistical analysis description	SF_MCS at 4 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.301
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.01
Confidence interval
level	95%
sides	2-sided
lower limit	-1.8
upper limit	5.83
Variability estimate	Standard error of the mean
Statistical analysis title	SF-MCS at 4 months
Statistical analysis description	SF_MCS at 4 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.865
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.33
Confidence interval
level	95%
sides	2-sided
lower limit	-3.44
upper limit	4.1
Variability estimate	Standard error of the mean

Secondary: SF-MCS at 4 months Top of page

Secondary: SF-MCS at 6 months Top of page
End point title	SF-MCS at 6 months
End point description	Short Form-12 Mental Component Scale (SF12-MCS) 0-100 [0=Worst mental health, 100=Best mental health]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 50 54 51 Units: score     arithmetic mean (standard deviation) 49.8 ( 12.7 ) 49.2 ( 12.2 ) 48.7 ( 11.9 )
Statistical analysis title	SF-MCS at 6 months
Statistical analysis description	SF_MCS at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	101
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.195
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-2.63
Confidence interval
level	95%
sides	2-sided
lower limit	-6.61
upper limit	1.35
Variability estimate	Standard error of the mean
Statistical analysis title	SF-MCS at 6 months
Statistical analysis description	SF_MCS at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	105
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.8
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.5
Confidence interval
level	95%
sides	2-sided
lower limit	-4.37
upper limit	3.37
Variability estimate	Standard error of the mean

Secondary: SF-MCS at 6 months Top of page

Secondary: SF-MCS - Overall Top of page
End point title	SF-MCS - Overall
End point description	Short Form-12 Mental Component Scale (SF12-MCS) 0-100 [0=Worst mental health, 100=Best mental health]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 60 64 64 Units: score     arithmetic mean (standard deviation) 47.8 ( 13.0 ) 49.8 ( 12.0 ) 49.5 ( 12.0 )
Statistical analysis title	SF-MCS - Overall
Statistical analysis description	SF_MCS overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.918
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.16
Confidence interval
level	95%
sides	2-sided
lower limit	-2.83
upper limit	3.15
Variability estimate	Standard error of the mean
Statistical analysis title	SF-MCS - Overall
Statistical analysis description	SF_MCS overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SF_MCS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	128
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.843
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.29
Confidence interval
level	95%
sides	2-sided
lower limit	-2.6
upper limit	3.19
Variability estimate	Standard error of the mean

Secondary: SF-MCS - Overall Top of page

Secondary: EQ5D at 2 weeks Top of page
End point title	EQ5D at 2 weeks
End point description	EuroQol EQ5D (utility) -0.59 – 1.00 [-0.59=Worst health utility, 1.00=Best health utility]
End point type	Secondary
End point timeframe	2 weeks
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 61 64 63 Units: score     arithmetic mean (standard deviation) 0.47 ( 0.27 ) 0.59 ( 0.22 ) 0.64 ( 0.23 )
Statistical analysis title	EQ5D at 2 weeks
Statistical analysis description	EQ5D at 2 weeks (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.18
Confidence interval
level	95%
sides	2-sided
lower limit	0.12
upper limit	0.24
Variability estimate	Standard error of the mean
Statistical analysis title	EQ5D at 2 weeks
Statistical analysis description	EQ5D at 2 weeks (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	127
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.053
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.06
Confidence interval
level	95%
sides	2-sided
lower limit	0
upper limit	0.12
Variability estimate	Standard error of the mean

Secondary: EQ5D at 2 weeks Top of page

Secondary: EQ5D at 2 months Top of page
End point title	EQ5D at 2 months
End point description	EuroQol EQ5D (utility) -0.59 – 1.00 [-0.59=Worst health utility, 1.00=Best health utility]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 64 62 Units: score     arithmetic mean (standard deviation) 0.44 ( 0.29 ) 0.52 ( 0.24 ) 0.60 ( 0.26 )
Statistical analysis title	EQ5D at 2 months
Statistical analysis description	EQ5D at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.15
Confidence interval
level	95%
sides	2-sided
lower limit	0.08
upper limit	0.22
Variability estimate	Standard error of the mean
Statistical analysis title	EQ5D at 2 months
Statistical analysis description	EQ5D at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.042
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.07
Confidence interval
level	95%
sides	2-sided
lower limit	0
upper limit	0.14
Variability estimate	Standard error of the mean

Secondary: EQ5D at 2 months Top of page

Secondary: EQ5D at 4 months Top of page
End point title	EQ5D at 4 months
End point description	EuroQol EQ5D (utility) -0.59 – 1.00 [-0.59=Worst health utility, 1.00=Best health utility]
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 62 58 Units: score     arithmetic mean (standard deviation) 0.48 ( 0.28 ) 0.48 ( 0.28 ) 0.59 ( 0.23 )
Statistical analysis title	EQ5D at 4 months
Statistical analysis description	EQ5D at 4 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	114
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.004
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.12
Confidence interval
level	95%
sides	2-sided
lower limit	0.04
upper limit	0.19
Variability estimate	Standard error of the mean
Statistical analysis title	EQ5D at 4 months
Statistical analysis description	EQ5D at 4 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	120
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.007
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.1
Confidence interval
level	95%
sides	2-sided
lower limit	0.03
upper limit	0.18
Variability estimate	Standard error of the mean

Secondary: EQ5D at 4 months Top of page

Secondary: EQ5D at 6 months Top of page
End point title	EQ5D at 6 months
End point description	EuroQol EQ5D (utility) -0.59 – 1.00 [-0.59=Worst health utility, 1.00=Best health utility]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 54 60 57 Units: score     arithmetic mean (standard deviation) 0.52 ( 0.25 ) 0.50 ( 0.24 ) 0.50 ( 0.25 )
Statistical analysis title	EQ5D at 6 months
Statistical analysis description	EQ5D at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.889
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.01
Confidence interval
level	95%
sides	2-sided
lower limit	-0.07
upper limit	0.08
Variability estimate	Standard error of the mean
Statistical analysis title	EQ5D at 6 months
Statistical analysis description	EQ5D at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.914
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0
Confidence interval
level	95%
sides	2-sided
lower limit	-0.07
upper limit	0.08
Variability estimate	Standard error of the mean

Secondary: EQ5D at 6 months Top of page

Secondary: EQ5D - Overall Top of page
End point title	EQ5D - Overall
End point description	EuroQol EQ5D (utility) -0.59 – 1.00 [-0.59=Worst health utility, 1.00=Best health utility]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 weeks, 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 63 65 66 Units: score     arithmetic mean (standard deviation) 0.48 ( 0.27 ) 0.52 ( 0.25 ) 0.58 ( 0.25 )
Statistical analysis title	EQ5D - Overall
Statistical analysis description	EQ5D overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.11
Confidence interval
level	95%
sides	2-sided
lower limit	0.06
upper limit	0.17
Variability estimate	Standard error of the mean
Statistical analysis title	EQ5D - Overall
Statistical analysis description	EQ5D overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	131
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.034
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.06
Confidence interval
level	95%
sides	2-sided
lower limit	0.01
upper limit	0.11
Variability estimate	Standard error of the mean

Secondary: EQ5D - Overall Top of page

Secondary: SPS at 2 months Top of page
End point title	SPS at 2 months
End point description	Stanford Presenteeism Scale (SPS) 6-30 [6=Minimum ability, 30=Maximum ability]
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 22 27 35 Units: scale     arithmetic mean (standard deviation) 20.0 ( 6.0 ) 20.1 ( 6.0 ) 23.4 ( 4.4 )
Statistical analysis title	SPS at 2 months
Statistical analysis description	SPS at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	57
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	4.06
Confidence interval
level	95%
sides	2-sided
lower limit	1.75
upper limit	6.38
Variability estimate	Standard error of the mean
Statistical analysis title	SPS at 2 months
Statistical analysis description	SPS at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	62
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.4
Confidence interval
level	95%
sides	2-sided
lower limit	1.22
upper limit	5.59
Variability estimate	Standard error of the mean

Secondary: SPS at 2 months Top of page

Secondary: SPS at 6 months Top of page
End point title	SPS at 6 months
End point description	Stanford Presenteeism Scale (SPS) 6-30 [6=Minimum ability, 30=Maximum ability]
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 21 26 32 Units: score     arithmetic mean (standard deviation) 19.9 ( 6.6 ) 20.0 ( 4.7 ) 21.8 ( 5.1 )
Statistical analysis title	SPS at 6 months
Statistical analysis description	SPS at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	53
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.073
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.16
Confidence interval
level	95%
sides	2-sided
lower limit	-0.2
upper limit	4.53
Variability estimate	Standard error of the mean
Statistical analysis title	SPS at 6 months
Statistical analysis description	SPS at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	58
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.031
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.45
Confidence interval
level	95%
sides	2-sided
lower limit	0.22
upper limit	4.69
Variability estimate	Standard error of the mean

Secondary: SPS at 6 months Top of page

Secondary: SPS - Overall Top of page
End point title	SPS - Overall
End point description	Stanford Presenteeism Scale (SPS) 6-30 [6=Minimum ability, 30=Maximum ability]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 25 30 37 Units: score     arithmetic mean (standard deviation) 19.9 ( 6.2 ) 20.1 ( 5.4 ) 22.7 ( 4.8 )
Statistical analysis title	SPS - Overall
Statistical analysis description	SPS overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	62
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.003
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	3.11
Confidence interval
level	95%
sides	2-sided
lower limit	1.05
upper limit	5.18
Variability estimate	Standard error of the mean
Statistical analysis title	SPS - Overall
Statistical analysis description	SPS overall (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline SPS
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	67
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.003
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.93
Confidence interval
level	95%
sides	2-sided
lower limit	0.98
upper limit	4.88
Variability estimate	Standard error of the mean

Secondary: SPS - Overall Top of page

Secondary: Work performance at 2 months Top of page
End point title	Work performance at 2 months
End point description	Work Performance 0-10 numerical integer scale [0=Not at all affected, 10=Pain is so bad unable to do job] Question worded: On average to what extent has your hip pain affected your performance at work in the last 2 months since your clinical visit?
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 21 28 36 Units: score     arithmetic mean (standard deviation) 4.1 ( 3.0 ) 4.9 ( 3.0 ) 3.1 ( 2.4 )
Statistical analysis title	Work performance at 2 months
Statistical analysis description	WP at 2 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	57
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.005
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.72
Confidence interval
level	95%
sides	2-sided
lower limit	-2.93
upper limit	-0.51
Variability estimate	Standard error of the mean
Statistical analysis title	Work performance at 2 months
Statistical analysis description	WP at 2 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	64
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.011
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.49
Confidence interval
level	95%
sides	2-sided
lower limit	-2.64
upper limit	-0.34
Variability estimate	Standard error of the mean

Secondary: Work performance at 2 months Top of page

Secondary: Work performance at 6 months Top of page
End point title	Work performance at 6 months
End point description	Work Performance 0-10 numerical integer scale [0=Not at all affected, 10=Pain is so bad unable to do job] Question worded: On average to what extent has your hip pain affected your performance at work in the last 6 months since your clinical visit?
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 21 26 32 Units: score     arithmetic mean (standard deviation) 4.4 ( 3.2 ) 4.5 ( 2.7 ) 4.2 ( 2.7 )
Statistical analysis title	Work performance at 6 months
Statistical analysis description	WP at 6 months (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	53
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.182
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.84
Confidence interval
level	95%
sides	2-sided
lower limit	-2.08
upper limit	0.39
Variability estimate	Standard error of the mean
Statistical analysis title	Work performance at 6 months
Statistical analysis description	WP at 6 months (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	58
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.435
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.47
Confidence interval
level	95%
sides	2-sided
lower limit	-1.64
upper limit	0.71
Variability estimate	Standard error of the mean

Secondary: Work performance at 6 months Top of page

Secondary: Work performance - Overall Top of page
End point title	Work performance - Overall
End point description	Work Performance 0-10 numerical integer scale [0=Not at all affected, 10=Pain is so bad unable to do job]
End point type	Secondary
End point timeframe	Overall (all follow up scores: 2 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 24 30 38 Units: score     arithmetic mean (standard deviation) 4.3 ( 3.1 ) 4.7 ( 2.8 ) 3.6 ( 2.6 )
Statistical analysis title	Work performance - Overall
Statistical analysis description	WP overall (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	62
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.023
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.28
Confidence interval
level	95%
sides	2-sided
lower limit	-2.39
upper limit	-0.18
Variability estimate	Standard error of the mean
Statistical analysis title	Work performance - Overall
Statistical analysis description	WP overall (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WP
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	68
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.067
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.98
Confidence interval
level	95%
sides	2-sided
lower limit	-2.03
upper limit	0.07
Variability estimate	Standard error of the mean

Secondary: Work performance - Overall Top of page

Secondary: Perceived change at 2 weeks Top of page
End point title	Perceived change at 2 weeks
End point description	Perceived change at 2 weeks (6-point ordered categorical scale: completely better, much better, somewhat better, same, somewhat worse, much worse) Question worded: Compared to 2 weeks ago when you attended your hospital clinic appointment for your hip problem, how would you rate your hip problem now?
End point type	Secondary
End point timeframe	2 weeks
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 62 64 64 Units: participants     completely better 0 1 2     much better 0 15 34     somewhat better 7 20 14     same 39 23 10     somewhat worse 10 4 4     much worse 6 1 0
Statistical analysis title	Perceived change at 2 weeks
Statistical analysis description	Perceived change (specifically for this analysis (due to zero cell counts) dichotomsed as: completely better/much better/somewhat better and same/somewhat worse/much worse. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	6.93
Confidence interval
level	95%
sides	2-sided
lower limit	3.39
upper limit	14.2
Variability estimate	Standard error of the mean
Statistical analysis title	Perceived change at 2 weeks
Statistical analysis description	Perceived change (for analysis dichotomsed as: completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.009
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	2.28
Confidence interval
level	95%
sides	2-sided
lower limit	1.42
upper limit	3.66
Variability estimate	Standard error of the mean

Secondary: Perceived change at 2 weeks Top of page

Secondary: Perceived change at 2 months Top of page
End point title	Perceived change at 2 months
End point description	Perceived change at 2 months (6-point ordered categorical scale: completely better, much better, somewhat better, same, somewhat worse, much worse) Question worded: Compared to 2 months ago when you attended your hospital clinic appointment for your hip problem, how would you rate your hip problem now?
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 58 65 66 Units: participants     completely better 1 0 2     much better 3 11 28     somewhat better 6 21 9     same 27 19 14     somewhat worse 16 12 9     much worse 5 2 4
Statistical analysis title	Perceived change at 2 months
Statistical analysis description	Perceived change (dichotomsed as completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	6.66
Confidence interval
level	95%
sides	2-sided
lower limit	2.48
upper limit	17.9
Variability estimate	Standard error of the mean
Statistical analysis title	Perceived change at 2 months
Statistical analysis description	Perceived improvement: completely better/much better & somewhat better/same/somewhat worse/much worse Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	2.63
Confidence interval
level	95%
sides	2-sided
lower limit	1.43
upper limit	4.82
Variability estimate	Standard error of the mean

Secondary: Perceived change at 2 months Top of page

Secondary: Perceived change at 4 months Top of page
End point title	Perceived change at 4 months
End point description	Perceived change at 4 months (6-point ordered categorical scale: completely better, much better, somewhat better, same, somewhat worse, much worse) Question worded: Compared to 4 months ago when you attended your hospital clinic appointment for your hip problem, how would you rate your hip problem now?
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 57 63 60 Units: participants     completely better 0 0 1     much better 10 9 15     somewhat better 5 10 15     same 17 24 14     somewhat worse 16 14 13     much worse 9 6 2
Statistical analysis title	Perceived change at 4 months
Statistical analysis description	Perceived change (for analysis dichotomsed: as completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.234
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.54
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	3.11
Variability estimate	Standard error of the mean
Statistical analysis title	Perceived change at 4 months
Statistical analysis description	Perceived change (for analysis dichotomsed: as completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	123
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.105
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.85
Confidence interval
level	95%
sides	2-sided
lower limit	0.88
upper limit	3.88
Variability estimate	Standard error of the mean

Secondary: Perceived change at 4 months Top of page

Secondary: Perceived change at 6 months Top of page
End point title	Perceived change at 6 months
End point description	Perceived change at 6 months (6-point ordered categorical scale: completely better, much better, somewhat better, same, somewhat worse, much worse) Question worded: Compared to 6 months ago when you attended your hospital clinic appointment for your hip problem, how would you rate your hip problem now?
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 61 61 Units: participants     completely better 2 0 1     much better 10 11 13     somewhat better 7 12 13     same 14 18 13     somewhat worse 14 15 18     much worse 9 5 3
Statistical analysis title	Perceived change at 6 months
Statistical analysis description	Perceived change (for analysis dichotomsed: as completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.794
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.1
Confidence interval
level	95%
sides	2-sided
lower limit	0.55
upper limit	2.17
Variability estimate	Standard error of the mean
Statistical analysis title	Perceived change at 6 months
Statistical analysis description	Perceived change (for analysis dichotomsed: as completely better/much better and somewhat better/same/somewhat worse/much worse). Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.516
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.27
Confidence interval
level	95%
sides	2-sided
lower limit	0.62
upper limit	2.58
Variability estimate	Standard error of the mean

Secondary: Perceived change at 6 months Top of page

Secondary: Sleep difficulty at 2 months Top of page
End point title	Sleep difficulty at 2 months
End point description	Nights with sleep difficulty during past 4 weeks (5-point ordered categorical scale: no nights, only 1 or 2 nights, some nights, most nights, every night)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 62 63 Units: participants     no nights 4 7 12     1-2 nights 5 5 16     some nights 17 19 15     most nights 15 17 12     every night 14 14 8
Statistical analysis title	Sleep difficulty at 2 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.002
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.96
Confidence interval
level	95%
sides	2-sided
lower limit	1.28
upper limit	3.03
Variability estimate	Standard error of the mean
Statistical analysis title	Sleep difficulty at 2 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.013
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.72
Confidence interval
level	95%
sides	2-sided
lower limit	1.12
upper limit	2.63
Variability estimate	Standard error of the mean

Secondary: Sleep difficulty at 2 months Top of page

Secondary: Sleep difficulty at 4 months Top of page
End point title	Sleep difficulty at 4 months
End point description	Nights with sleep difficulty during past 4 weeks (5-point ordered categorical scale: no nights, only 1 or 2 nights, some nights, most nights, every night)
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 54 61 59 Units: participants     no nights 8 6 9     1-2 nights 9 9 13     some nights 16 12 15     most nights 13 25 14     every night 8 11 8
Statistical analysis title	Sleep difficulty at 4 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	113
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.314
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.27
Confidence interval
level	95%
sides	2-sided
lower limit	0.79
upper limit	2.04
Variability estimate	Standard error of the mean
Statistical analysis title	Sleep difficulty at 4 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	120
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.022
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.56
Confidence interval
level	95%
sides	2-sided
lower limit	1.06
upper limit	2.27
Variability estimate	Standard error of the mean

Secondary: Sleep difficulty at 4 months Top of page

Secondary: Sleep difficulty at 6 months Top of page
End point title	Sleep difficulty at 6 months
End point description	Nights with sleep difficulty during past 4 weeks (5-point ordered categorical scale: no nights, only 1 or 2 nights, some nights, most nights, every night)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 60 57 Units: participants     no nights 9 7 8     1-2 nights 6 5 5     some nights 15 16 14     most nights 15 21 15     every night 7 11 15
Statistical analysis title	Sleep difficulty at 6 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	109
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.799
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.06
Confidence interval
level	95%
sides	2-sided
lower limit	0.69
upper limit	1.61
Variability estimate	Standard error of the mean
Statistical analysis title	Sleep difficulty at 6 months
Statistical analysis description	For analysis categories were dichotomised as: no nights/1-2 nights/ some nights & most nights/every night. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender, baseline pain and baseline sleep.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.586
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.1
Confidence interval
level	95%
sides	2-sided
lower limit	0.79
upper limit	1.52
Variability estimate	Standard error of the mean

Secondary: Sleep difficulty at 6 months Top of page

Secondary: Satisfaction with care received at 2 months Top of page
End point title	Satisfaction with care received at 2 months
End point description	Question worded: How satisfied are you with the care you have received for your hip problem in the last 2 months? Response options on 5-point ordered categorical scale: very satisfied, quite satisfied, no opinion, not very satisfied, not at all satisfied
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 62 57 Units: participants     very satisfied 6 14 27     quite satisfied 13 14 14     no opinion 15 22 9     not very satisfied 10 7 5     not at all satisfied 7 5 2
Statistical analysis title	Satisfaction with care received at 2 months
Statistical analysis description	For analysis dichtomisation was as follows: very satisfied/quite satisfied & no opinion/not very satisfied/ not at all satisfied. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	108
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.97
Confidence interval
level	95%
sides	2-sided
lower limit	1.33
upper limit	2.93
Variability estimate	Standard error of the mean
Statistical analysis title	Satisfaction with care received at 2 months
Statistical analysis description	For analysis dichtomisation was as follows: very satisfied/quite satisfied & no opinion/not very satisfied/ not at all satisfied. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.004
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.61
Confidence interval
level	95%
sides	2-sided
lower limit	1.17
upper limit	2.21
Variability estimate	Standard error of the mean

Secondary: Satisfaction with care received at 2 months Top of page

Secondary: Satisfaction with care received at 6 months Top of page
End point title	Satisfaction with care received at 6 months
End point description	Question worded: How satisfied are you with the care you have received for your hip problem in the last 4 months? Response options on 5-point ordered categorical scale: very satisfied, quite satisfied, no opinion, not very satisfied, not at all satisfied
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 57 55 Units: participants     very satisfied 6 17 15     quite satisfied 12 19 17     no opinion 20 15 12     not very satisfied 10 6 7     not at all satisfied 4 0 4
Statistical analysis title	Satisfaction with care received at 6 months
Statistical analysis description	For analysis dichtomisation was as follows: very satisfied/quite satisfied & no opinion/not very satisfied/ not at all satisfied. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	107
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.016
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.72
Confidence interval
level	95%
sides	2-sided
lower limit	1.11
upper limit	2.66
Variability estimate	Standard error of the mean
Statistical analysis title	Satisfaction with care received at 6 months
Statistical analysis description	For analysis dichtomisation was as follows: very satisfied/quite satisfied & no opinion/not very satisfied/ not at all satisfied. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	112
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.63
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	0.93
Confidence interval
level	95%
sides	2-sided
lower limit	0.69
upper limit	1.25
Variability estimate	Standard error of the mean

Secondary: Satisfaction with care received at 6 months Top of page

Secondary: Rating of overall results of care at 2 months Top of page
End point title	Rating of overall results of care at 2 months
End point description	Question worded: How would you rate the overall results of the care for your hip problem? (0-10 scale; 0=terrible, 10=excellent)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 50 61 57 Units: score     arithmetic mean (standard deviation) 4.7 ( 3.3 ) 5.8 ( 3.3 ) 7.2 ( 2.6 )
Statistical analysis title	Rating of overall results of care at 2 months
Statistical analysis description	Mean difference for BCT+US-T minus BCT adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	107
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.51
Confidence interval
level	95%
sides	2-sided
lower limit	1.4
upper limit	3.61
Variability estimate	Standard error of the mean
Statistical analysis title	Rating of overall results of care at 2 months
Statistical analysis description	Mean difference for BCT+US-T minus BCT+US-L adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.008
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	1.43
Confidence interval
level	95%
sides	2-sided
lower limit	0.38
upper limit	2.47
Variability estimate	Standard error of the mean

Secondary: Rating of overall results of care at 2 months Top of page

Secondary: Rating of overall results of care at 6 months Top of page
End point title	Rating of overall results of care at 6 months
End point description	Question worded: How would you rate the overall results of the care for your hip problem? (0-10 scale; 0=terrible, 10=excellent)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 58 55 Units: score     arithmetic mean (standard deviation) 5.0 ( 2.9 ) 6.6 ( 2.7 ) 6.6 ( 2.8 )
Statistical analysis title	Rating of overall results of care at 6 months
Statistical analysis description	Mean difference for BCT+US-T minus BCT adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	106
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.004
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	1.6
Confidence interval
level	95%
sides	2-sided
lower limit	0.5
upper limit	2.71
Variability estimate	Standard error of the mean
Statistical analysis title	Rating of overall results of care at 6 months
Statistical analysis description	Mean difference for BCT+US-T minus BCT+US-L adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	113
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.784
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.15
Confidence interval
level	95%
sides	2-sided
lower limit	-0.91
upper limit	1.21
Variability estimate	Standard error of the mean

Secondary: Rating of overall results of care at 6 months Top of page

Secondary: Expectation for pain relief at 2 months Top of page
End point title	Expectation for pain relief at 2 months
End point description	Question worded as: To what extent do you feel your expectations for pain relief have been met? Response options on 4-point ordered categorical scale: definitely not met, not met, no opinion, probably met
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 62 57 Units: participants     probably met 15 22 32     no opinion 11 13 8     not met 20 19 12     definitely not met 7 8 5
Statistical analysis title	Expectations for pain relief at 2 months
Statistical analysis description	For analysis dichotomisation was as follows: probably met/no opinion & not met/definitely not met. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	110
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.01
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.52
Confidence interval
level	95%
sides	2-sided
lower limit	1.1
upper limit	2.1
Variability estimate	Standard error of the mean
Statistical analysis title	Expectations for pain relief at 2 months
Statistical analysis description	For analysis dichotomisation was as follows: probably met/no opinion & not met/definitely not met. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.105
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.26
Confidence interval
level	95%
sides	2-sided
lower limit	0.95
upper limit	1.67
Variability estimate	Standard error of the mean

Secondary: Expectation for pain relief at 2 months Top of page

Secondary: Expectation for pain relief at 6 months Top of page
End point title	Expectation for pain relief at 6 months
End point description	Question worded as: To what extent do you feel your expectations for pain relief have been met? Response options on 4-point ordered categorical scale: definitely not met, not met, no opinion, probably met
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 59 57 Units: participants     probably met 17 22 25     no opinion 10 9 13     not met 15 20 13     definitely not met 9 8 6
Statistical analysis title	Expectation for pain relief at 6 months
Statistical analysis description	For analysis dichotomisation was as follows: probably met/no opinion & not met/definitely not met. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	108
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.059
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.35
Confidence interval
level	95%
sides	2-sided
lower limit	0.99
upper limit	1.84
Variability estimate	Standard error of the mean
Statistical analysis title	Expectations for pain relief at 6 months
Statistical analysis description	For analysis dichotomisation was as follows: probably met/no opinion & not met/definitely not met. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.098
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.29
Confidence interval
level	95%
sides	2-sided
lower limit	0.95
upper limit	1.73
Variability estimate	Standard error of the mean

Secondary: Expectation for pain relief at 6 months Top of page

Secondary: Same care again for hip problem at 2 months Top of page
End point title	Same care again for hip problem at 2 months
End point description	Question worded: Would you have the same care again if you had the same condition? Ordered 5-point categorical response options: definitely not, probably not, no opinion, probably, definitely
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 61 58 Units: participants     definitely 4 16 26     probably 11 14 15     no opinion 16 14 11     probably not 12 11 4     definitely not 8 6 2
Statistical analysis title	Same care again at 2 months
Statistical analysis description	Final analysis categories dichotomised as: definitely/probably & no opinion/probably not/definitely not. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	109
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	2.41
Confidence interval
level	95%
sides	2-sided
lower limit	1.53
upper limit	3.8
Variability estimate	Standard error of the mean
Statistical analysis title	Same care again at 2 months
Statistical analysis description	Final analysis categories dichotomised as: definitely/probably & no opinion/probably not/definitely not. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.016
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.45
Confidence interval
level	95%
sides	2-sided
lower limit	1.07
upper limit	1.96
Variability estimate	Standard error of the mean

Secondary: Same care again for hip problem at 2 months Top of page

Secondary: Same care again for hip problem at 6 months Top of page
End point title	Same care again for hip problem at 6 months
End point description	Question worded: Would you have the same care again if you had the same condition? Ordered 5-point categorical response options: definitely not, probably not, no opinion, probably, definitely
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 49 58 54 Units: participants     definitely 6 17 18     probably 11 19 17     no opinion 20 10 10     probably not 7 7 5     definitely not 5 5 4
Statistical analysis title	Same care again at 6 months
Statistical analysis description	Final analysis categories dichotomised as: definitely/probably & no opinion/probably not/definitely not. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	103
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.004
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.89
Confidence interval
level	95%
sides	2-sided
lower limit	1.22
upper limit	2.92
Variability estimate	Standard error of the mean
Statistical analysis title	Same care again at 6 months
Statistical analysis description	Final analysis categories dichotomised as: definitely/probably & no opinion/probably not/definitely not. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	112
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.687
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.06
Confidence interval
level	95%
sides	2-sided
lower limit	0.8
upper limit	1.4
Variability estimate	Standard error of the mean

Secondary: Same care again for hip problem at 6 months Top of page

Secondary: Satisfaction with information received at 2 months Top of page
End point title	Satisfaction with information received at 2 months
End point description	Question worded: How satisfied are you with the information you received concerning your hip problem? 5-point ordered categorical response options: very satisfied, quite satisfied, no opinion, not very satisfied, not at all satisfied
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 61 62 Units: participants     very satisfied 15 28 35     quite satisfied 23 20 21     no opinion 5 5 1     not very satisfied 6 7 3     not at all satisfied 7 1 2
Statistical analysis title	Satisfaction with information received at 2 months
Statistical analysis description	Final analysis category dichotomisation: very satisfied/quite satisfied & no opinion/not very satisfied/not at all satisfied. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.004
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.35
Confidence interval
level	95%
sides	2-sided
lower limit	1.1
upper limit	1.64
Variability estimate	Standard error of the mean
Statistical analysis title	Satisfaction with information received at 2 months
Statistical analysis description	Final analysis category dichotomisation: very satisfied/quite satisfied & no opinion/not very satisfied/not at all satisfied. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	123
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.07
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.15
Confidence interval
level	95%
sides	2-sided
lower limit	0.99
upper limit	1.34
Variability estimate	Standard error of the mean

Secondary: Satisfaction with information received at 2 months Top of page

Secondary: Satisfaction with information received at 6 months Top of page
End point title	Satisfaction with information received at 6 months
End point description	Question worded: How satisfied are you with the information you received concerning your hip problem? 5-point ordered categorical response options: very satisfied, quite satisfied, no opinion, not very satisfied, not at all satisfied
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 60 58 Units: participants     very satisfied 12 29 23     quite satisfied 20 21 19     no opinion 8 6 8     not very satisfied 9 4 6     not at all satisfied 3 0 2
Statistical analysis title	Satisfaction with information received at 6 months
Statistical analysis description	Final analysis category dichotomisation: very satisfied/quite satisfied & no opinion/not very satisfied/not at all satisfied. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	110
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.209
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.19
Confidence interval
level	95%
sides	2-sided
lower limit	0.91
upper limit	1.56
Variability estimate	Standard error of the mean
Statistical analysis title	Satisfaction with information received at 6 months
Statistical analysis description	Final analysis category dichotomisation: very satisfied/quite satisfied & no opinion/not very satisfied/not at all satisfied. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.174
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.15
Confidence interval
level	95%
sides	2-sided
lower limit	0.94
upper limit	1.4
Variability estimate	Standard error of the mean

Secondary: Satisfaction with information received at 6 months Top of page

Secondary: Understanding of hip problem at 2 months Top of page
End point title	Understanding of hip problem at 2 months
End point description	Question worded as: How well do you understand your hip problem? 4-point categorical response options of: very clearly, quite clearly, no opinion, not very clearly
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 62 62 Units: participants     very clearly 19 29 25     quite clearly 29 24 29     no opinion 2 5 1     not very clearly 6 4 7
Statistical analysis title	Understanding hip problem at 2 months
Statistical analysis description	Final analysis categories dichotomised as: very clearly/quite clearly & no opinion/not very clearly. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.884
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.01
Confidence interval
level	95%
sides	2-sided
lower limit	0.87
upper limit	1.17
Variability estimate	Standard error of the mean
Statistical analysis title	Understanding of hip problem at 2 months
Statistical analysis description	Final analysis categories dichotomised as: very clearly/quite clearly & no opinion/not very clearly. Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.797
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.02
Confidence interval
level	95%
sides	2-sided
lower limit	0.89
upper limit	1.17
Variability estimate	Standard error of the mean

Secondary: Understanding of hip problem at 2 months Top of page

Secondary: Understanding of hip problem at 6 months Top of page
End point title	Understanding of hip problem at 6 months
End point description	Question worded as: How well do you understand your hip problem? 4-point categorical response options of: very clearly, quite clearly, no opinion, not very clearly
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 60 58 Units: participants     very clearly 18 24 22     quite clearly 24 30 24     no opinion 5 1 5     not very clearly 5 5 7
Statistical analysis title	Understanding of hip problem at 6 months
Statistical analysis description	Final analysis categories dichotomised as: very clearly/quite clearly & no opinion/not very clearly. Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	110
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.813
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	0.98
Confidence interval
level	95%
sides	2-sided
lower limit	0.81
upper limit	1.18
Variability estimate	Standard error of the mean
Statistical analysis title	Understanding of hip problem at 6 months
Statistical analysis description	Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.104
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	0.88
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	1.03
Variability estimate	Standard error of the mean

Secondary: Understanding of hip problem at 6 months Top of page

Secondary: Still have questions at 2 months Top of page
End point title	Still have questions at 2 months
End point description	Question worded as: Do you still have questions about your hip problem? (yes/no)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 61 61 Units: participants     no 30 33 37     yes 25 28 24
Statistical analysis title	Still have questions at 2 months
Statistical analysis description	Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.446
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.19
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	1.82
Variability estimate	Standard error of the mean
Statistical analysis title	Still have questions at 2 months
Statistical analysis description	Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.486
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.16
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	1.75
Variability estimate	Standard error of the mean

Secondary: Still have questions at 2 months Top of page

Secondary: Still have questions at 6 months Top of page
End point title	Still have questions at 6 months
End point description	Question worded as: Do you still have questions about your hip problem? (yes/no)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 60 57 Units: participants     no 27 26 28     yes 25 34 29
Statistical analysis title	Still have questions at 6 months
Statistical analysis description	Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	109
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.844
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	0.96
Confidence interval
level	95%
sides	2-sided
lower limit	0.65
upper limit	1.43
Variability estimate	Standard error of the mean
Statistical analysis title	Still have questions at 6 months
Statistical analysis description	Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.481
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.14
Confidence interval
level	95%
sides	2-sided
lower limit	0.8
upper limit	1.61
Variability estimate	Standard error of the mean

Secondary: Still have questions at 6 months Top of page

Secondary: Kept from usual activities at 2 months Top of page
End point title	Kept from usual activities at 2 months
End point description	Question worded: Have you been kept from your usual activities (e.g. work, hobbies, housework) at any time in the last 2 months because of hip pain? (yes/no)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 62 60 Units: participants     no 25 32 40     yes 31 30 20
Statistical analysis title	Kept from usual activities at 2 months
Statistical analysis description	Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.009
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.79
Confidence interval
level	95%
sides	2-sided
lower limit	1.15
upper limit	2.7
Variability estimate	Standard error of the mean
Statistical analysis title	Kept from usual activities at 2 months
Statistical analysis description	Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.121
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.41
Confidence interval
level	95%
sides	2-sided
lower limit	0.91
upper limit	2.22
Variability estimate	Standard error of the mean

Secondary: Kept from usual activities at 2 months Top of page

Secondary: Kept from usual activities at 6 months Top of page
End point title	Kept from usual activities at 6 months
End point description	Question worded: Have you been kept from your usual activities (e.g. work, hobbies, housework) at any time in the last 4 months because of hip pain? (yes/no)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 55 Units: participants     no 25 28 27     yes 28 31 28
Statistical analysis title	Kept from usual activities at 6 months
Statistical analysis description	Comparison BCT+US-T v BCT (reference) adjusted for age, gender and baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	108
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.465
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.15
Confidence interval
level	95%
sides	2-sided
lower limit	0.79
upper limit	1.69
Variability estimate	Standard error of the mean
Statistical analysis title	Kept from usual activities at 6 months
Statistical analysis description	Comparison BCT+US-T v BCT+US-L (reference) adjusted for age, gender and baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	114
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.677
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.08
Confidence interval
level	95%
sides	2-sided
lower limit	0.76
upper limit	1.54
Variability estimate	Standard error of the mean

Secondary: Kept from usual activities at 6 months Top of page

Secondary: Pain score dichotomy at 2 weeks Top of page
End point title	Pain score dichotomy at 2 weeks
End point description	Evaluation of dichotomised follow up pain score (pain score <5; pain score>=5)
End point type	Secondary
End point timeframe	2 weeks
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 62 63 64 Units: participants     <5 16 32 44     >=5 46 31 20
Statistical analysis title	Pain >=5 at 2 weeks
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	2.73
Confidence interval
level	95%
sides	2-sided
lower limit	1.75
upper limit	4.26
Variability estimate	Standard error of the mean
Statistical analysis title	Pain >=5 at 2 weeks
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	127
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.028
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.37
Confidence interval
level	95%
sides	2-sided
lower limit	1.03
upper limit	1.82
Variability estimate	Standard error of the mean

Secondary: Pain score dichotomy at 2 weeks Top of page

Secondary: Pain score dichotomy at 2 months Top of page
End point title	Pain score dichotomy at 2 months
End point description	Evaluation of dichotomised follow up pain score (pain score <5; pain score>=5)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 58 65 64 Units: participants     <5 20 32 37     >=5 38 33 27
Statistical analysis title	Pain >=5 at 2 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.007
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.75
Confidence interval
level	95%
sides	2-sided
lower limit	1.16
upper limit	2.63
Variability estimate	Standard error of the mean
Statistical analysis title	Pain >=5 at 2 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.279
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.2
Confidence interval
level	95%
sides	2-sided
lower limit	0.87
upper limit	1.65
Variability estimate	Standard error of the mean

Secondary: Pain score dichotomy at 2 months Top of page

Secondary: Pain score dichotomy at 4 months Top of page
End point title	Pain score dichotomy at 4 months
End point description	Evaluation of dichotomised follow up pain score (pain score <5; pain score>=5)
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 57 63 59 Units: participants     <5 19 27 31     >=5 38 36 28
Statistical analysis title	Pain >=5 at 4 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.03
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.63
Confidence interval
level	95%
sides	2-sided
lower limit	1.05
upper limit	2.52
Variability estimate	Standard error of the mean
Statistical analysis title	Pain >=5 at 4 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.258
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.24
Confidence interval
level	95%
sides	2-sided
lower limit	0.85
upper limit	1.8
Variability estimate	Standard error of the mean

Secondary: Pain score dichotomy at 4 months Top of page

Secondary: Pain score dichotomy at 6 months Top of page
End point title	Pain score dichotomy at 6 months
End point description	Evaluation of dichotomised follow up pain score (pain score <5; pain score>=5)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 56 61 61 Units: participants     <5 24 23 25     >=5 32 38 36
Statistical analysis title	Pain >=5 at 6 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.97
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	0.99
Confidence interval
level	95%
sides	2-sided
lower limit	0.66
upper limit	1.5
Variability estimate	Standard error of the mean
Statistical analysis title	Pain >=5 at 6 months
Statistical analysis description	Pain dichotomy (0-4, 5-10). Difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	122
Analysis specification	Pre-specified
Analysis type	superiority
Method	Mixed models analysis
Parameter type	Risk ratio (RR)
Point estimate	1.1
Confidence interval
level	95%
sides	2-sided
lower limit	0.72
upper limit	1.7
Variability estimate	Standard error of the mean

Secondary: Pain score dichotomy at 6 months Top of page

Secondary: WOMAC - Pain subscale at 2 months Top of page
End point title	WOMAC - Pain subscale at 2 months
End point description	WOMAC pain subscale (0-20; 0=no pain, 20=max pain)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 57 62 61 Units: scale     arithmetic mean (standard deviation) 10.7 ( 3.8 ) 8.7 ( 4.1 ) 7.0 ( 4.3 )
Statistical analysis title	WOMAC pain subscale at 2 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-3.61
Confidence interval
level	95%
sides	2-sided
lower limit	-5.02
upper limit	-2.2
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC pain subscale at 2 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	123
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.013
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.74
Confidence interval
level	95%
sides	2-sided
lower limit	-3.1
upper limit	-0.37
Variability estimate	Standard error of the mean

Secondary: WOMAC - Pain subscale at 2 months Top of page

Secondary: WOMAC - Pain subscale at 4 months Top of page
End point title	WOMAC - Pain subscale at 4 months
End point description	WOMAC pain subscale (0-20; 0=no pain, 20=max pain)
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 59 Units: scale     arithmetic mean (standard deviation) 9.0 ( 4.6 ) 9.1 ( 4.1 ) 7.9 ( 4.3 )
Statistical analysis title	WOMAC pain subscale at 4 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	112
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.087
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.25
Confidence interval
level	95%
sides	2-sided
lower limit	-2.67
upper limit	0.18
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC pain subscale at 4 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	118
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.079
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.24
Confidence interval
level	95%
sides	2-sided
lower limit	-2.62
upper limit	0.14
Variability estimate	Standard error of the mean

Secondary: WOMAC - Pain subscale at 4 months Top of page

Secondary: WOMAC - Pain subscale at 6 months Top of page
End point title	WOMAC - Pain subscale at 6 months
End point description	WOMAC pain subscale (0-20; 0=no pain, 20=max pain)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 60 56 Units: scale     arithmetic mean (standard deviation) 9.0 ( 4.5 ) 9.1 ( 4.1 ) 8.8 ( 4.3 )
Statistical analysis title	WOMAC pain subscale at 6 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	109
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.738
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.47
Confidence interval
level	95%
sides	2-sided
lower limit	-1.91
upper limit	0.97
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC pain subscale at 6 months
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.738
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.24
Confidence interval
level	95%
sides	2-sided
lower limit	-1.63
upper limit	1.15
Variability estimate	Standard error of the mean

Secondary: WOMAC - Pain subscale at 6 months Top of page

Secondary: WOMAC - Pain subscale overall Top of page
End point title	WOMAC - Pain subscale overall
End point description	WOMAC pain subscale (0-20; 0=no pain, 20=severe pain)
End point type	Secondary
End point timeframe	Overall (all data across 2 months, 4 months, 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 61 65 64 Units: scale     arithmetic mean (standard deviation) 9.6 ( 4.4 ) 9.0 ( 4.1 ) 7.9 ( 4.3 )
Statistical analysis title	WOMAC pain subscale - Overall
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.005
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.78
Confidence interval
level	95%
sides	2-sided
lower limit	-3.01
upper limit	-0.54
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC pain subscale - Overall
Statistical analysis description	WOMAC mean pain difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC pain.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.079
Method	Mixed models analysis
Parameter type	Mean difference (net)
Point estimate	-1.07
Confidence interval
level	95%
sides	2-sided
lower limit	-2.26
upper limit	0.12
Variability estimate	Standard error of the mean

Secondary: WOMAC - Pain subscale overall Top of page

Secondary: WOMAC - Stiffness subscale at 2 months Top of page
End point title	WOMAC - Stiffness subscale at 2 months
End point description	WOMAC stiffness subscale (0-8; 0=no stiffness, 8=max stiffness)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 57 63 63 Units: scale     arithmetic mean (standard deviation) 4.3 ( 1.9 ) 3.7 ( 1.7 ) 3.2 ( 1.9 )
Statistical analysis title	WOMAC stiffness subscale at 2 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	120
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.24
Confidence interval
level	95%
sides	2-sided
lower limit	-1.87
upper limit	-0.62
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC stiffness subscale at 2 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.088
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.53
Confidence interval
level	95%
sides	2-sided
lower limit	-1.14
upper limit	0.08
Variability estimate	Standard error of the mean

Secondary: WOMAC - Stiffness subscale at 2 months Top of page

Secondary: WOMAC - Stiffness subscale at 4 months Top of page
End point title	WOMAC - Stiffness subscale at 4 months
End point description	WOMAC stiffness subscale (0-8; 0=no stiffness, 8=max stiffness)
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 60 60 Units: scale     arithmetic mean (standard deviation) 3.8 ( 1.9 ) 3.8 ( 1.8 ) 3.7 ( 1.9 )
Statistical analysis title	WOMAC stiffness subscale at 4 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	113
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.445
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.25
Confidence interval
level	95%
sides	2-sided
lower limit	-0.89
upper limit	0.39
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC stiffness subscale at 4 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	120
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.714
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.12
Confidence interval
level	95%
sides	2-sided
lower limit	-0.73
upper limit	0.5
Variability estimate	Standard error of the mean

Secondary: WOMAC - Stiffness subscale at 4 months Top of page

Secondary: WOMAC - Stiffness subscale at 6 months Top of page
End point title	WOMAC - Stiffness subscale at 6 months
End point description	WOMAC stiffness subscale (0-8; 0=no stiffness, 8=max stiffness)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 56 Units: scale     arithmetic mean (standard deviation) 3.7 ( 1.9 ) 3.8 ( 1.8 ) 3.7 ( 1.7 )
Statistical analysis title	WOMAC stiffness subscale at 6 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	109
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.866
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.11
Confidence interval
level	95%
sides	2-sided
lower limit	-0.75
upper limit	0.54
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC stiffness subscale at 6 months
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	115
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.749
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.05
Confidence interval
level	95%
sides	2-sided
lower limit	-0.68
upper limit	0.57
Variability estimate	Standard error of the mean

Secondary: WOMAC - Stiffness subscale at 6 months Top of page

Secondary: WOMAC - Stiffness subscale - Overall Top of page
End point title	WOMAC - Stiffness subscale - Overall
End point description	WOMAC Stiffness subscale (0-8; 0=no stiffness, 8=max stiffness)
End point type	Secondary
End point timeframe	Overall (all data across 2, 4 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 61 65 65 Units: scale     arithmetic mean (standard deviation) 3.9 ( 1.9 ) 3.8 ( 1.8 ) 3.5 ( 1.8 )
Statistical analysis title	WOMAC stiffness subscale Overall
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	126
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.389
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.53
Confidence interval
level	95%
sides	2-sided
lower limit	-1.08
upper limit	0.01
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC stiffness subscale Overall
Statistical analysis description	WOMAC mean stiffness difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC stiffness.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.056
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.23
Confidence interval
level	95%
sides	2-sided
lower limit	-0.76
upper limit	0.3
Variability estimate	Standard error of the mean

Secondary: WOMAC - Stiffness subscale - Overall Top of page

Secondary: WOMAC - Function subscale at 2 months Top of page
End point title	WOMAC - Function subscale at 2 months
End point description	WOMAC function subscale (0-68; 0=no functional limitation, 68=max functional limitation)
End point type	Secondary
End point timeframe	2 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 55 63 62 Units: scale     arithmetic mean (standard deviation) 35.3 ( 16.1 ) 29.1 ( 14.3 ) 23.8 ( 15.0 )
Statistical analysis title	WOMAC function subscale at 2 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	117
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-10.4
Confidence interval
level	95%
sides	2-sided
lower limit	-14.8
upper limit	5.95
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC function subscale at 2 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.002
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-4.94
Confidence interval
level	95%
sides	2-sided
lower limit	-9.19
upper limit	-0.7
Variability estimate	Standard error of the mean

Secondary: WOMAC - Function subscale at 2 months Top of page

Secondary: WOMAC function subscale at 4 months Top of page
End point title	WOMAC function subscale at 4 months
End point description	WOMAC function subscale (0-68; 0=no functional limitation, 68=max functional limitation)
End point type	Secondary
End point timeframe	4 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 51 59 60 Units: scale     arithmetic mean (standard deviation) 30.7 ( 17.2 ) 31.3 ( 13.5 ) 26.7 ( 15.1 )
Statistical analysis title	WOMAC function subscale at 4 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	111
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.034
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-4.81
Confidence interval
level	95%
sides	2-sided
lower limit	-9.23
upper limit	-0.37
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC function subscale at 4 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	119
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.025
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-4.89
Confidence interval
level	95%
sides	2-sided
lower limit	-9.16
upper limit	-0.61
Variability estimate	Standard error of the mean

Secondary: WOMAC function subscale at 4 months Top of page

Secondary: WOMAC - Function subscale at 6 months Top of page
End point title	WOMAC - Function subscale at 6 months
End point description	WOMAC function subscale (0-68; 0=no functional limitation, 68=max functional limitation)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 53 59 57 Units: scale     arithmetic mean (standard deviation) 30.2 ( 16.7 ) 31.0 ( 14.3 ) 28.8 ( 15.2 )
Statistical analysis title	WOMAC function subscale at 6 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	110
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.587
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-1.25
Confidence interval
level	95%
sides	2-sided
lower limit	-5.74
upper limit	3.25
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC function subscale at 6 months
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	116
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.666
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.96
Confidence interval
level	95%
sides	2-sided
lower limit	-5.3
upper limit	3.38
Variability estimate	Standard error of the mean

Secondary: WOMAC - Function subscale at 6 months Top of page

Secondary: WOMAC - Function subscale Overall Top of page
End point title	WOMAC - Function subscale Overall
End point description	WOMAC function subscale (0-68; 0=no functional limitation, 68=max functional limitation)
End point type	Secondary
End point timeframe	Overall (all data across 2, 4 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 60 65 65 Units: scale     arithmetic mean (standard deviation) 32.1 ( 16.7 ) 30.4 ( 14.0 ) 26.4 ( 15.1 )
Statistical analysis title	WOMAC function subscale Overall
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	125
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.007
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-5.47
Confidence interval
level	95%
sides	2-sided
lower limit	-9.41
upper limit	-1.53
Variability estimate	Standard error of the mean
Statistical analysis title	WOMAC function subscale Overall
Statistical analysis description	WOMAC mean function subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline WOMAC function score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.064
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-3.6
Confidence interval
level	95%
sides	2-sided
lower limit	-7.4
upper limit	0.21
Variability estimate	Standard error of the mean

Secondary: WOMAC - Function subscale Overall Top of page

Secondary: IPQ Consequences subscale Overall Top of page
End point title	IPQ Consequences subscale Overall
End point description	IPQ consequences subscale (0-10; 0=No affect at all, 10=Severly affects life)
End point type	Secondary
End point timeframe	Overall (all data for 2 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 59 65 65 Units: scale     arithmetic mean (standard deviation) 6.0 ( 2.6 ) 5.9 ( 2.3 ) 5.5 ( 2.7 )
Statistical analysis title	IPQ Consequences subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.133
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.55
Confidence interval
level	95%
sides	2-sided
lower limit	-1.27
upper limit	0.17
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ Consequences subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.326
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.35
Confidence interval
level	95%
sides	2-sided
lower limit	-1.04
upper limit	0.35
Variability estimate	Standard error of the mean

Secondary: IPQ Consequences subscale Overall Top of page

Secondary: IPQ Timeline subscale Overall Top of page
End point title	IPQ Timeline subscale Overall
End point description	IPQ timelines subscale (0-10; 0=Last very short time, 10=Last forever)
End point type	Secondary
End point timeframe	Overall (all data across 2 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 59 65 65 Units: scale     arithmetic mean (standard deviation) 8.7 ( 2.1 ) 8.4 ( 2.2 ) 8.7 ( 2.2 )
Statistical analysis title	IPQ Timeline subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.847
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.07
Confidence interval
level	95%
sides	2-sided
lower limit	-0.74
upper limit	0.6
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ Timeline subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.228
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.4
Confidence interval
level	95%
sides	2-sided
lower limit	-0.25
upper limit	1.05
Variability estimate	Standard error of the mean

Secondary: IPQ Timeline subscale Overall Top of page

Secondary: IPQ Personal control subscale Top of page
End point title	IPQ Personal control subscale
End point description	IPQ personal control subscale (0-10; 0=No control, 10=Extreme control)
End point type	Secondary
End point timeframe	Overall (across 2 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 59 65 65 Units: scale     arithmetic mean (standard deviation) 4.3 ( 2.7 ) 4.2 ( 2.7 ) 4.5 ( 2.9 )
Statistical analysis title	IPQ Personal control Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-T v Best Current Treatment
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.777
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.12
Confidence interval
level	95%
sides	2-sided
lower limit	-0.93
upper limit	0.69
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ Personal control subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.519
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.25
Confidence interval
level	95%
sides	2-sided
lower limit	-0.52
upper limit	1.03
Variability estimate	Standard error of the mean

Secondary: IPQ Personal control subscale Top of page

Secondary: IPQ Treatment control subscale Overall Top of page
End point title	IPQ Treatment control subscale Overall
End point description	IPQ treatment control subscale (0-10; 0=Treatment no help, 10=Treatment extremely helpful)
End point type	Secondary
End point timeframe	Overall (across 2 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 59 65 64 Units: scale     arithmetic mean (standard deviation) 3.9 ( 2.9 ) 5.0 ( 3.1 ) 6.1 ( 3.2 )
Statistical analysis title	IPQ Treatment control subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	123
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.001
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	2.13
Confidence interval
level	95%
sides	2-sided
lower limit	1.11
upper limit	3.15
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ Treatment control subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	129
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.048
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	0.98
Confidence interval
level	95%
sides	2-sided
lower limit	0.01
upper limit	1.95
Variability estimate	Standard error of the mean

Secondary: IPQ Treatment control subscale Overall Top of page

Secondary: IPQ Emotional response subscale Overall Top of page
End point title	IPQ Emotional response subscale Overall
End point description	IPQ emotional response subscale (0-10; 0=Not affected emotionally, 10=Extremely affected emotionally)
End point type	Secondary
End point timeframe	Overall (all data across 2 and 6 months)
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 59 65 65 Units: scale     arithmetic mean (standard deviation) 5.2 ( 2.9 ) 4.8 ( 2.9 ) 4.7 ( 3.1 )
Statistical analysis title	IPQ Emotional response subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	124
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.116
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.63
Confidence interval
level	95%
sides	2-sided
lower limit	-1.43
upper limit	0.16
Variability estimate	Standard error of the mean
Statistical analysis title	IPQ Emotional response subscale Overall
Statistical analysis description	Mean subscale difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline IPQ subscale score.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	130
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.268
Method	Mixed models analysis
Parameter type	Mean difference (final values)
Point estimate	-0.43
Confidence interval
level	95%
sides	2-sided
lower limit	-1.19
upper limit	0.33
Variability estimate	Standard error of the mean

Secondary: IPQ Emotional response subscale Overall Top of page

Secondary: QALYs Top of page
End point title	QALYs [1]
End point description	Calculation of Quality-Adjusted-Life-Years by linear interpolation of EQ5D values for baseline through 2 weeks, 2 months, 4 months and 6 months (with imputation of missing EQ5D data via multiple imputation)
End point type	Secondary
End point timeframe	Overall (Baseline through to 6 months follow up)
Notes [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: QALYs are derived from measures of EQ5D at all timepoints and hence can not be reported solely at baseline or any other time point.
End point values Best Current Treatment BCT+US-T Number of subjects analysed 67 66 Units: scale     arithmetic mean (standard deviation) 0.218 ( 0.110 ) 0.264 ( 0.102 )
Statistical analysis title	QALYs
Statistical analysis description	Mean QALYs difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline EQ5D score.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	133
Analysis specification	Pre-specified
Analysis type	superiority
Method	Regression, Linear
Parameter type	Mean difference (final values)
Point estimate	0.048
Confidence interval
level	95%
sides	2-sided
lower limit	0.026
upper limit	0.07
Variability estimate	Standard error of the mean

Secondary: QALYs Top of page

Secondary: NHS costs Top of page
End point title	NHS costs [2]
End point description	Total UK National Health Service Costs (GBP, £)
End point type	Secondary
End point timeframe	Overall (baseline through 6 months follow up)
Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: NHS costs are assessed between baseline and 6 months and were not collected at baseline.
End point values Best Current Treatment BCT+US-T Number of subjects analysed 67 66 Units: pounds (GBP)     arithmetic mean (standard deviation) 327.45 ( 1188.68 ) 165.85 ( 212.71 )
Statistical analysis title	NHS cost difference
Statistical analysis description	Mean NHS cost (£) difference (BCT+US-T minus BCT)
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	133
Analysis specification	Pre-specified
Analysis type	superiority
Method	Regression, Linear
Parameter type	Mean difference (final values)
Point estimate	-161.59
Confidence interval
level	95%
sides	2-sided
lower limit	-583.95
upper limit	54.18
Variability estimate	Standard error of the mean

Secondary: NHS costs Top of page

Secondary: BMI at 6 months Top of page
End point title	BMI at 6 months
End point description	Body Mass Index at 6 months (kg/m2)
End point type	Secondary
End point timeframe	6 months
End point values Best Current Treatment BCT+US-L BCT+US-T Number of subjects analysed 52 57 56 Units: kg/m2     arithmetic mean (standard deviation) 29.2 ( 6.1 ) 28.0 ( 4.7 ) 29.2 ( 5.4 )
Statistical analysis title	BMI at 6 months
Statistical analysis description	Mean difference (BCT+US-T minus BCT) adjusted for age, gender, baseline pain and baseline BMI.
Comparison groups	Best Current Treatment v BCT+US-T
Number of subjects included in analysis	108
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.521
Method	Regression, Linear
Parameter type	Mean difference (final values)
Point estimate	-0.22
Confidence interval
level	95%
sides	2-sided
lower limit	-0.91
upper limit	0.46
Variability estimate	Standard error of the mean
Statistical analysis title	BMI at 6 months
Statistical analysis description	Mean difference (BCT+US-T minus BCT+US-L) adjusted for age, gender, baseline pain and baseline BMI.
Comparison groups	BCT+US-L v BCT+US-T
Number of subjects included in analysis	113
Analysis specification	Pre-specified
Analysis type	superiority
P-value	= 0.769
Method	Regression, Linear
Parameter type	Mean difference (final values)
Point estimate	0.1
Confidence interval
level	95%
sides	2-sided
lower limit	-0.55
upper limit	0.74
Variability estimate	Standard error of the mean

Secondary: BMI at 6 months Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	6 months
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	CTCAE
Dictionary version	4.0
Reporting groups
Reporting group title	Best Current Treatment
Reporting group description	BCT comprised written information (Arthritis Research UK Osteoarthritis leaflet and a bespoke leaflet on exercise and functional activities), personalised advice and information about weight loss, exercise, footwear, walking aids and optimising pain management, delivered within the clinic visit.
Reporting group title	BCT+US-L
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 5ml 1% lidocaine only.
Reporting group title	BCT+US-T
Reporting group description	Best Current Treatment (BCT) combined with an ultra-sound guided injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride.
Serious adverse events Best Current Treatment BCT+US-L BCT+US-T Total subjects affected by serious adverse events      subjects affected / exposed 2 / 67 (2.99%) 2 / 65 (3.08%) 3 / 65 (4.62%)      number of deaths (all causes) 0 0 2      number of deaths resulting from adverse events 0 0 2 Cardiac disorders Myocardial infarction      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 Chest pain      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 Nervous system disorders Multiple sclerosis relapse      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 Cerebrovascular accident      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 1 Gastrointestinal disorders Colitis      subjects affected / exposed 1 / 67 (1.49%) 0 / 65 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Osteonecrosis      subjects affected / exposed 1 / 67 (1.49%) 0 / 65 (0.00%) 0 / 65 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 Infections and infestations Endocarditis      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences causally related to treatment / all 0 / 0 0 / 0 1 / 1      deaths causally related to treatment / all 0 / 0 0 / 0 1 / 1
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events Best Current Treatment BCT+US-L BCT+US-T Total subjects affected by non serious adverse events      subjects affected / exposed 2 / 67 (2.99%) 26 / 65 (40.00%) 25 / 65 (38.46%) Injury, poisoning and procedural complications Bruising alternative assessment type: Systematic      subjects affected / exposed 0 / 67 (0.00%) 16 / 65 (24.62%) 15 / 65 (23.08%)      occurrences all number 0 16 15 Fall      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 0 / 65 (0.00%)      occurrences all number 0 1 0 Vascular disorders Flushing alternative assessment type: Systematic      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 4 / 65 (6.15%)      occurrences all number 0 0 4 Nervous system disorders Headache      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 0 / 65 (0.00%)      occurrences all number 0 1 0 Nervous system disorders - Other, specify Additional description: Restless legs      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Neuralgia      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 0 / 65 (0.00%)      occurrences all number 0 1 0 Paraesthesia      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Reproductive system and breast disorders Menorrhagia      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Gastrointestinal disorders Constipation      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Respiratory, thoracic and mediastinal disorders Cough      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Skin and subcutaneous tissue disorders Skin hypopigmentation alternative assessment type: Systematic      subjects affected / exposed 0 / 67 (0.00%) 2 / 65 (3.08%) 4 / 65 (6.15%)      occurrences all number 0 2 4 Skin atrophy alternative assessment type: Systematic      subjects affected / exposed 0 / 67 (0.00%) 2 / 65 (3.08%) 2 / 65 (3.08%)      occurrences all number 0 2 2 Skin and subcutaneous tissue disorders - Other, specify Additional description: Rash - non-specific      subjects affected / exposed 0 / 67 (0.00%) 2 / 65 (3.08%) 0 / 65 (0.00%)      occurrences all number 0 2 0 Psychiatric disorders Anxiety      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 1 / 65 (1.54%)      occurrences all number 0 1 1 Musculoskeletal and connective tissue disorders Arthralgia Additional description: For Best Current Treatment, arthralgia during exercises. For BCT+US-L and BCT+US-T, arthralgia following injection alternative assessment type: Systematic      subjects affected / exposed 2 / 67 (2.99%) 7 / 65 (10.77%) 1 / 65 (1.54%)      occurrences all number 2 7 1 Pain in extremity Additional description: Plantar fasciitis      subjects affected / exposed 0 / 67 (0.00%) 0 / 65 (0.00%) 1 / 65 (1.54%)      occurrences all number 0 0 1 Infections and infestations Infections and infestations - Other, specify      subjects affected / exposed 0 / 67 (0.00%) 1 / 65 (1.54%) 1 / 65 (1.54%)      occurrences all number 0 1 1

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
01 Sep 2016	1) Change to the Reference Safety Information to ensure the latest version of the summary of product characteristics (SmPC) was being used. The new SmPC listed porphyria as an additional contraindication to 1% lidocaine hydrochloride. Addition to exclusion criteria and implementation of urgent safety measure therefore implemented. 2) Due to day-to day variability of osteoarthritis symptoms, a number of potential participants did not meet the eligibility criterion of pain of 4/10 on the day of assessment. In order to address suboptimal recruitment, the inclusion criteria were amended from requiring "Moderate-to-severe hip pain (a score of four or more on a 0–10 numeric rating scale (NRS)) on the day of assessment" to Moderate-to-severe hip pain (a score of four or more on a 0–10 numeric rating scale (NRS)) on average over the last 2 weeks and current hip pain rated as at least 1 out of 10 (on a 0– 10 NRS) on the day of assessment."
18 Oct 2016	This amendment introduced an additional consent form to record consent to screening (eligibility assessment) by potential participants who attended having consulted with hip pain in primary care in the last 12 months and being identified by electronic search of GP practices by the local clinical research network.
06 Feb 2017	Following an MHRA Drug Safety Update (dated 14 December 2016) which highlighted the risk of systemic corticosteroid adverse effects when corticosteroids (including intra-articular triamcinolone) are co-administered to patients taking cobicistat and ritonavir, receiving cobicistat or ritonavir were added to the exclusion criteria via an urgent safety measure.
04 May 2018	1) Revision to required sample size. In response to under-recruitment, the Data Monitoring Committee advised us to explore the robustness of the baseline parameters used to inform the sample size calculation. The original sample size calculation was based on comparisons of participants’ ‘average’ follow-up pain numeric rating scale (NRS) scores, based on a random effects linear repeated-measures model, with a ‘cluster’ size of 4 (denoting 4 follow-up assessments), postulated intra-correlation of 0.7 and baseline-outcome correlation of 0.5. 116 participants per arm (348 total) were required to detect a minimum difference of 1.5 points in mean pain NRS score (anticipated baseline standard deviation (SD) of pain scores=4.5; effect size 0.33) between BCT+US-T and BCT across the 6-month follow-up period (5% 2-tailed significance, 90% power, 15% loss to follow-up). The observed baseline SD was 1.7 (SD for follow up scores 2.5) ie lower than the expected SD of 4.5. The stipulated clinically important difference in the primary outcome of 1.5 in context of this baseline SD would be ‘large’ (effect size> 0.8). It was also noted that the MCID was as low as 1.0 in some studies (equating to a “moderate” effect size 0.4 with respect to SD of 2.5). Hence the revised sample size required 68 participants per arm (204 total) to detect a minimum difference of 1.0 point in mean pain NRS score (SD 2.5; effect size 0.4) between BCT+US-T and BCT alone across the 6-month follow-up period (80% power, 5% 2-tailed significance, repeated measures correlation 0.5, baseline-outcome correlation 0.2, 15% loss to follow-up). 2) Clarification of safety reporting procedures. Addition to the Participant Information Leaflet information about possible visual side-effects of triamcinolone acetonide following a MHRA drug safety update. 3) Owing to lack of capacity and funding, a secondary qualitative objective to explore reasons for non-participation was removed.
06 Nov 2018	Due to limited funding for long-term follow-up and linkage to the National Joint Registry, joint replacement surgery has been removed as a secondary outcome measure from the trial protocol.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None
Online references
http://www.ncbi.nlm.nih.gov/pubmed/30021588

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