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    Clinical Trial Results:
    A Single-Blind Randomised Controlled Pilot trial of Corticosteroid Injection for Shoulder Pain

    Summary
    EudraCT number
    		 2012-000147-27
    Trial protocol
    		 GB  
    Global end of trial date
    31 Mar 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2016
    First version publication date
    14 May 2016
    Other versions
    Summary report(s)
    		 Final analysis published article

    Trial information

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    Trial identification
    Sponsor protocol code
    TH/RCT2/0001
    Additional study identifiers
    ISRCTN number
    		 ISRCTN82357435
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Block 60, Churchill Hospital, Oxford, United Kingdom, OX3 7LJ
    Public contact
    Dr Tim Holt, Nuffield Department of Primary Care Health Sciences University of Oxford, tim.holt@phc.ox.ac.uk
    Scientific contact
    Dr Tim Holt, Nuffield Department of Primary Care Health Sciences University of Oxford, tim.holt@phc.ox.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
    31 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To measure feasibility issues including rates of recruitment and loss to follow up, including withdrawal from a randomised trial of a corticosteroid shoulder injection in patients with rotator cuff tendinopathy or adhesive capsulitis.
    Protection of trial subjects
    Risk assessment took place on 22/6/2016 to identify potential risks associated with the trial and IMP. Prior to recruitment of participants, trial GPs underwent study specific training in the assessment of shoulder pain, including the distinction of rotator cuff tendinopathy from adhesive capsulitis and the distinction of these two conditions and other disorders not relevant to this study. They also received training on the injection technique into the subacromial space employed in this trial. Training was led by an academic orthopedic shoulder surgeon from the Nuffield Orthopaedic Centre at Oxford and is based on the British Elbow and Shoulder Society (BESS) Pathway Guideline for Sub-acromial Pain. The trial GPs also received study specific good clinical practice (GCP) training and training in the study procedures (for example, case report form (CRF) completion, safety reporting) from the Primary Care Clinical Trials Unit. The training took less than 1 day to complete.
    Background therapy
    		 The vials were sourced and labeled by Almac Clinical Services Ltd (Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK) and stored according to the manufactures specifications in the general practice premises.
    Evidence for comparator
    		 Lidocaine is a medicine which is used in neuropathic pain.
    Actual start date of recruitment
    01 Sep 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    30
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between 20/9/2012 and 27/2/2013 from 6 GP practices within the Oxforshire (UK) region

    Pre-assignment
    Screening details
    		 Forty nine people were screened for eligibiity. Nine were excluded due to not eligible (n=7) and declined to participate (n=2)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The trial injection was administered by the GP without disclosing to the participant which treatment they were receiving.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group M
    Arm description
    		 methylprednisolone acetate 40 mg with lidocaine 1% in 1 ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    methylprednisolone acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    Total dose = 40mg (1 single injection)

    Arm title
    		 Group L
    Arm description
    		 lidocaine 1% in 1 ml alone
    Arm type
    		 Active comparator

    Investigational medicinal product name
    lidocaine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    Total dose = 20mg (1 single injection)

    Number of subjects in period 1
    		Group M Group L
    Started
    19
    21
    Completed
    19
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group M
    Reporting group description
    		 methylprednisolone acetate 40 mg with lidocaine 1% in 1 ml

    Reporting group title
    Group L
    Reporting group description
    		 lidocaine 1% in 1 ml alone

    Reporting group values
    		 Group M Group L Total
    Number of subjects
    		 19 21 40
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.5 ( 5.8 ) 56 ( 11.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 15 26
        Male
    		 8 6 14
    Which shoulder is affected
    Units: Subjects
        Right
    		 13 12 25
        Left
    		 6 9 15
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised irrespective of whether the participants received any trial medication

    Subject analysis sets values
    		 ITT
    Number of subjects
    40
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.6 ( 9.4 )
    Gender categorical
    Units: Subjects
        Female
    26
        Male
    14
    Which shoulder is affected
    Units: Subjects
        Right
    25
        Left
    15

    End points

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    End points reporting groups
    Reporting group title
    Group M
    Reporting group description
    		 methylprednisolone acetate 40 mg with lidocaine 1% in 1 ml

    Reporting group title
    Group L
    Reporting group description
    		 lidocaine 1% in 1 ml alone

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients randomised irrespective of whether the participants received any trial medication

    Primary: Attrition rate at 2 weeks

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    End point title
    		 Attrition rate at 2 weeks
    End point description
    Number of questionnaires not returned
    End point type
    Primary
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: subjects
        Yes
    0
    0
        No
    19
    21
    Statistical analysis title
    		 Attrition rate - no formal analysis
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 > 999 [2]
    Method
    		 N/A
    Confidence interval
    Notes
    [1] - This is a pilot study and therefore no formal statistical analysis was performed as stated in the statistical analysis plan
    [2] - This P-value is N/A because there was no formal statistical comparison for this outcome because it's a pilot study

    Primary: Compliance

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    End point title
    		 Compliance
    End point description
    Number adhered to the allocated treatment
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: subjects
        Adhered
    18
    18
    Statistical analysis title
    		 Compliance
    Statistical analysis description
    Compliance with the allocated treatment
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.607
    Method
    		 Fisher exact
    Confidence interval

    Primary: Attrition rate at 4 weeks

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    End point title
    		 Attrition rate at 4 weeks
    End point description
    Number of questionnaires not returned
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    0
    1
        No
    19
    20
    Statistical analysis title
    		 Attrition rate - no formal analysis
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 999 [4]
    Method
    		 N/A
    Confidence interval
    Notes
    [3] - This is a pilot study and therefore no formal statistical analysis was performed as stated in the statistical analysis plan
    [4] - This P-value is N/A because there was no formal statistical comparison for this outcome because it's a pilot study

    Primary: Attrition rate at 12 weeks

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    End point title
    		 Attrition rate at 12 weeks
    End point description
    Number of questionnaire not returned
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    0
    2
        No
    19
    19
    Statistical analysis title
    		 Attrition rate - no formal analysis
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 999 [6]
    Method
    		 N/A
    Confidence interval
    Notes
    [5] - This is a pilot study and therefore no formal statistical analysis was performed as stated in the statistical analysis plan
    [6] - This P-value is N/A because there was no formal statistical comparison for this outcome because it's a pilot study

    Secondary: Change in OSS at 4 weeks

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    End point title
    		 Change in OSS at 4 weeks
    End point description
    Oxford shoulder score
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: point
        arithmetic mean (standard deviation)
    3.9 ( 8.5 )
    6.3 ( 10.1 )
    Statistical analysis title
    		 Change at 4 weeks from baseline
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.1
         upper limit
    		 3.4
    Notes
    [7] - ANCOVA adjusting for baseline score

    Secondary: Change in OSS at 12 weeks

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    End point title
    		 Change in OSS at 12 weeks
    End point description
    Change in Oxford Shoulder Score from baseline
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: points
        arithmetic mean (standard deviation)
    4.2 ( 9.1 )
    8.2 ( 11.3 )
    Statistical analysis title
    		 Change in OSS at 12 weeks from baseline
    Comparison groups
    Group M v Group L
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 3.2

    Secondary: Patient's satisfaction - problem with shoulder now? at 2 weeks

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    End point title
    		 Patient's satisfaction - problem with shoulder now? at 2 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Much worse
    1
    2
        Slightly worse
    3
    7
        No change
    3
    5
        Slightly better
    10
    4
        Much better
    1
    2
        No problem at all
    1
    1
    No statistical analyses for this end point

    Secondary: Patient's satisfaction - problem with shoulder now? at 4 weeks

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    End point title
    		 Patient's satisfaction - problem with shoulder now? at 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    20
    Units: Number of participants
        Much worse
    2
    1
        Slightly worse
    1
    2
        No change
    6
    7
        Slightly better
    4
    5
        Much better
    5
    3
        No problem at all
    1
    2
    No statistical analyses for this end point

    Secondary: Patient's satisfaction - problem with shoulder now? at 12 weeks

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    End point title
    		 Patient's satisfaction - problem with shoulder now? at 12 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    19
    Units: Number of participants
        Much worse
    0
    0
        Slightly worse
    2
    4
        No change
    8
    3
        Slightly better
    3
    3
        Much better
    5
    8
        No problem at all
    1
    1
    No statistical analyses for this end point

    Secondary: Patient's satisfaction with injection - how pleased? 2 weeks

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    End point title
    		 Patient's satisfaction with injection - how pleased? 2 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Very disappointed
    4
    7
        Not very pleased
    5
    9
        Fairly pleased
    9
    3
        Very pleased
    1
    2
    No statistical analyses for this end point

    Secondary: Patient's satisfaction with injection - how pleased? 4 weeks

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    End point title
    		 Patient's satisfaction with injection - how pleased? 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    17
    20
    Units: Number of participants
        Very disappointed
    6
    7
        Not very pleased
    3
    6
        Fairly pleased
    4
    4
        Very pleased
    4
    3
    No statistical analyses for this end point

    Secondary: Patient's satisfaction with injection - how pleased? 12 weeks

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    End point title
    		 Patient's satisfaction with injection - how pleased? 12 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    19
    Units: Number of participants
        Very disappointed
    8
    5
        Not very pleased
    2
    5
        Fairly pleased
    5
    5
        Very pleased
    4
    4
    No statistical analyses for this end point

    Secondary: Patient's satisfaction - still choose the injection? 2 weeks

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    End point title
    		 Patient's satisfaction - still choose the injection? 2 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        No
    3
    7
        Yes
    14
    10
        Not sure
    2
    4
    No statistical analyses for this end point

    Secondary: Patient's satisfaction - still choose the injection? 4 weeks

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    End point title
    		 Patient's satisfaction - still choose the injection? 4 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    20
    Units: Number of participants
        No
    1
    4
        Yes
    14
    11
        Not sure
    4
    5
    No statistical analyses for this end point

    Secondary: Patient's satisfaction - still choose the injection? 12 weeks

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    End point title
    		 Patient's satisfaction - still choose the injection? 12 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    19
    Units: Number of participants
        No
    4
    4
        Yes
    12
    10
        Not sure
    3
    5
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - Pain killers: 2 weeks

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    End point title
    		 Received other treatment - Pain killers: 2 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    18
    21
    Units: Number of participants
        Yes
    8
    11
        No
    10
    4
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - Pain killers: 4 weeks

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    End point title
    		 Received other treatment - Pain killers: 4 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    20
    Units: Number of participants
        Yes
    7
    11
        No
    12
    9
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - Pain killers: 12 weeks

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    End point title
    		 Received other treatment - Pain killers: 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    17
    19
    Units: Number of participants
        Yes
    7
    11
        No
    10
    8
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - anti-infammatory medication: 2 weeks

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    End point title
    		 Received other treatment - anti-infammatory medication: 2 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    18
    20
    Units: Number of participants
        Yes
    5
    10
        No
    13
    10
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - anti-infammatory medication: 4 weeks

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    End point title
    		 Received other treatment - anti-infammatory medication: 4 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    17
    19
    Units: Number of participants
        Yes
    4
    7
        No
    13
    12
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - anti-infammatory medication: 12 weeks

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    End point title
    		 Received other treatment - anti-infammatory medication: 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    16
    Units: Number of participants
        Yes
    6
    10
        No
    13
    6
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - physiotherapy: 2 weeks

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    End point title
    		 Received other treatment - physiotherapy: 2 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    2 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    17
    20
    Units: Number of participants
        Yes
    0
    1
        No
    17
    19
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - physiotherapy: 4 weeks

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    End point title
    		 Received other treatment - physiotherapy: 4 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    4 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    16
    19
    Units: Number of participants
        Yes
    1
    3
        No
    15
    16
    No statistical analyses for this end point

    Other pre-specified: Received other treatment - physiotherapy: 12 weeks

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    End point title
    		 Received other treatment - physiotherapy: 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    18
    18
    Units: Number of participants
        Yes
    1
    6
        No
    17
    12
    No statistical analyses for this end point

    Other pre-specified: Received rescue steroid injection

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    End point title
    		 Received rescue steroid injection
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    1
    3
    No statistical analyses for this end point

    Other pre-specified: Received physiotherapy in 12 weeks

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    End point title
    		 Received physiotherapy in 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    3
    3
    No statistical analyses for this end point

    Other pre-specified: Received prescribed analgesia in 12 weeks

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    End point title
    		 Received prescribed analgesia in 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    2
    2
    No statistical analyses for this end point

    Other pre-specified: Received NSAID in 12 weeks

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    End point title
    		 Received NSAID in 12 weeks
    End point description
    End point type
    Other pre-specified
    End point timeframe
    12 weeks
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    1
    6
    No statistical analyses for this end point

    Other pre-specified: Treatment allocation blinding assessment

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    End point title
    		 Treatment allocation blinding assessment
    End point description
    End point type
    Other pre-specified
    End point timeframe
    At the time of injection
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        100%
    13
    15
        89-99%
    6
    6
    No statistical analyses for this end point

    Other pre-specified: Serious adverse event

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    End point title
    		 Serious adverse event
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Throughout the trial
    End point values
    		 Group M Group L
    Number of subjects analysed
    19
    21
    Units: Number of participants
        Yes
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events reporting occurs through the entire duration of the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Both methylprednisolone acetate and lidocaine hydrochloride are commonly used medications in a primary care setting, have well defined safety profiles and are being used for authorised indications. As a result of this no non-serious adverse events will be recorded in this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Nov 2012
    Substantial amendment with regards to putting up posters in the waiting rooms of the GP surgeries that are participating in the trial. The posters will ask patients if they have shoulder pain and if they match certain requirements of the inclusion criteria. The patients will be asked the speak with the trial GP at the practice for further information. In addition, to have patient leaflets in the reception areas of the GP surgeries. The leaflets will detail information about the trial and will ask the patient to contact the trial GP at the practice for further information. It is anticipated that these documents will help aid the practices in recruiting participants.

    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 reported
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