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    Clinical Trial Results:
    The clinical and cost effectiveness of a steroid injection versus a night splint for Carpal Tunnel Syndrome: a pragmatic randomised trial in primary care (INSTinCTS)

    Summary
    EudraCT number
    		 2013-001435-48
    Trial protocol
    		 GB  
    Global end of trial date
    26 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2020
    First version publication date
    13 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    464/11
    Additional study identifiers
    ISRCTN number
    		 ISRCTN09392969
    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
    Clinical Studies Co-ordinator, Keele Primary Care Musculoskeletal Trials Unit (Keele CTU), 0044 01782 733909, e.skinner@keele.ac.uk
    Scientific contact
    Clinical Studies Co-ordinator, Keele Primary Care Musculoskeletal Trials Unit (Keele CTU), 0044 01782 733909, e.skinner@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
    20 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care.
    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
    		 The most frequently reported and readily available treatments for carpal tunnel syndrome in primary care are splinting, anti-inflammatory medication and local corticosteroid injection. Systematic reviews (including Cochrane reviews) of nonsurgical conservative treatments have assessed local corticosteroid injections, oral steroid medication and splinting. Both night splinting and steroid injection lead to greater improvement in symptoms in the short-term over no treatment or placebo injection although evidence of longer benefit was unclear. Review authors concluded that many of the trials included in these reviews had a high risk of bias and more robust trials are needed to compare treatments and ascertain the duration of benefit. A direct comparison between the effects of steroid injection and splinting has been made in two small trials, neither of which were carried out in a primary care setting where most people with carpal tunnel syndrome are managed.
    Actual start date of recruitment
    17 Apr 2014
    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: 234
    Worldwide total number of subjects
    234
    EEA total number of subjects
    234
    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)
    174
    From 65 to 84 years
    56
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients were recruited from 25 General Practices and community musculoskeletal clinics between 17/04/2014 and 31/12/2016

    Pre-assignment
    Screening details
    		 Patients with a positive CTS diagnosis were assessed for eligibility by the GP/clinician based on the inclusion/exclusion criteria. Patients who were interested in trial participation were then seen by appropriate member of the clinical team who explained the trial in full, and were asked to provide written informed consent.

    Pre-assignment period milestones
    Number of subjects started
    		 234
    Number of subjects completed
    		 234

    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 the allocation of treatment arm. The research nurses who conducted minimal data collection and statisticians were blind to allocation. Analysis of the primary outcome was conducted blind to arm allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Steroid injection
    Arm description
    		 One injection of 20mg methylprednisolone acetate to inflitrate the carpal tunnel
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Methylprednisolone acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    One injection of 20mg methylprednisolone acetate (as 20mg of depo-medrone from 40mg/mL) via a disposable needle (23G or 25G) and syringe which was inserted at the wrist between the proximal and distal wrist crease to infiltrate the carpal tunnel.

    Arm title
    		 Splint
    Arm description
    		 Participants received a beta wrist brace which immobilised the wrist in a neutral or slightly extended position intended to reduce pressure within the carpal tunnel, to wear at night for 6 weeks.
    Arm type
    		 Wrist splint

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Analysis was performed blind to treatment allocation. Data collection was self-reported but a blind assessor collected data from questionnaire non-responders.
    Number of subjects in period 1
    		Steroid injection Splint
    Started
    116
    118
    Baseline
    113
    117
    6 weeks follow-up
    108
    109
    6 months follow-up
    96
    97
    12 months follow-up
    87
    88
    24 months follow-up
    78
    81
    Completed
    78
    81
    Not completed
    38
    37
         Consent withdrawn by subject
    7
    9
         Lost to follow-up
    31
    28

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Steroid injection
    Reporting group description
    		 One injection of 20mg methylprednisolone acetate to inflitrate the carpal tunnel

    Reporting group title
    Splint
    Reporting group description
    		 Participants received a beta wrist brace which immobilised the wrist in a neutral or slightly extended position intended to reduce pressure within the carpal tunnel, to wear at night for 6 weeks.

    Reporting group values
    		 Steroid injection Splint Total
    Number of subjects
    		 116 118 234
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 85 89 174
        From 65-84 years
    		 28 28 56
        85 years and over
    		 3 1 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.6 ( 17.0 ) 52.2 ( 14.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 73 81 154
        Male
    		 43 37 80
    First time diagnosed with CTS
    CTS: Carpal Tunnel Syndrome
    Units: Subjects
        Yes
    		 97 102 199
        No
    		 16 15 31
        Missing
    		 3 1 4
    Number of times previously had CTS
    CTS: Carpal Tunnel Syndrome
    Units: Subjects
        N/A
    		 97 102 199
        One
    		 11 8 19
        Two
    		 1 1 2
        Three
    		 0 0 0
        More than three
    		 3 4 7
        Missing
    		 4 3 7
    Hand or wrist previously affected by CTS
    CTS: Carpal Tunnel Syndrome
    Units: Subjects
        N/A
    		 97 102 199
        Right
    		 6 3 9
        Left
    		 1 2 3
        Both
    		 8 9 17
        Missing
    		 4 2 6
    Steroid injection into a joint other than wrist if previously had CTS
    CTS: Carpal Tunnel Syndrome
    Units: Subjects
        N/A
    		 97 102 199
        Yes
    		 9 9 18
        No
    		 7 6 13
        Missing
    		 3 1 4
    Usefulness of injection into other joint if previously had CTS
    CTS: Carpal Tunnel Syndrome
    Units: Subjects
        N/A
    		 104 108 212
        Of great help
    		 7 7 14
        Of some help
    		 1 1 2
        Of little help
    		 0 0 0
        Of no help
    		 1 1 2
        Missing
    		 3 1 4
    Which problematic hand or wrist
    Units: Subjects
        Right
    		 36 37 73
        Left
    		 19 20 39
        Both
    		 57 59 116
        Missing
    		 4 2 6
    If both hands problematic, which hand was worse
    Units: Subjects
        N/A
    		 55 57 112
        Right
    		 25 24 49
        Left
    		 13 19 32
        No difference
    		 7 3 10
        Missing
    		 16 15 31
    Dominant hand
    Units: Subjects
        Right
    		 99 99 198
        Left
    		 12 16 28
        Missing
    		 5 3 8
    Duration of hand or wrist problems
    Units: Subjects
        <3 months
    		 19 17 36
        3-6 months
    		 37 33 70
        6 months-1 year
    		 22 27 49
        >1 year
    		 34 39 73
        Missing
    		 4 2 6
    How did hand or wrist problems start
    Units: Subjects
        Suddenly
    		 33 17 50
        Gradually
    		 79 99 178
        Missing
    		 4 2 6
    Particular position causes hand or wrist problems
    Units: Subjects
        Yes
    		 50 62 112
        No
    		 62 54 116
        Missing
    		 4 2 6
    Currently taking pain relief
    Units: Subjects
        Yes
    		 36 34 70
        No
    		 77 83 160
        Missing
    		 3 1 4
    Number of times a day taking pain relief
    Units: Subjects
        N/A
    		 77 83 160
        One
    		 7 8 15
        Two
    		 13 5 18
        Three
    		 5 5 10
        Four
    		 3 5 8
        Five
    		 0 1 1
        Missing
    		 11 11 22
    Number of days per week taking pain relief
    Units: Subjects
        N/A
    		 77 83 160
        One
    		 0 0 0
        Two
    		 1 4 5
        Three
    		 3 0 3
        Four
    		 1 0 1
        Five
    		 2 2 4
        Six
    		 0 0 0
        Seven
    		 14 7 21
        Missing
    		 18 22 40
    Number of weeks in a month taking pain relief
    Units: Subjects
        N/A
    		 77 83 160
        One
    		 1 0 1
        Two
    		 2 1 3
        Three
    		 1 0 1
        Four
    		 17 9 26
        Missing
    		 18 25 43
    In a current paid job
    Units: Subjects
        Yes
    		 58 74 132
        No
    		 55 42 97
        Missing
    		 3 2 5
    Typical weekly working hours
    Units: Subjects
        N/A
    		 55 42 97
        Full time
    		 39 47 86
        Part time
    		 18 27 45
        Missing
    		 4 2 6
    Describes current situation in respect of your job
    Units: Subjects
        N/A
    		 55 42 97
        Doing my usual job
    		 50 62 112
        On paid annual leave/holiday
    		 2 1 3
        Working fewer hours
    		 1 2 3
        Doing lighter duties
    		 1 6 7
        On paid sick leave
    		 3 3 6
        On unpaid sick leave
    		 0 0 0
        Missing
    		 4 2 6
    If not doing usual job/annual leave, is this due to hand or wrist problems
    Units: Subjects
        N/A
    		 105 105 210
        Yes
    		 2 4 6
        No
    		 3 6 9
        Missing
    		 6 3 9
    Taken time off work during the last 6 months for your hand or wrist problem
    Units: Subjects
        N/A
    		 55 42 97
        Yes
    		 8 5 13
        No
    		 49 69 118
        Missing
    		 4 2 6
    I feel my welfare is important to my employer
    Units: Subjects
        N/A
    		 104 111 215
        Strongly disagree
    		 0 0 0
        Disagree
    		 0 0 0
        Agree
    		 4 3 7
        Strongly agree
    		 4 2 6
        Missing
    		 4 2 6
    Which treatment would you prefer
    Units: Subjects
        Strongly prefer wrist injection
    		 13 13 26
        Somewhat prefer wrist injection
    		 11 21 32
        No preference
    		 65 60 125
        Somewhat prefer night splints
    		 12 8 20
        Strongly prefer night splints
    		 6 10 16
        Missing
    		 9 6 15
    If you received wrist injection would you expect your symptoms to improve
    Units: Subjects
        Yes
    		 69 70 139
        No
    		 0 2 2
        Not sure
    		 39 41 80
        Missing
    		 8 5 13
    If you received night splint would you expect your symptoms to improve
    Units: Subjects
        Yes
    		 46 40 86
        No
    		 3 4 7
        Not sure
    		 58 69 127
        Missing
    		 9 5 14
    My hand or wrist problem will last for a long time
    Units: Subjects
        Strongly disagree
    		 3 3 6
        Disagree
    		 7 8 15
        Neither agree nor disagree
    		 45 51 96
        Agree
    		 44 42 86
        Strongly agree
    		 14 12 26
        Missing
    		 3 2 5
    My hand or wrist problem has major consequences on my life
    Units: Subjects
        Strongly disagree
    		 4 10 14
        Disagree
    		 19 22 41
        Neither agree nor disagree
    		 26 30 56
        Agree
    		 41 37 78
        Strongly agree
    		 23 17 40
        Missing
    		 3 2 5
    There is a lot that I can do to control my hand or wrist problems
    Units: Subjects
        Strongly disagree
    		 12 9 21
        Disagree
    		 21 31 52
        Neither agree nor disagree
    		 48 42 90
        Agree
    		 30 32 62
        Strongly agree
    		 2 2 4
        Missing
    		 3 2 5
    What I can do determines whether my hand or wrist problem gets better or worse
    Units: Subjects
        Strongly disagree
    		 4 4 8
        Disagree
    		 11 14 25
        Neither agree nor disagree
    		 40 32 72
        Agree
    		 49 57 106
        Strongly agree
    		 9 9 18
        Missing
    		 3 2 5
    Treatment can control my hand or wrist problem
    Units: Subjects
        Strongly disagree
    		 0 0 0
        Disagree
    		 3 0 3
        Neither agree nor disagree
    		 20 35 55
        Agree
    		 74 71 145
        Strongly agree
    		 16 9 25
        Missing
    		 3 3 6
    My hand or wrist problem affects me emotionally
    Units: Subjects
        Strongly disagree
    		 10 18 28
        Disagree
    		 17 19 36
        Neither agree nor disagree
    		 17 21 38
        Agree
    		 40 45 85
        Strongly agree
    		 29 13 42
        Missing
    		 3 2 5
    Been bothered by feeling down, depressed or hopeless
    Units: Subjects
        Yes
    		 47 39 86
        No
    		 66 78 144
        Missing
    		 3 1 4
    Been bothered by little interest or pleasure in doing things
    Units: Subjects
        Yes
    		 39 33 72
        No
    		 74 83 157
        Missing
    		 3 2 5
    Diagnosed with hypothyroidism
    Units: Subjects
        Yes
    		 5 9 14
        No
    		 108 107 215
        Missing
    		 3 2 5
    Diagnosed with diabetes
    Units: Subjects
        Yes
    		 13 8 21
        No
    		 99 109 208
        Missing
    		 4 1 5
    Any other conditions affecting neck, shoulders or elbows
    Units: Subjects
        Yes
    		 45 28 73
        No
    		 68 88 156
        Missing
    		 3 2 5
    Had pain anywhere else
    Units: Subjects
        Yes
    		 74 72 146
        No
    		 39 45 84
        Missing
    		 3 1 4
    Last time you were free of pain
    Units: Subjects
        <3 months ago
    		 22 20 42
        3-6 months ago
    		 13 19 32
        6 months-1 year
    		 9 23 32
        1-3 years ago
    		 38 23 61
        >3 years ago
    		 31 32 63
        Missing
    		 3 1 4
    On average how often do you drink alcohol
    Units: Subjects
        Daily or most days
    		 11 11 22
        Once or twice a week
    		 38 45 83
        Once or twice a month
    		 25 22 47
        One or twice a year
    		 16 18 34
        Never
    		 23 21 44
        Missing
    		 3 1 4
    What is your current smoking status
    Units: Subjects
        Never smoked
    		 55 55 110
        Previously smoked
    		 39 48 87
        Current smoker
    		 19 13 32
        Missing
    		 3 2 5
    Insomnia due to hand or wrist problems
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Based on multiply imputed data
    Units: Subjects
        No
    		 46 58 104
        Yes
    		 70 60 130
    Treatment for previous CTS: steroid injection
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 16 12 28
        Yes
    		 3 4 7
    Treatment for previous CTS: Wrist splint
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 12 12 24
        Yes
    		 7 4 11
    Treatment for previous CTS: carpal tunnel decompression
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 16 14 30
        Yes
    		 3 2 5
    Treatment for previous CTS: ultrasound
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 18 15 33
        Yes
    		 1 1 2
    Treatment for previous CTS: exercises
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 19 16 35
        Yes
    		 0 0 0
    Treatment for previous CTS: vitamin supplements
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 19 15 34
        Yes
    		 0 1 1
    Treatment for previous CTS: changes in workplace
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 19 16 35
        Yes
    		 0 0 0
    Treatment for previous CTS: other
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 18 16 34
        Yes
    		 1 0 1
    Treatment for previous CTS: none
    Units: Subjects
        Not applicable
    		 97 102 199
        No
    		 14 8 22
        Yes
    		 5 8 13
    If not in a current paid job, describe current position: retired
    Units: Subjects
        Not applicable
    		 58 74 132
        No
    		 20 15 35
        Yes
    		 38 29 67
    If not in a current paid job, describe current position: student
    Units: Subjects
        Not applicable
    		 58 74 132
        No
    		 55 43 98
        Yes
    		 3 1 4
    If not in a current paid job, describe current position: looking after children/home
    Units: Subjects
        Not applicable
    		 58 74 132
        No
    		 46 35 81
        Yes
    		 12 9 21
    If not in a current paid job, describe current position: unemployed
    Units: Subjects
        Not applicable
    		 58 74 132
        No
    		 55 37 92
        Yes
    		 3 7 10
    If not in a current paid job, describe current position: voluntary worker
    Units: Subjects
        Not applicable
    		 58 74 132
        No
    		 56 44 100
        Yes
    		 2 0 2
    To what extent have hand or wrist problems affected your performance at work over the past month
    0-10 scale; 0=not at all, 10=unable to do job
    Units: 0-10 scale
        arithmetic mean (standard deviation)
    		 3.8 ( 3.0 ) 4.2 ( 2.9 ) -
    Body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.2 ( 7.6 ) 30.5 ( 7.5 ) -
    BCTQ symptom severity and functional limitations
    Higher scores indicate more symptom severity and functional limitations. Based on multiply imputed data. BCTQ: Boston carpal tunnel questionnaire.
    Units: 1-5
        arithmetic mean (standard deviation)
    		 2.69 ( 0.70 ) 2.65 ( 0.62 ) -
    BCTQ symptom severity subscale
    Higher scores indicate more severe symptoms. Based on multiply imputed data. BCTQ: Boston carpal tunnel questionnaire.
    Units: 1-5
        arithmetic mean (standard deviation)
    		 2.96 ( 0.66 ) 2.91 ( 0.61 ) -
    BCTQ functional limitations subscale
    Higher scores indicate more severe functional impairment. Based on multiply imputed data. BCTQ: Boston carpal tunnel questionnaire.
    Units: 1-5
        arithmetic mean (standard deviation)
    		 2.32 ( 0.92 ) 2.28 ( 0.84 ) -
    Hand-wrist pain intensity
    Higher scores indicate more pain
    Units: 0-10
        arithmetic mean (standard deviation)
    		 6.33 ( 2.05 ) 6.12 ( 2.21 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Steroid injection
    Reporting group description
    		 One injection of 20mg methylprednisolone acetate to inflitrate the carpal tunnel

    Reporting group title
    Splint
    Reporting group description
    		 Participants received a beta wrist brace which immobilised the wrist in a neutral or slightly extended position intended to reduce pressure within the carpal tunnel, to wear at night for 6 weeks.

    Primary: BCTQ symptom severity and functional limitations 6 weeks

    		 Close Top of page
    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks
    End point description
    Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    2.02 ( 0.81 )
    2.29 ( 0.75 )
    Statistical analysis title
    		 Multiple imputation at 6 weeks
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.16

    Secondary: BCTQ symptom severity subscale 6 weeks

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    End point title
    		 BCTQ symptom severity subscale 6 weeks
    End point description
    Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    2.12 ( 0.84 )
    2.43 ( 0.76 )
    Statistical analysis title
    		 Multiple imputation at 6 weeks
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 -0.17

    Secondary: BCTQ functional limitations subscale 6 weeks

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    End point title
    		 BCTQ functional limitations subscale 6 weeks
    End point description
    Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    1.88 ( 0.88 )
    2.09 ( 0.86 )
    Statistical analysis title
    		 Multiple imputation at 6 weeks
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 -0.09

    Secondary: Hand-wrist pain intensity 6 weeks

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    End point title
    		 Hand-wrist pain intensity 6 weeks
    End point description
    Comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain).
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-10
        arithmetic mean (standard deviation)
    3.42 ( 2.77 )
    4.28 ( 2.73 )
    Statistical analysis title
    		 Multiple imputation at 6 weeks
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.64
         upper limit
    		 -0.3

    Secondary: Insomnia due to hand-wrist problems 6 weeks

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    End point title
    		 Insomnia due to hand-wrist problems 6 weeks
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    83
    73
        Yes
    33
    45
    Statistical analysis title
    		 Multiple imputation at 6 weeks
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 weeks. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.87

    Secondary: Referral to surgery at 6 weeks

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    End point title
    		 Referral to surgery at 6 weeks
    End point description
    Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was planned at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of `yes' counts
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    112
    113
        Yes
    4
    5
    No statistical analyses for this end point

    Secondary: Surgery 6 weeks

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    End point title
    		 Surgery 6 weeks
    End point description
    Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was planned at 6 weeks. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of `yes' counts.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    114
    116
        Yes
    2
    2
    No statistical analyses for this end point

    Secondary: BCTQ symptom severity and functional limitations 6 months

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    End point title
    		 BCTQ symptom severity and functional limitations 6 months
    End point description
    Comparison of overall BCTQ between treatment groups at 6 months follow-up (higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    2.15 ( 0.79 )
    2.06 ( 0.73 )
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.23

    Secondary: BCTQ symptom severity subscale 6 months

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    End point title
    		 BCTQ symptom severity subscale 6 months
    End point description
    Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    2.33 ( 0.86 )
    2.18 ( 0.75 )
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.33

    Secondary: BCTQ functional limitations subscale 6 months

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    End point title
    		 BCTQ functional limitations subscale 6 months
    End point description
    Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 1-5
        arithmetic mean (standard deviation)
    1.91 ( 0.84 )
    1.89 ( 0.84 )
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.96
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.175
         upper limit
    		 0.166

    Secondary: Hand-wrist pain intensity 6 months

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    End point title
    		 Hand-wrist pain intensity 6 months
    End point description
    Comparison of pain scores between treatment groups at 6 months follow-up (higher score indicates more pain).
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-10
        arithmetic mean (standard deviation)
    4.32 ( 3.26 )
    3.46 ( 3.01 )
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.055
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 1.59

    Secondary: Insomnia due to hand-wrist problems 6 months

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    End point title
    		 Insomnia due to hand-wrist problems 6 months
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    79
    86
        Yes
    37
    32
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.76
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 2.2

    Secondary: Referral to surgery 6 months

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    End point title
    		 Referral to surgery 6 months
    End point description
    Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    94
    104
        Yes
    22
    14
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 3.77

    Secondary: Surgery 6 months

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    End point title
    		 Surgery 6 months
    End point description
    Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    99
    105
        Yes
    17
    13
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between the treatment groups were adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 3.98

    Secondary: Herbal remedies and vitamin use 6 months

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    End point title
    		 Herbal remedies and vitamin use 6 months
    End point description
    Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    109
    111
        Yes
    7
    7
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 7.34

    Secondary: Over the counter pain medication 6 months

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    End point title
    		 Over the counter pain medication 6 months
    End point description
    Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    82
    88
        Yes
    34
    30
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 3.18

    Secondary: Prescribed pain medication 6 months

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    End point title
    		 Prescribed pain medication 6 months
    End point description
    Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 2 categories
        No
    96
    106
        Yes
    20
    12
    Statistical analysis title
    		 Multiple imputation at 6 months
    Statistical analysis description
    Multiple imputation for missing data was performed at 6 months. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 5.66

    Secondary: BCTQ symptom severity and functional limitations over 24 months: 6 weeks

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    End point title
    		 BCTQ symptom severity and functional limitations over 24 months: 6 weeks
    End point description
    Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more severe symptoms and functional impairment). Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    95
    102
    Units: 1-5
        arithmetic mean (standard deviation)
    1.95 ( 0.82 )
    2.30 ( 0.77 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 -0.14

    Secondary: BCTQ symptom severity and functional limitations over 24 months: 6 months

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    End point title
    		 BCTQ symptom severity and functional limitations over 24 months: 6 months
    End point description
    Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more severe symptoms and functional impairment). Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    83
    92
    Units: 1-5
        arithmetic mean (standard deviation)
    2.08 ( 0.79 )
    2.04 ( 0.72 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Splint v Steroid injection
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.24

    Secondary: BCTQ symptom severity and functional limitations over 24 months: 12 months

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    End point title
    		 BCTQ symptom severity and functional limitations over 24 months: 12 months
    End point description
    Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    78
    78
    Units: 1-5
        arithmetic mean (standard deviation)
    1.98 ( 0.88 )
    2.05 ( 0.80 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.12

    Secondary: BCTQ symptom severity and functional limitations over 24 months: 24 months

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    End point title
    		 BCTQ symptom severity and functional limitations over 24 months: 24 months
    End point description
    Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more severe symptoms and functional impairment). Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    70
    73
    Units: 1-5
        arithmetic mean (standard deviation)
    1.79 ( 0.79 )
    1.73 ( 0.76 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.28

    Secondary: Hand-wrist pain intensity over 24 months: 6 weeks

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    End point title
    		 Hand-wrist pain intensity over 24 months: 6 weeks
    End point description
    Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more pain). Results are presented at 6 weeks.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    105
    106
    Units: 0-10
        arithmetic mean (standard deviation)
    3.33 ( 2.67 )
    4.28 ( 2.62 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.72
         upper limit
    		 -0.24

    Secondary: Hand-wrist pain intensity over 24 months: 6 months

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    End point title
    		 Hand-wrist pain intensity over 24 months: 6 months
    End point description
    Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more pain). Results are presented at 6 months.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    92
    94
    Units: 0-10
        arithmetic mean (standard deviation)
    4.11 ( 3.01 )
    3.29 ( 2.74 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.058
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 1.54

    Secondary: Hand-wrist pain intensity over 24 months: 12 months

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    End point title
    		 Hand-wrist pain intensity over 24 months: 12 months
    End point description
    Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more pain). Results are presented at 12 months.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    83
    85
    Units: 0-10
        arithmetic mean (standard deviation)
    3.17 ( 2.93 )
    3.14 ( 2.74 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.95
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 0.85

    Secondary: Hand-wrist pain intensity over 24 months: 24 months

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    End point title
    		 Hand-wrist pain intensity over 24 months: 24 months
    End point description
    Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up) (higher score indicates more pain). Results were presented at 24 months.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    75
    77
    Units: 0-10
        arithmetic mean (standard deviation)
    2.81 ( 3.19 )
    2.40 ( 2.83 )
    Statistical analysis title
    		 Available case analysis
    Statistical analysis description
    Available case analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms. An interaction term was fitted between treatment and follow-up time point to estimate treatment effect at each time point.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 1.26

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (CC)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (CC)
    End point description
    Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    95
    102
    Units: 1-5
        arithmetic mean (standard deviation)
    1.95 ( 0.82 )
    2.29 ( 0.77 )
    Statistical analysis title
    		 Complete case analysis at 6 weeks
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.19

    Secondary: BCTQ symptom severity subscale 6 weeks (CC)

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    End point title
    		 BCTQ symptom severity subscale 6 weeks (CC)
    End point description
    Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    104
    104
    Units: 1-5
        arithmetic mean (standard deviation)
    2.07 ( 0.83 )
    2.44 ( 0.78 )
    Statistical analysis title
    		 Complete case analysis at 6 weeks
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.21

    Secondary: BCTQ functional limitations subscale 6 weeks (CC)

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    End point title
    		 BCTQ functional limitations subscale 6 weeks (CC)
    End point description
    Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    96
    105
    Units: 1-5
        arithmetic mean (standard deviation)
    1.86 ( 0.91 )
    2.10 ( 0.86 )
    Statistical analysis title
    		 Complete case analysis at 6 weeks
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 -0.08

    Secondary: Hand-wrist pain intensity 6 weeks (CC)

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    End point title
    		 Hand-wrist pain intensity 6 weeks (CC)
    End point description
    Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    105
    106
    Units: 0-10
        arithmetic mean (standard deviation)
    3.33 ( 2.67 )
    4.28 ( 2.62 )
    Statistical analysis title
    		 Complete case analysis at 6 weeks
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.72
         upper limit
    		 -0.38

    Secondary: Insomnia due to hand-wrist problems 6 weeks (CC)

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    End point title
    		 Insomnia due to hand-wrist problems 6 weeks (CC)
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    97
    96
    Units: 2 categories
        No
    75
    62
        Yes
    22
    34
    Statistical analysis title
    		 Complete case analysis at 6 weeks
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.74

    Secondary: BCTQ symptom severity and functional limitations 6 months (CC)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 months (CC)
    End point description
    Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    83
    92
    Units: 1-5
        arithmetic mean (standard deviation)
    2.08 ( 0.79 )
    2.04 ( 0.72 )
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Splint v Steroid injection
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.24

    Secondary: BCTQ symptom severity 6 months (CC)

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    End point title
    		 BCTQ symptom severity 6 months (CC)
    End point description
    Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    88
    94
    Units: 1-5
        arithmetic mean (standard deviation)
    2.29 ( 0.87 )
    2.16 ( 0.74 )
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.35

    Secondary: BCTQ functional limitations subscale 6 months (CC)

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    End point title
    		 BCTQ functional limitations subscale 6 months (CC)
    End point description
    Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    85
    93
    Units: 1-5
        arithmetic mean (standard deviation)
    1.85 ( 0.84 )
    1.88 ( 0.82 )
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.93
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.18

    Secondary: Hand-wrist pain intensity 6 months (CC)

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    End point title
    		 Hand-wrist pain intensity 6 months (CC)
    End point description
    Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (higher score indicates more pain) on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    92
    94
    Units: 1-5
        arithmetic mean (standard deviation)
    4.11 ( 3.01 )
    3.29 ( 2.74 )
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 1.61

    Secondary: Insomnia due to hand-wrist problems 6 months (CC)

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    End point title
    		 Insomnia due to hand-wrist problems 6 months (CC)
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    80
    86
    Units: 2 categories
        No
    60
    68
        Yes
    20
    18
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 2.88

    Secondary: Referral to surgery 6 months (CC)

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    End point title
    		 Referral to surgery 6 months (CC)
    End point description
    Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Sensitivity analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    96
    93
    Units: 2 categories
        No
    80
    82
        Yes
    16
    11
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 3.34

    Secondary: Herbal remedies and vitamin use 6 months (CC)

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    End point title
    		 Herbal remedies and vitamin use 6 months (CC)
    End point description
    Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Complete case analysis as a sensitivity analysis was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of `yes' counts.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    80
    83
    Units: 2 categories
        No
    78
    81
        Yes
    2
    2
    No statistical analyses for this end point

    Secondary: Over the counter pain medication 6 months (CC)

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    End point title
    		 Over the counter pain medication 6 months (CC)
    End point description
    Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Sensitivity analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    80
    83
    Units: 2 categories
        No
    64
    66
        Yes
    16
    17
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 3.06

    Secondary: Prescribed pain medication 6 months (CC)

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    End point title
    		 Prescribed pain medication 6 months (CC)
    End point description
    Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Sensitivity analysis for comparison of the odds of pain medication use between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    82
    86
    Units: 2 categories
        No
    70
    79
        Yes
    12
    7
    Statistical analysis title
    		 Complete case analysis at 6 months
    Statistical analysis description
    Complete case analysis as a sensitivity analysis was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 5.78

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (PR)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (PR)
    End point description
    Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    94
    85
    Units: 1-5
        arithmetic mean (standard deviation)
    1.96 ( 0.84 )
    2.28 ( 0.72 )
    Statistical analysis title
    		 Per protocol analysis at 6 weeks
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Splint v Steroid injection
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.18

    Secondary: BCTQ symptom severity 6 weeks (PR)

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    End point title
    		 BCTQ symptom severity 6 weeks (PR)
    End point description
    Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    102
    86
    Units: 1-5
        arithmetic mean (standard deviation)
    2.07 ( 0.83 )
    2.44 ( 0.74 )
    Statistical analysis title
    		 Per protocol analysis at 6 weeks
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.19

    Secondary: BCTQ functional limitations subscale 6 weeks (PR)

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    End point title
    		 BCTQ functional limitations subscale 6 weeks (PR)
    End point description
    Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    95
    87
    Units: 1-5
        arithmetic mean (standard deviation)
    1.88 ( 0.94 )
    2.06 ( 0.80 )
    Statistical analysis title
    		 Per protocol analysis at 6 weeks
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.09

    Secondary: Hand-wrist pain intensity 6 weeks (PR)

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    End point title
    		 Hand-wrist pain intensity 6 weeks (PR)
    End point description
    Per protocol analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (higher score indicates more pain) on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    103
    87
    Units: 1-5
        arithmetic mean (standard deviation)
    3.33 ( 2.67 )
    4.44 ( 2.50 )
    Statistical analysis title
    		 Per protocol analysis at 6 weeks
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 -0.48

    Secondary: Insomnia due to hand-wrist problems 6 weeks (PR)

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    End point title
    		 Insomnia due to hand-wrist problems 6 weeks (PR)
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 weeks follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    95
    87
    Units: 2 categories
        No
    74
    57
        Yes
    21
    30
    Statistical analysis title
    		 Per protocol analysis at 6 weeks
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.74

    Secondary: BCTQ symptom severity and functional limitations 6 months (PR)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 months (PR)
    End point description
    Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    83
    76
    Units: 1-5
        arithmetic mean (standard deviation)
    2.09 ( 0.79 )
    2.02 ( 0.69 )
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.63
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.25

    Secondary: BCTQ symptom severity 6 months (PR)

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    End point title
    		 BCTQ symptom severity 6 months (PR)
    End point description
    Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    88
    78
    Units: 1-5
        arithmetic mean (standard deviation)
    2.28 ( 0.86 )
    2.15 ( 0.73 )
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.28
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.35

    Secondary: BCTQ functional limitations subscale 6 months (PR)

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    End point title
    		 BCTQ functional limitations subscale 6 months (PR)
    End point description
    Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    85
    77
    Units: 1-5
        arithmetic mean (standard deviation)
    1.89 ( 0.87 )
    1.84 ( 0.77 )
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    162
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.2

    Secondary: Hand-wrist pain intensity 6 months (PR)

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    End point title
    		 Hand-wrist pain intensity 6 months (PR)
    End point description
    Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (higher score indicates more pain) on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    92
    78
    Units: 0-10
        arithmetic mean (standard deviation)
    4.11 ( 2.99 )
    3.38 ( 2.79 )
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 1.59

    Secondary: Insomnia due to hand-wrist problems 6 months (PR)

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    End point title
    		 Insomnia due to hand-wrist problems 6 months (PR)
    End point description
    Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    81
    75
    Units: 2 categories
        No
    61
    59
        Yes
    20
    16
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 2.85

    Secondary: Referral to surgery at 6 months (PR)

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    End point title
    		 Referral to surgery at 6 months (PR)
    End point description
    Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. Per protocol analysis for comparison of the odds of insomnia between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    94
    85
    Units: 2 categories
        No
    78
    74
        Yes
    16
    11
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Splint v Steroid injection
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.52
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 3.01

    Secondary: Herbal remedies and vitamin use 6 months (PR)

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    End point title
    		 Herbal remedies and vitamin use 6 months (PR)
    End point description
    Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of herbal remedies and vitamin use between treatment groups at 6 months follow-up on participants with complete data. Per protocol analysis on complete date was planned. Comparison of outcome between treatment arms planned to adjust for sex, age, and duration of symptoms. Logistic regression was not performed due to small number of 'yes' counts.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    81
    73
    Units: 2 categories
        No
    78
    72
        Yes
    3
    1
    No statistical analyses for this end point

    Secondary: Over the counter pain medication 6 months (PR)

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    End point title
    		 Over the counter pain medication 6 months (PR)
    End point description
    Participants were asked if they bought over the counter paracetamol, ibuprofen or co-codamol to help with hand or wrist problems in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    81
    73
    Units: 2 categories
        No
    65
    58
        Yes
    16
    15
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.61
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 2.95

    Secondary: Prescribed pain medication 6 months (PR)

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    End point title
    		 Prescribed pain medication 6 months (PR)
    End point description
    Participants were asked if they were prescribed tablet medication (paracetamol, ibuprofen, naproxen, diclofenac, codeine, tramadol, co-codomal, tramacet, co-proxamol, dihydrocodeine, other) for hand or wrist problem in the last 6 months. Per protocol analysis for comparison of the odds of medication use between treatment groups at 6 months follow-up on participants with complete data.
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    83
    76
    Units: 2 categories
        No
    70
    70
        Yes
    13
    6
    Statistical analysis title
    		 Per protocol analysis at 6 months
    Statistical analysis description
    Per protocol analysis on complete date was performed. Comparison of outcome between treatment arms was adjusted for sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    159
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.14
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 6.58
    Notes
    [1] - Logistic regression was not performed due to small number of `yes' counts.

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (SG)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (SG)
    End point description
    Subgroup analysis was performed in patients who were allocated the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    24
    18
    Units: 1-5
        arithmetic mean (standard deviation)
    1.88 ( 0.76 )
    2.19 ( 0.75 )
    Statistical analysis title
    		 Subgroup analysis at 6 weeks
    Statistical analysis description
    Sub group analysis on complete data was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 -0.12

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (SG)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (SG)
    End point description
    Subgroup analysis was performed in patients who did not receive the intervention of their preference. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    18
    34
    Units: 1-5
        arithmetic mean (standard deviation)
    2.15 ( 0.91 )
    2.40 ( 0.84 )
    Statistical analysis title
    		 Subgroup analysis at 6 weeks
    Statistical analysis description
    Sub group analysis on complete data was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.26

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (SG)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (SG)
    End point description
    Subgroup analysis was performed in patients who did not state a preference of intervention. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    67
    61
    Units: 1-5
        arithmetic mean (standard deviation)
    2.03 ( 0.79 )
    2.26 ( 0.69 )
    Statistical analysis title
    		 Subgroup analysis at 6 weeks
    Statistical analysis description
    Sub group analysis on complete data was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    128
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 -0.05

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (SG)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (SG)
    End point description
    Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    24
    34
    Units: 1-5
        arithmetic mean (standard deviation)
    1.88 ( 0.76 )
    2.40 ( 0.84 )
    Statistical analysis title
    		 Subgroup analysis at 6 weeks
    Statistical analysis description
    Sub group analysis on complete data was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.97
         upper limit
    		 -0.23

    Secondary: BCTQ symptom severity and functional limitations 6 weeks (SG)

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    End point title
    		 BCTQ symptom severity and functional limitations 6 weeks (SG)
    End point description
    Subgroup analysis was performed in patients who preferred splint. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    18
    34
    Units: 1-5
        arithmetic mean (standard deviation)
    2.15 ( 0.91 )
    2.40 ( 0.84 )
    Statistical analysis title
    		 Subgroup analysis at 6 weeks
    Statistical analysis description
    Sub group analysis on complete data was performed. Comparison of outcome between treatment arms was adjusted for baseline score, sex, age, and duration of symptoms.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.25
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.16

    Secondary: NHS cost differences at 6 months

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    End point title
    		 NHS cost differences at 6 months
    End point description
    Cost of interventions at 6 months
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-infinity
        arithmetic mean (standard deviation)
    346.78 ( 467.97 )
    313.24 ( 480.84 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups performed on multiply imputed data
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    33.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -94.57
         upper limit
    		 145.59

    Secondary: NHS cost differences at 6 months (CC)

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    End point title
    		 NHS cost differences at 6 months (CC)
    End point description
    Complete case analysis on the cost of interventions at 6 months
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-infinity
        arithmetic mean (standard deviation)
    353.48 ( 512.85 )
    306.42 ( 524.51 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups on complete data.
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    47.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -104.84
         upper limit
    		 187.31

    Secondary: NHS cost differences at 12 months

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    End point title
    		 NHS cost differences at 12 months
    End point description
    Cost of interventions at 6 months
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-infinity
        arithmetic mean (standard deviation)
    508.69 ( 657.48 )
    395.54 ( 596.47 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    113.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.09
         upper limit
    		 279.21

    Secondary: NHS cost differences at 24 months

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    End point title
    		 NHS cost differences at 24 months
    End point description
    Cost of interventions at 24 months
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-infinity
        arithmetic mean (standard deviation)
    657.87 ( 808.57 )
    586.77 ( 783.45 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    71.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -120.84
         upper limit
    		 291.24

    Secondary: QALYS at 6 months (cross-walk tariff)

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    End point title
    		 QALYS at 6 months (cross-walk tariff)
    End point description
    QALYS (Quality adjusted life years)
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-1
        arithmetic mean (standard deviation)
    0.354 ( 0.093 )
    0.356 ( 0.087 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups adjusted for baseline utility
    Comparison groups
    Splint v Steroid injection
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.008
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.02

    Secondary: QALYS at 12 months (cross-walk tariff)

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    End point title
    		 QALYS at 12 months (cross-walk tariff)
    End point description
    QALYS (Quality adjusted life years)
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-1
        arithmetic mean (standard deviation)
    0.723 ( 0.163 )
    0.736 ( 0.156 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups adjusted for baseline utility
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.034
         upper limit
    		 0.027

    Secondary: QALYS at 24 months (cross-walk tariff)

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    End point title
    		 QALYS at 24 months (cross-walk tariff)
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Steroid injection Splint
    Number of subjects analysed
    116
    118
    Units: 0-1
        arithmetic mean (standard deviation)
    1.461 ( 0.311 )
    1.497 ( 0.301 )
    Statistical analysis title
    		 Health economics analysis
    Statistical analysis description
    Comparison of outcome between treatment groups adjusted for baseline utility
    Comparison groups
    Steroid injection v Splint
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.022
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.093
         upper limit
    		 0.045

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 months
    Adverse event reporting additional description
    Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Steroid injection
    Reporting group description
    		 One injection of 20mg methylprednisolone acetate to inflitrate the carpal tunnel

    Reporting group title
    Splint
    Reporting group description
    		 Participants received a beta wrist brace which immobilised the wrist in a neutral or slightly extended position intended to reduce pressure within the carpal tunnel, to wear at night for 6 weeks.

    Serious adverse events
    		 Steroid injection Splint
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 116 (2.59%)
    4 / 118 (3.39%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Injury, poisoning and procedural complications
    Fracture
    Additional description: Open comminuted fracture left middle finger, operative fixation with K-wires
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 116 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Other
    Additional description: Cryptogenic organising pneumonia
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Other
    Additional description: Patella resurfacing
         subjects affected / exposed
    1 / 116 (0.86%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
    Additional description: Total arthroplasty for osteoarthritis (one hip, one knee)
         subjects affected / exposed
    0 / 116 (0.00%)
    2 / 118 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Steroid injection Splint
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 116 (49.14%)
    7 / 118 (5.93%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    17 / 116 (14.66%)
    0 / 118 (0.00%)
         occurrences all number
    17
    0
    Skin and subcutaneous tissue disorders
    Other
    Additional description: Thinning, lightening or darkening of skin at injection site
         subjects affected / exposed
    4 / 116 (3.45%)
    0 / 118 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: For steroid injection, hand or wrist was more painful following injection. For splinting, participants unable to wear splint because of discomfort.
         subjects affected / exposed
    53 / 116 (45.69%)
    7 / 118 (5.93%)
         occurrences all number
    53
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2013
    Addition of questions concerning baseline characteristics, prognostic factors, employment, and effect of previous treatments to participant questionnaires. Changes to consent form, participant information leaflet.
    12 Sep 2013
    Change to protocol, participant information leaflet and consent form detailing hosting of the trial database on the University of Birmingham secure server.
    07 Nov 2014
    Change to protocol, participant information leaflet and consent form detailing moving trial database to Keele University secure server. Addition of question concerning laterality of symptoms to baseline questionnaire.
    19 Mar 2015
    Addition of two questions about undergoing surgery for hand/wrist problems to minimum data collection questionnaires.
    21 May 2015
    Clarification within protocol of the original intention with regard to processes relating to supply and administration of trial IMP under a patient group directive by specified authorised healthcare professionals.
    08 Aug 2016
    Change of Chief Investigator
    18 Jan 2018
    Clarification of reporting processes for deaths, non-fatal SAEs and pregnancies after 6-week follow-up.
    03 Sep 2018
    Update to Summary of Product Characteristics for methylprednisolone acetate.

    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.
    Trial participants and clinicians were not masked to treatment allocation. We recruited two short of the target 240 participants; however, statistical power was retained because of higher than anticipated follow-up rates.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27716159
    http://www.ncbi.nlm.nih.gov/pubmed/30343858
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