Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
hand, wrist, carpal, tunnel, syndrome, pragmatic, randomised, steroid, splint
Brief summary
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things. There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment. The study will 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 CTS in primary care.We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later. The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion. The steroid is a drug called DepoMedrone. This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.
Interventions
DRUGDepo-Medrone
Steroid Injection
DEVICEWrist Splint
Simple wrist splint
Sponsors
Arthritis Research UK
Keele University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 18 years * A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria * Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature * Symptom duration of episode of at least 6 weeks * Written informed consent provided by the patient, prior to any trial specific procedures
Exclusion criteria
* Steroid injection or night splints for CTS in the affected wrist within preceding 6 months * Any previous surgery on the affected wrist * Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion * Clinical suspicion of local or systemic sepsis or infection * Current or previous infection of the affected wrist * Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months * Unable to tolerate the study interventions * Unable to understand and complete self-report questionnaires written in English * Inter-current illness including, but not limited to: * poorly controlled thyroid disease * poorly controlled diabetes mellitus * vibration-induced neuropathy * inflammatory joint disease * suspected complex neurological conditions * any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation * Pregnant or lactating females * Receiving anticoagulants * Any history of hypersensitivity to Depo-Medrone or any of its excipients * Allergy to any of the splint materials * Known abuse of drugs or alcohol * Involved in on-going litigation cases for their condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks | 6 weeks | Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCTQ Functional Limitations Subscale 6 Weeks | 6 weeks | Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Weeks | 6 weeks | Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain). |
| Insomnia Due to Hand-wrist Problems 6 Weeks | 6 weeks | 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. |
| Referral for Surgery 6 Weeks | 6 weeks | Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed 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. |
| Surgery 6 Weeks | 6 weeks | Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed 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. |
| BCTQ Symptom Severity and Functional Limitations 6 Months | 6 months | Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Months | 6 months | Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Functional Limitations Subscale 6 Months | 6 months | Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Months | 6 months | Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain. |
| Insomnia Due to Hand-wrist Problems 6 Months | 6 months | 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. |
| Referral to Surgery 6 Months | 6 months | Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. |
| Surgery 6 Months | 6 months | Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months. |
| Herbal Remedies and Vitamin Use 6 Months | 6 months | Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months |
| Over the Counter Pain Medication 6 Months | 6 months | 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. |
| Prescribed Pain Medication 6 Months | 6 months | 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. |
| BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks | 6 weeks | Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months | 6 months | Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire. |
| BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months | 12 months | Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire. |
| Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months | 24 months | Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity Over 24 Months: 6 Weeks | 6 weeks | Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks. |
| Hand-wrist Pain Intensity Over 24 Months: 6 Months | 6 months | Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months. |
| Hand-wrist Pain Intensity Over 24 Months: 12 Months | 12 months | Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months. |
| Hand-wrist Pain Intensity Over 24 Months: 24 Months | 24 months | Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months. |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC)) | 6 weeks | Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Weeks (CC) | 6 weeks | Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Functional Limitations Subscale 6 Weeks (CC) | 6 weeks | Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Weeks (CC) | 6 weeks | Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. |
| Insomnia Due to Hand-wrist Problems 6 Weeks (CC) | 6 weeks | 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. |
| BCTQ Symptom Severity and Functional Limitations 6 Months (CC) | 6 months | Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Months (CC) | 6 months | Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Functional Limitations Subscale 6 Months (CC) | 6 months | Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Months (CC) | 6 months | Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. |
| Insomnia Due to Hand-wrist Problems 6 Months (CC) | 6 months | 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. |
| Referral to Surgery 6 Months (CC) | 6 months | 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. |
| Herbal Remedies and Vitamin Use 6 Months (CC) | 6 months | 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. |
| Over the Counter Pain Medication 6 Months (CC) | 6 months | 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. |
| Prescribed Pain Medication 6 Months (CC) | 6 months | 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. |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP)) | 6 weeks | Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Weeks (PP) | 6 weeks | Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Functional Limitations Subscale 6 Weeks (PP) | 6 weeks | Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Weeks (PP) | 6 weeks | 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. |
| Insomnia Due to Hand-wrist Problems 6 Weeks (PP) | 6 weeks | 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. |
| BCTQ Symptom Severity and Functional Limitations 6 Months (PP) | 6 months | Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Months (PP) | 6 months | Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Functional Limitations Subscale 6 Months (PP) | 6 months | Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| Hand-wrist Pain Intensity 6 Months (PP) | 6 months | Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data. |
| Insomnia Due to Hand-wrist Problems 6 Months (PP) | 6 months | 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. |
| Referral to Surgery at 6 Months (PP) | 6 months | 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 surgery between treatment groups at 6 months follow-up on participants with complete data. |
| Herbal Remedies and Vitamin Use 6 Months (PP) | 6 months | 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. |
| Over the Counter Pain Medication 6 Months (PP) | 6 months | 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 |
| Prescribed Pain Medication 6 Months (PP) | 6 months | 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. |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference) | 6 weeks | 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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference) | 6 weeks | 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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention) | 6 weeks | 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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection) | 6 weeks | Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire |
| BCTQ Symptom Severity Subscale 6 Weeks | 6 weeks | Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire |
| NHS Cost Differences at 6 Months | 6 months | Cost of interventions at 6 months |
| NHS Cost Differences at 6 Months (CC) | 6 months | Complete case analysis on the cost of interventions at 6 months |
| NHS Cost Differences at 12 Months | 12 months | Cost of interventions at 12 months |
| NHS Cost Differences at 24 Months | 24 months | Cost of interventions at 24 months |
| QALYS at 6 Months (Cross-walk Tariff) | 6 months | The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values. |
| QALYS at 12 Months (Cross-walk Tariff) | 12 months | The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values. |
| QALYS at 24 Months (Cross-walk Tariff) | 24 months | The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values. |
| BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint) | 6 weeks | 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 |
Countries
United Kingdom
Participant flow
Recruitment details
Patients were recruited from 25 General Practices and community musculoskeletal clinics between 17/04/2014 and 31/12/2016.
Pre-assignment details
Patients with a positive carpal tunnel syndrome (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. 750 patients were assessed for eligibility. 405 were eligible and 234 subsequently consented to randomisation.
Participants by arm
| Arm | Count |
|---|---|
| Steroid Injection Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
Depo-Medrone: Steroid Injection | 116 |
| Wrist Splint Wrist splint to be worn at night
Wrist Splint: Simple wrist splint | 118 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 31 | 28 |
| Overall Study | Withdrawal by Subject | 7 | 9 |
Baseline characteristics
| Characteristic | Steroid Injection | Wrist Splint | Total |
|---|---|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 17 | 52.2 years STANDARD_DEVIATION 14.9 | 52.4 years STANDARD_DEVIATION 15.9 |
| Any other conditions affecting neck, shoulders or elbows Missing | 3 Participants | 2 Participants | 5 Participants |
| Any other conditions affecting neck, shoulders or elbows No | 68 Participants | 88 Participants | 156 Participants |
| Any other conditions affecting neck, shoulders or elbows Yes | 45 Participants | 28 Participants | 73 Participants |
| Been bother by feeling down, depressed or hopeless Missing | 3 Participants | 1 Participants | 4 Participants |
| Been bother by feeling down, depressed or hopeless No | 66 Participants | 78 Participants | 144 Participants |
| Been bother by feeling down, depressed or hopeless Yes | 47 Participants | 39 Participants | 86 Participants |
| Been bothered by little interest or pleasure in doing things Missing | 3 Participants | 2 Participants | 5 Participants |
| Been bothered by little interest or pleasure in doing things No | 74 Participants | 83 Participants | 157 Participants |
| Been bothered by little interest or pleasure in doing things Yes | 39 Participants | 33 Participants | 72 Participants |
| Body mass index | 30.2 kg/m2 STANDARD_DEVIATION 7.6 | 30.5 kg/m2 STANDARD_DEVIATION 7.5 | 30.4 kg/m2 STANDARD_DEVIATION 7.6 |
| Boston carpal tunnel functional limitations subscale | 2.32 units on a scale STANDARD_DEVIATION 0.92 | 2.28 units on a scale STANDARD_DEVIATION 0.84 | 2.30 units on a scale STANDARD_DEVIATION 0.88 |
| Boston carpal tunnel symptom severity and functional limitations | 2.69 units on a scale STANDARD_DEVIATION 0.7 | 2.65 units on a scale STANDARD_DEVIATION 0.62 | 2.67 units on a scale STANDARD_DEVIATION 0.66 |
| Boston carpal tunnel symptom severity subscale | 2.96 units on a scale STANDARD_DEVIATION 0.66 | 2.91 units on a scale STANDARD_DEVIATION 0.61 | 2.94 units on a scale STANDARD_DEVIATION 0.63 |
| Curently taking pain relief Missing | 3 Participants | 1 Participants | 4 Participants |
| Curently taking pain relief No | 77 Participants | 83 Participants | 160 Participants |
| Curently taking pain relief Yes | 36 Participants | 34 Participants | 70 Participants |
| Describes current situation in respect of your job Doing lighter duties | 1 Participants | 6 Participants | 7 Participants |
| Describes current situation in respect of your job Doing my usual job | 50 Participants | 62 Participants | 112 Participants |
| Describes current situation in respect of your job Missing | 4 Participants | 2 Participants | 6 Participants |
| Describes current situation in respect of your job N/A | 55 Participants | 42 Participants | 97 Participants |
| Describes current situation in respect of your job On paid annual leave/holiday | 2 Participants | 1 Participants | 3 Participants |
| Describes current situation in respect of your job On paid sick leave | 3 Participants | 3 Participants | 6 Participants |
| Describes current situation in respect of your job On unpaid sick leave | 0 Participants | 0 Participants | 0 Participants |
| Describes current situation in respect of your job Working fewer hours | 1 Participants | 2 Participants | 3 Participants |
| Diagnosed with diabetes Missing | 4 Participants | 1 Participants | 5 Participants |
| Diagnosed with diabetes No | 99 Participants | 109 Participants | 208 Participants |
| Diagnosed with diabetes Yes | 13 Participants | 8 Participants | 21 Participants |
| Diagnosed with hypothyroidism Missing | 3 Participants | 2 Participants | 5 Participants |
| Diagnosed with hypothyroidism No | 108 Participants | 107 Participants | 215 Participants |
| Diagnosed with hypothyroidism Yes | 5 Participants | 9 Participants | 14 Participants |
| Dominant hand Left | 12 Participants | 16 Participants | 28 Participants |
| Dominant hand Missing | 5 Participants | 3 Participants | 8 Participants |
| Dominant hand Right | 99 Participants | 99 Participants | 198 Participants |
| Duration of hand or wrist problems >1 year | 34 Participants | 39 Participants | 73 Participants |
| Duration of hand or wrist problems 3-6 months | 37 Participants | 33 Participants | 70 Participants |
| Duration of hand or wrist problems <3 months | 19 Participants | 17 Participants | 36 Participants |
| Duration of hand or wrist problems 6 months-1 year | 22 Participants | 27 Participants | 49 Participants |
| Duration of hand or wrist problems Missing | 4 Participants | 2 Participants | 6 Participants |
| First time diagnosed with carpal tunnel syndrome Missing | 3 Participants | 1 Participants | 4 Participants |
| First time diagnosed with carpal tunnel syndrome No | 16 Participants | 15 Participants | 31 Participants |
| First time diagnosed with carpal tunnel syndrome Yes | 97 Participants | 102 Participants | 199 Participants |
| Had pain anywhere else Missing | 3 Participants | 1 Participants | 4 Participants |
| Had pain anywhere else No | 39 Participants | 45 Participants | 84 Participants |
| Had pain anywhere else Yes | 74 Participants | 72 Participants | 146 Participants |
| Hand or wrist previously affected by carpal tunnel syndrome Both | 8 Participants | 9 Participants | 17 Participants |
| Hand or wrist previously affected by carpal tunnel syndrome Left | 1 Participants | 2 Participants | 3 Participants |
| Hand or wrist previously affected by carpal tunnel syndrome Missing | 4 Participants | 2 Participants | 6 Participants |
| Hand or wrist previously affected by carpal tunnel syndrome N/A | 97 Participants | 102 Participants | 199 Participants |
| Hand or wrist previously affected by carpal tunnel syndrome Right | 6 Participants | 3 Participants | 9 Participants |
| Hand-wrist pain intensity | 6.33 units on a scale STANDARD_DEVIATION 2.05 | 6.12 units on a scale STANDARD_DEVIATION 2.21 | 6.23 units on a scale STANDARD_DEVIATION 2.13 |
| Has insomnia due to hand or wrist problem No | 46 Participants | 58 Participants | 104 Participants |
| Has insomnia due to hand or wrist problem Yes | 70 Participants | 60 Participants | 130 Participants |
| How did your hand or wrist problems start Gradually | 79 Participants | 99 Participants | 178 Participants |
| How did your hand or wrist problems start Missing | 4 Participants | 2 Participants | 6 Participants |
| How did your hand or wrist problems start Suddenly | 33 Participants | 17 Participants | 50 Participants |
| If both hands problematic, which hand was worse Left | 13 Participants | 19 Participants | 32 Participants |
| If both hands problematic, which hand was worse Missing | 16 Participants | 15 Participants | 31 Participants |
| If both hands problematic, which hand was worse N/A | 55 Participants | 57 Participants | 112 Participants |
| If both hands problematic, which hand was worse No difference | 7 Participants | 3 Participants | 10 Participants |
| If both hands problematic, which hand was worse Right | 25 Participants | 24 Participants | 49 Participants |
| I feel my welfare is important to my employer Agree | 4 Participants | 3 Participants | 7 Participants |
| I feel my welfare is important to my employer Disagree | 0 Participants | 0 Participants | 0 Participants |
| I feel my welfare is important to my employer Missing | 4 Participants | 2 Participants | 6 Participants |
| I feel my welfare is important to my employer N/A | 104 Participants | 111 Participants | 215 Participants |
| I feel my welfare is important to my employer Strongly agree | 4 Participants | 2 Participants | 6 Participants |
| I feel my welfare is important to my employer Strongly disagree | 0 Participants | 0 Participants | 0 Participants |
| If not doing usual job/annual leave, is this due to your hand or wrist problems Missing | 6 Participants | 3 Participants | 9 Participants |
| If not doing usual job/annual leave, is this due to your hand or wrist problems N/A | 105 Participants | 105 Participants | 210 Participants |
| If not doing usual job/annual leave, is this due to your hand or wrist problems No | 3 Participants | 6 Participants | 9 Participants |
| If not doing usual job/annual leave, is this due to your hand or wrist problems Yes | 2 Participants | 4 Participants | 6 Participants |
| If not in a current paid job, describe current position Looking after children/home | 12 participants | 9 participants | 21 participants |
| If not in a current paid job, describe current position N/A | 58 participants | 74 participants | 132 participants |
| If not in a current paid job, describe current position Retired | 38 participants | 29 participants | 67 participants |
| If not in a current paid job, describe current position Student | 3 participants | 1 participants | 4 participants |
| If not in a current paid job, describe current position Unemployed | 3 participants | 7 participants | 10 participants |
| If not in a current paid job, describe current position Voluntary worker | 2 participants | 0 participants | 2 participants |
| If you had received wrist injection, would you expect your symptoms to improve Missing | 8 Participants | 5 Participants | 13 Participants |
| If you had received wrist injection, would you expect your symptoms to improve No | 0 Participants | 2 Participants | 2 Participants |
| If you had received wrist injection, would you expect your symptoms to improve Not sure | 39 Participants | 41 Participants | 80 Participants |
| If you had received wrist injection, would you expect your symptoms to improve Yes | 69 Participants | 70 Participants | 139 Participants |
| If you received night splint, would you expect your symptoms to improve Missing | 9 Participants | 5 Participants | 14 Participants |
| If you received night splint, would you expect your symptoms to improve No | 3 Participants | 4 Participants | 7 Participants |
| If you received night splint, would you expect your symptoms to improve Not sure | 58 Participants | 69 Participants | 127 Participants |
| If you received night splint, would you expect your symptoms to improve Yes | 46 Participants | 40 Participants | 86 Participants |
| In a current paid job Missing | 3 Participants | 2 Participants | 5 Participants |
| In a current paid job No | 55 Participants | 42 Participants | 97 Participants |
| In a current paid job Yes | 58 Participants | 74 Participants | 132 Participants |
| Last time you were free of pain 1-3 years ago | 38 Participants | 23 Participants | 61 Participants |
| Last time you were free of pain 3-6 months ago | 13 Participants | 19 Participants | 32 Participants |
| Last time you were free of pain <3 months ago | 22 Participants | 20 Participants | 42 Participants |
| Last time you were free of pain >3 years ago | 31 Participants | 32 Participants | 63 Participants |
| Last time you were free of pain 6 months-1 year ago | 9 Participants | 23 Participants | 32 Participants |
| Last time you were free of pain Missing | 3 Participants | 1 Participants | 4 Participants |
| My hand or wrist problem affects me emotionally Agree | 40 Participants | 45 Participants | 85 Participants |
| My hand or wrist problem affects me emotionally Disagree | 17 Participants | 19 Participants | 36 Participants |
| My hand or wrist problem affects me emotionally Missing | 3 Participants | 2 Participants | 5 Participants |
| My hand or wrist problem affects me emotionally Neither agree nor disagree | 17 Participants | 21 Participants | 38 Participants |
| My hand or wrist problem affects me emotionally Strongly agree | 29 Participants | 13 Participants | 42 Participants |
| My hand or wrist problem affects me emotionally Strongly disagree | 10 Participants | 18 Participants | 28 Participants |
| My hand or wrist problem has major consequences on my life Agree | 41 Participants | 37 Participants | 78 Participants |
| My hand or wrist problem has major consequences on my life Disagree | 19 Participants | 22 Participants | 41 Participants |
| My hand or wrist problem has major consequences on my life Missing | 3 Participants | 2 Participants | 5 Participants |
| My hand or wrist problem has major consequences on my life Neither agree nor disagree | 26 Participants | 30 Participants | 56 Participants |
| My hand or wrist problem has major consequences on my life Strongly agree | 23 Participants | 17 Participants | 40 Participants |
| My hand or wrist problem has major consequences on my life Strongly disagree | 4 Participants | 10 Participants | 14 Participants |
| My hand or wrist problem will last for a long time Agree | 44 Participants | 42 Participants | 86 Participants |
| My hand or wrist problem will last for a long time Disagree | 7 Participants | 8 Participants | 15 Participants |
| My hand or wrist problem will last for a long time Missing | 3 Participants | 2 Participants | 5 Participants |
| My hand or wrist problem will last for a long time Neither agree nor disagree | 45 Participants | 51 Participants | 96 Participants |
| My hand or wrist problem will last for a long time Strongly agree | 14 Participants | 12 Participants | 26 Participants |
| My hand or wrist problem will last for a long time Strongly disagree | 3 Participants | 3 Participants | 6 Participants |
| Number of days per week taking pain relief 1 | 0 Participants | 0 Participants | 0 Participants |
| Number of days per week taking pain relief 2 | 1 Participants | 4 Participants | 5 Participants |
| Number of days per week taking pain relief 3 | 3 Participants | 0 Participants | 3 Participants |
| Number of days per week taking pain relief 4 | 1 Participants | 0 Participants | 1 Participants |
| Number of days per week taking pain relief 5 | 2 Participants | 2 Participants | 4 Participants |
| Number of days per week taking pain relief 6 | 0 Participants | 0 Participants | 0 Participants |
| Number of days per week taking pain relief 7 | 14 Participants | 7 Participants | 21 Participants |
| Number of days per week taking pain relief Missing | 18 Participants | 22 Participants | 40 Participants |
| Number of days per week taking pain relief N/A | 77 Participants | 83 Participants | 160 Participants |
| Number of times a day taking pain relief 1 | 7 Participants | 8 Participants | 15 Participants |
| Number of times a day taking pain relief 2 | 13 Participants | 5 Participants | 18 Participants |
| Number of times a day taking pain relief 3 | 5 Participants | 5 Participants | 10 Participants |
| Number of times a day taking pain relief 4 | 3 Participants | 5 Participants | 8 Participants |
| Number of times a day taking pain relief 5 | 0 Participants | 1 Participants | 1 Participants |
| Number of times a day taking pain relief Missing | 11 Participants | 11 Participants | 22 Participants |
| Number of times a day taking pain relief N/A | 77 Participants | 83 Participants | 160 Participants |
| Number of times previously had carpal tunnel syndrome 1 | 11 Participants | 8 Participants | 19 Participants |
| Number of times previously had carpal tunnel syndrome 2 | 1 Participants | 1 Participants | 2 Participants |
| Number of times previously had carpal tunnel syndrome 3 | 0 Participants | 0 Participants | 0 Participants |
| Number of times previously had carpal tunnel syndrome Missing | 4 Participants | 3 Participants | 7 Participants |
| Number of times previously had carpal tunnel syndrome More than 3 | 3 Participants | 4 Participants | 7 Participants |
| Number of times previously had carpal tunnel syndrome N/A | 97 Participants | 102 Participants | 199 Participants |
| Number of weeks in a month taking pain relief 1 | 1 Participants | 0 Participants | 1 Participants |
| Number of weeks in a month taking pain relief 2 | 2 Participants | 1 Participants | 3 Participants |
| Number of weeks in a month taking pain relief 3 | 1 Participants | 0 Participants | 1 Participants |
| Number of weeks in a month taking pain relief 4 | 17 Participants | 9 Participants | 26 Participants |
| Number of weeks in a month taking pain relief Missing | 18 Participants | 25 Participants | 43 Participants |
| Number of weeks in a month taking pain relief N/A | 77 Participants | 83 Participants | 160 Participants |
| On average, how often do you drink alcohol Daily or most days | 11 Participants | 11 Participants | 22 Participants |
| On average, how often do you drink alcohol Missing | 3 Participants | 1 Participants | 4 Participants |
| On average, how often do you drink alcohol Never | 23 Participants | 21 Participants | 44 Participants |
| On average, how often do you drink alcohol Once or twice a month | 25 Participants | 22 Participants | 47 Participants |
| On average, how often do you drink alcohol Once or twice a week | 38 Participants | 45 Participants | 83 Participants |
| On average, how often do you drink alcohol Once or twice a year | 16 Participants | 18 Participants | 34 Participants |
| Particular position causes hand or wrist problems Missing | 4 Participants | 2 Participants | 6 Participants |
| Particular position causes hand or wrist problems No | 62 Participants | 54 Participants | 116 Participants |
| Particular position causes hand or wrist problems Yes | 50 Participants | 62 Participants | 112 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 116 participants | 118 participants | 234 participants |
| Sex: Female, Male Female | 73 Participants | 81 Participants | 154 Participants |
| Sex: Female, Male Male | 43 Participants | 37 Participants | 80 Participants |
| Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome Missing | 3 Participants | 1 Participants | 4 Participants |
| Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome N/A | 97 Participants | 102 Participants | 199 Participants |
| Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome No | 7 Participants | 6 Participants | 13 Participants |
| Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome Yes | 9 Participants | 9 Participants | 18 Participants |
| Taken time off work during the last 6 months for your hand or wrist problems Missing | 4 Participants | 2 Participants | 6 Participants |
| Taken time off work during the last 6 months for your hand or wrist problems N/A | 55 Participants | 42 Participants | 97 Participants |
| Taken time off work during the last 6 months for your hand or wrist problems No | 49 Participants | 69 Participants | 118 Participants |
| Taken time off work during the last 6 months for your hand or wrist problems Yes | 8 Participants | 5 Participants | 13 Participants |
| There is a lot that I can do to control my hand or wrist problems Agree | 30 Participants | 32 Participants | 62 Participants |
| There is a lot that I can do to control my hand or wrist problems Disagree | 21 Participants | 31 Participants | 52 Participants |
| There is a lot that I can do to control my hand or wrist problems Missing | 3 Participants | 2 Participants | 5 Participants |
| There is a lot that I can do to control my hand or wrist problems Neither agree nor disagree | 48 Participants | 42 Participants | 90 Participants |
| There is a lot that I can do to control my hand or wrist problems Strongly agree | 2 Participants | 2 Participants | 4 Participants |
| There is a lot that I can do to control my hand or wrist problems Strongly disagree | 12 Participants | 9 Participants | 21 Participants |
| To what extent have hand or wrist problems affected your performance at work over the past month | 3.8 units on a scale STANDARD_DEVIATION 3 | 4.2 units on a scale STANDARD_DEVIATION 2.9 | 4.0 units on a scale STANDARD_DEVIATION 3 |
| Treatment can control my hand or wrist problem Agree | 74 Participants | 71 Participants | 145 Participants |
| Treatment can control my hand or wrist problem Disagree | 3 Participants | 0 Participants | 3 Participants |
| Treatment can control my hand or wrist problem Missing | 3 Participants | 3 Participants | 6 Participants |
| Treatment can control my hand or wrist problem Neither agree nor disagree | 20 Participants | 35 Participants | 55 Participants |
| Treatment can control my hand or wrist problem Strongly agree | 16 Participants | 9 Participants | 25 Participants |
| Treatment can control my hand or wrist problem Strongly disagree | 0 Participants | 0 Participants | 0 Participants |
| Treatment for previous carpal tunnel syndrome Carpal tunnel decompression | 3 participants | 2 participants | 5 participants |
| Treatment for previous carpal tunnel syndrome Changes in workplace | 0 participants | 0 participants | 0 participants |
| Treatment for previous carpal tunnel syndrome Exercises | 0 participants | 0 participants | 0 participants |
| Treatment for previous carpal tunnel syndrome N/A | 97 participants | 102 participants | 199 participants |
| Treatment for previous carpal tunnel syndrome None | 5 participants | 8 participants | 13 participants |
| Treatment for previous carpal tunnel syndrome Other | 1 participants | 0 participants | 1 participants |
| Treatment for previous carpal tunnel syndrome Steroid injection | 3 participants | 4 participants | 7 participants |
| Treatment for previous carpal tunnel syndrome Ultrasound | 1 participants | 1 participants | 2 participants |
| Treatment for previous carpal tunnel syndrome Vitamin supplements | 0 participants | 1 participants | 1 participants |
| Treatment for previous carpal tunnel syndrome Wrist splint | 7 participants | 4 participants | 11 participants |
| Typical weekly working hours Full time | 39 Participants | 47 Participants | 86 Participants |
| Typical weekly working hours Missing | 4 Participants | 2 Participants | 6 Participants |
| Typical weekly working hours N/A | 55 Participants | 42 Participants | 97 Participants |
| Typical weekly working hours Part time | 18 Participants | 27 Participants | 45 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome Missing | 3 Participants | 1 Participants | 4 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome N/A | 104 Participants | 108 Participants | 212 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome Of great help | 7 Participants | 7 Participants | 14 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome Of little help | 0 Participants | 0 Participants | 0 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome Of no help | 1 Participants | 1 Participants | 2 Participants |
| Usefulness of injection into other joint if previously had carpal tunnel syndrome Of some help | 1 Participants | 1 Participants | 2 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Agree | 49 Participants | 57 Participants | 106 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Disagree | 11 Participants | 14 Participants | 25 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Missing | 3 Participants | 2 Participants | 5 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Neither agree nor disagree | 40 Participants | 32 Participants | 72 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Strongly agree | 9 Participants | 9 Participants | 18 Participants |
| What I can do determines whether my hand or wrist problems gets better or worse Strongly disagree | 4 Participants | 4 Participants | 8 Participants |
| What is your current smoking status Current smoker | 19 Participants | 13 Participants | 32 Participants |
| What is your current smoking status Missing | 3 Participants | 2 Participants | 5 Participants |
| What is your current smoking status Never smoked | 55 Participants | 55 Participants | 110 Participants |
| What is your current smoking status Previously smoked | 39 Participants | 48 Participants | 87 Participants |
| Which problematic hand or wrist Both | 57 Participants | 59 Participants | 116 Participants |
| Which problematic hand or wrist Left | 19 Participants | 20 Participants | 39 Participants |
| Which problematic hand or wrist Missing | 4 Participants | 2 Participants | 6 Participants |
| Which problematic hand or wrist Right | 36 Participants | 37 Participants | 73 Participants |
| Which treatment would you prefer Missing | 9 Participants | 6 Participants | 15 Participants |
| Which treatment would you prefer No preference | 65 Participants | 60 Participants | 125 Participants |
| Which treatment would you prefer Somewhat prefer night splints | 12 Participants | 8 Participants | 20 Participants |
| Which treatment would you prefer Somewhat prefer wrist injection | 11 Participants | 21 Participants | 32 Participants |
| Which treatment would you prefer Strongly prefer night splints | 6 Participants | 10 Participants | 16 Participants |
| Which treatment would you prefer Strongly prefer wrist injection | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 116 | 0 / 118 |
| other Total, other adverse events | 57 / 116 | 7 / 118 |
| serious Total, serious adverse events | 3 / 116 | 4 / 118 |
Outcome results
Primary
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks | 2.02 score on a scale | Standard Deviation 0.81 |
| Wrist Splint | Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks | 2.29 score on a scale | Standard Deviation 0.75 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: <0.00195% CI: [-0.48, -0.16]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Months
Comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Months | 1.91 score on a scale | Standard Deviation 0.84 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Months | 1.89 score on a scale | Standard Deviation 0.84 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.9695% CI: [-0.175, 0.166]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Months (CC)
Sensitivity analysis for comparison of BCTQ function limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Months (CC) | 1.85 score on a scale | Standard Deviation 0.84 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Months (CC) | 1.88 score on a scale | Standard Deviation 0.82 |
p-value: 0.9395% CI: [-0.17, 0.18]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Months (PP)
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Months (PP) | 1.89 score on a scale | Standard Deviation 0.87 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Months (PP) | 1.84 score on a scale | Standard Deviation 0.77 |
p-value: 0.995% CI: [-0.18, 0.2]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Weeks
Comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (1-5 scale, higher score indicates more severe functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Weeks | 1.88 score on a scale | Standard Deviation 0.88 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Weeks | 2.09 score on a scale | Standard Deviation 0.86 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.00395% CI: [-0.43, -0.09]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Weeks (CC)
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Weeks (CC) | 1.86 score on a scale | Standard Deviation 0.91 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Weeks (CC) | 2.10 score on a scale | Standard Deviation 0.86 |
p-value: 0.00595% CI: [-0.44, -0.08]Regression, Linear
Secondary
BCTQ Functional Limitations Subscale 6 Weeks (PP)
Per protocol analysis for comparison of BCTQ functional limitations between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Functional Limitations Subscale 6 Weeks (PP) | 1.88 score on a scale | Standard Deviation 0.94 |
| Wrist Splint | BCTQ Functional Limitations Subscale 6 Weeks (PP) | 2.06 score on a scale | Standard Deviation 0.8 |
p-value: 0.00395% CI: [-0.46, -0.09]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Months
Comparison of overall BCTQ between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Months | 2.15 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Months | 2.06 score on a scale | Standard Deviation 0.73 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.595% CI: [-0.11, 0.23]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Months (CC)
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Months (CC) | 2.08 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Months (CC) | 2.04 score on a scale | Standard Deviation 0.72 |
p-value: 0.5895% CI: [-0.13, 0.24]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Months (PP)
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Months (PP) | 2.09 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Months (PP) | 2.02 score on a scale | Standard Deviation 0.69 |
p-value: 0.6395% CI: [-0.15, 0.25]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))
Sensitivity analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC)) | 1.95 score on a scale | Standard Deviation 0.82 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC)) | 2.29 score on a scale | Standard Deviation 0.77 |
p-value: <0.00195% CI: [-0.54, -0.19]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))
Per protocol analysis for comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP)) | 1.96 score on a scale | Standard Deviation 0.84 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP)) | 2.28 score on a scale | Standard Deviation 0.72 |
p-value: <0.00195% CI: [-0.55, -0.18]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)
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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference) | 2.15 score on a scale | Standard Deviation 0.91 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference) | 2.40 score on a scale | Standard Deviation 0.84 |
p-value: 0.5395% CI: [-0.5, 0.26]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)
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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention) | 2.03 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention) | 2.26 score on a scale | Standard Deviation 0.69 |
p-value: 0.01595% CI: [-0.44, -0.05]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)
Subgroup analysis was performed in patients who preferred injection. Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection) | 1.88 score on a scale | Standard Deviation 0.76 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection) | 2.40 score on a scale | Standard Deviation 0.84 |
p-value: 0.00295% CI: [-0.97, -0.23]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)
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
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint) | 2.15 score on a scale | Standard Deviation 0.91 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint) | 2.40 score on a scale | Standard Deviation 0.84 |
p-value: 0.2595% CI: [-0.6, 0.16]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)
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 (scale 1-5, higher score indicates more severe symptoms and functional impairment) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference) | 1.88 score on a scale | Standard Deviation 0.76 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference) | 2.19 score on a scale | Standard Deviation 0.75 |
p-value: 0.01495% CI: [-0.93, -0.12]Regression, Linear
Secondary
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment). Results are presented at 12 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months | 1.98 score on a scale | Standard Deviation 0.88 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months | 2.05 score on a scale | Standard Deviation 0.8 |
p-value: 0.4195% CI: [-0.3, 0.12]Mixed Models Analysis
Secondary
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up. Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 months. BCTQ: Boston Carpal Tunnel Questionnaire.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months | 2.08 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months | 2.04 score on a scale | Standard Deviation 0.72 |
p-value: 0.7495% CI: [-0.17, 0.24]Mixed Models Analysis
Secondary
BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 6 weeks. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks | 1.95 score on a scale | Standard Deviation 0.82 |
| Wrist Splint | BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks | 2.30 score on a scale | Standard Deviation 0.77 |
p-value: 0.00195% CI: [-0.53, -0.14]Mixed Models Analysis
Secondary
BCTQ Symptom Severity Subscale 6 Months
Comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (1-5 scale, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Months | 2.33 score on a scale | Standard Deviation 0.86 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Months | 2.18 score on a scale | Standard Deviation 0.75 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.2195% CI: [-0.07, 0.33]Regression, Linear
Secondary
BCTQ Symptom Severity Subscale 6 Months (CC)
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Months (CC) | 2.29 score on a scale | Standard Deviation 0.87 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Months (CC) | 2.16 score on a scale | Standard Deviation 0.74 |
p-value: 0.2595% CI: [-0.09, 0.35]Regression, Linear
Secondary
BCTQ Symptom Severity Subscale 6 Months (PP)
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 months follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Months (PP) | 2.28 score on a scale | Standard Deviation 0.86 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Months (PP) | 2.15 score on a scale | Standard Deviation 0.73 |
p-value: 0.2895% CI: [-0.1, 0.35]Regression, Linear
Secondary
BCTQ Symptom Severity Subscale 6 Weeks
Comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms). BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Weeks | 2.12 score on a scale | Standard Deviation 0.84 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Weeks | 2.43 score on a scale | Standard Deviation 0.76 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: <0.00195% CI: [-0.53, -0.17]Regression, Linear
Secondary
BCTQ Symptom Severity Subscale 6 Weeks (CC)
Sensitivity analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Weeks (CC) | 2.07 score on a scale | Standard Deviation 0.83 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Weeks (CC) | 2.44 score on a scale | Standard Deviation 0.78 |
p-value: <0.00195% CI: [-0.59, -0.21]Regression, Linear
Secondary
BCTQ Symptom Severity Subscale 6 Weeks (PP)
Per protocol analysis for comparison of BCTQ symptom severity between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms) on participants with complete data. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | BCTQ Symptom Severity Subscale 6 Weeks (PP) | 2.07 score on a scale | Standard Deviation 0.83 |
| Wrist Splint | BCTQ Symptom Severity Subscale 6 Weeks (PP) | 2.44 score on a scale | Standard Deviation 0.74 |
p-value: <0.00195% CI: [-0.59, -0.19]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Months
Comparison of pain scores between treatment groups at 6 months follow-up. 0-10 scale, higher score indicates more pain.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Months | 4.32 units on a scale | Standard Deviation 3.26 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Months | 3.46 units on a scale | Standard Deviation 3.01 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.05595% CI: [-0.02, 1.59]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Months (CC)
Sensitivity analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Months (CC) | 4.11 score on a scale | Standard Deviation 3.01 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Months (CC) | 3.29 score on a scale | Standard Deviation 2.74 |
p-value: 0.05295% CI: [-0.01, 1.61]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Months (PP)
Per protocol analysis for comparison of pain scores between treatment groups at 6 months follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Months (PP) | 4.11 score on a scale | Standard Deviation 2.99 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Months (PP) | 3.38 score on a scale | Standard Deviation 2.79 |
p-value: 0.0995% CI: [-0.11, 1.59]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Weeks
Comparison of pain scores between treatment groups at 6 weeks follow-up (0-10 scale, higher score indicates more pain).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Weeks | 3.42 units on a scale | Standard Deviation 2.77 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Weeks | 4.28 units on a scale | Standard Deviation 2.73 |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.00595% CI: [-1.64, -0.3]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Weeks (CC)
Sensitivity analysis for comparison of pain scores between treatment groups at 6 weeks follow-up (scale 0-10, higher score indicates more pain) on participants with complete data.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Weeks (CC) | 3.33 score on a scale | Standard Deviation 2.67 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Weeks (CC) | 4.28 score on a scale | Standard Deviation 2.62 |
p-value: 0.00295% CI: [-1.72, -0.38]Regression, Linear
Secondary
Hand-wrist Pain Intensity 6 Weeks (PP)
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity 6 Weeks (PP) | 3.33 score on a scale | Standard Deviation 2.67 |
| Wrist Splint | Hand-wrist Pain Intensity 6 Weeks (PP) | 4.44 score on a scale | Standard Deviation 2.5 |
p-value: 0.00195% CI: [-1.85, -0.48]Regression, Linear
Secondary
Hand-wrist Pain Intensity Over 24 Months: 12 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 12 months.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity Over 24 Months: 12 Months | 3.17 score on a scale | Standard Deviation 2.93 |
| Wrist Splint | Hand-wrist Pain Intensity Over 24 Months: 12 Months | 3.14 score on a scale | Standard Deviation 2.74 |
p-value: 0.9595% CI: [-0.79, 0.85]Mixed Models Analysis
Secondary
Hand-wrist Pain Intensity Over 24 Months: 24 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 24 months.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity Over 24 Months: 24 Months | 2.81 score on a scale | Standard Deviation 3.19 |
| Wrist Splint | Hand-wrist Pain Intensity Over 24 Months: 24 Months | 2.40 score on a scale | Standard Deviation 2.83 |
p-value: 0.3595% CI: [-0.45, 1.26]Mixed Models Analysis
Secondary
Hand-wrist Pain Intensity Over 24 Months: 6 Months
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity Over 24 Months: 6 Months | 4.11 score on a scale | Standard Deviation 3.01 |
| Wrist Splint | Hand-wrist Pain Intensity Over 24 Months: 6 Months | 3.29 score on a scale | Standard Deviation 2.74 |
p-value: 0.05895% CI: [-0.02, 1.54]Mixed Models Analysis
Secondary
Hand-wrist Pain Intensity Over 24 Months: 6 Weeks
Comparison of pain scores between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 0-10, higher score indicates more pain. Results are presented at 6 weeks.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Hand-wrist Pain Intensity Over 24 Months: 6 Weeks | 3.33 score on a scale | Standard Deviation 2.67 |
| Wrist Splint | Hand-wrist Pain Intensity Over 24 Months: 6 Weeks | 4.28 score on a scale | Standard Deviation 2.62 |
p-value: 0.00995% CI: [-1.72, -0.24]Mixed Models Analysis
Secondary
Herbal Remedies and Vitamin Use 6 Months
Participants were asked if they had bought herbal remedies or vitamins to help with hand or wrist problems in the last 6 months
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months | No | 109 Participants |
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months | Yes | 7 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months | No | 111 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months | Yes | 7 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.6695% CI: [0.28, 7.34]Regression, Logistic
Secondary
Herbal Remedies and Vitamin Use 6 Months (CC)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months (CC) | No | 78 Participants |
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months (CC) | Yes | 2 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months (CC) | No | 81 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months (CC) | Yes | 2 Participants |
Secondary
Herbal Remedies and Vitamin Use 6 Months (PP)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months (PP) | No | 78 Participants |
| Steroid Injection | Herbal Remedies and Vitamin Use 6 Months (PP) | Yes | 3 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months (PP) | No | 72 Participants |
| Wrist Splint | Herbal Remedies and Vitamin Use 6 Months (PP) | Yes | 1 Participants |
Secondary
Insomnia Due to Hand-wrist Problems 6 Months
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months | No | 79 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months | Yes | 37 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months | No | 86 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months | Yes | 32 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.7695% CI: [0.55, 2.2]Regression, Logistic
Secondary
Insomnia Due to Hand-wrist Problems 6 Months (CC)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months (CC) | No | 60 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months (CC) | Yes | 20 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months (CC) | No | 68 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months (CC) | Yes | 18 Participants |
p-value: 0.5395% CI: [0.58, 2.88]Regression, Logistic
Secondary
Insomnia Due to Hand-wrist Problems 6 Months (PP)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months (PP) | No | 61 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Months (PP) | Yes | 20 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months (PP) | No | 59 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Months (PP) | Yes | 16 Participants |
p-value: 0.5895% CI: [0.56, 2.85]Regression, Logistic
Secondary
Insomnia Due to Hand-wrist Problems 6 Weeks
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.
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks | No | 83 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks | Yes | 33 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks | No | 73 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks | Yes | 45 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.01895% CI: [0.22, 0.87]Regression, Logistic
Secondary
Insomnia Due to Hand-wrist Problems 6 Weeks (CC)
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.
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks (CC) | No | 75 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks (CC) | Yes | 22 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks (CC) | No | 62 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks (CC) | Yes | 34 Participants |
p-value: 0.00695% CI: [0.17, 0.74]Regression, Logistic
Secondary
Insomnia Due to Hand-wrist Problems 6 Weeks (PP)
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.
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks (PP) | No | 74 Participants |
| Steroid Injection | Insomnia Due to Hand-wrist Problems 6 Weeks (PP) | Yes | 21 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks (PP) | No | 57 Participants |
| Wrist Splint | Insomnia Due to Hand-wrist Problems 6 Weeks (PP) | Yes | 30 Participants |
p-value: 0.00795% CI: [0.16, 0.74]Regression, Logistic
Secondary
NHS Cost Differences at 12 Months
Cost of interventions at 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | NHS Cost Differences at 12 Months | 508.69 UK Pounds | Standard Deviation 657.48 |
| Wrist Splint | NHS Cost Differences at 12 Months | 395.54 UK Pounds | Standard Deviation 596.47 |
95% CI: [-37.09, 279.21]Regression, Linear
Secondary
NHS Cost Differences at 24 Months
Cost of interventions at 24 months
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | NHS Cost Differences at 24 Months | 657.87 UK Pounds | Standard Deviation 808.57 |
| Wrist Splint | NHS Cost Differences at 24 Months | 586.77 UK Pounds | Standard Deviation 783.45 |
95% CI: [-120.84, 291.24]Regression, Linear
Secondary
NHS Cost Differences at 6 Months
Cost of interventions at 6 months
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | NHS Cost Differences at 6 Months | 346.78 UK Pounds | Standard Deviation 467.97 |
| Wrist Splint | NHS Cost Differences at 6 Months | 313.24 UK Pounds | Standard Deviation 480.84 |
95% CI: [-94.57, 145.59]Regression, Linear
Secondary
NHS Cost Differences at 6 Months (CC)
Complete case analysis on the cost of interventions at 6 months
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | NHS Cost Differences at 6 Months (CC) | 353.48 UK Pounds | Standard Deviation 512.85 |
| Wrist Splint | NHS Cost Differences at 6 Months (CC) | 306.42 UK Pounds | Standard Deviation 524.51 |
95% CI: [-104.84, 187.31]Regression, Linear
Secondary
Over the Counter Pain Medication 6 Months
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Over the Counter Pain Medication 6 Months | No | 82 Participants |
| Steroid Injection | Over the Counter Pain Medication 6 Months | Yes | 34 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months | No | 88 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months | Yes | 30 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.495% CI: [0.63, 3.18]Regression, Logistic
Secondary
Over the Counter Pain Medication 6 Months (CC)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Over the Counter Pain Medication 6 Months (CC) | No | 64 Participants |
| Steroid Injection | Over the Counter Pain Medication 6 Months (CC) | Yes | 16 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months (CC) | No | 66 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months (CC) | Yes | 17 Participants |
p-value: 0.5295% CI: [0.57, 3.06]Regression, Logistic
Secondary
Over the Counter Pain Medication 6 Months (PP)
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
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Over the Counter Pain Medication 6 Months (PP) | No | 65 Participants |
| Steroid Injection | Over the Counter Pain Medication 6 Months (PP) | Yes | 16 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months (PP) | No | 58 Participants |
| Wrist Splint | Over the Counter Pain Medication 6 Months (PP) | Yes | 15 Participants |
p-value: 0.6195% CI: [0.53, 2.95]Regression, Logistic
Secondary
Prescribed Pain Medication 6 Months
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Prescribed Pain Medication 6 Months | No | 96 Participants |
| Steroid Injection | Prescribed Pain Medication 6 Months | Yes | 20 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months | No | 106 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months | Yes | 12 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.295% CI: [0.7, 5.66]Regression, Logistic
Secondary
Prescribed Pain Medication 6 Months (CC)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Prescribed Pain Medication 6 Months (CC) | No | 70 Participants |
| Steroid Injection | Prescribed Pain Medication 6 Months (CC) | Yes | 12 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months (CC) | No | 79 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months (CC) | Yes | 7 Participants |
p-value: 0.1895% CI: [0.72, 5.78]Regression, Logistic
Secondary
Prescribed Pain Medication 6 Months (PP)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Prescribed Pain Medication 6 Months (PP) | No | 70 Participants |
| Steroid Injection | Prescribed Pain Medication 6 Months (PP) | Yes | 13 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months (PP) | No | 70 Participants |
| Wrist Splint | Prescribed Pain Medication 6 Months (PP) | Yes | 6 Participants |
p-value: 0.1495% CI: [0.77, 6.58]Regression, Logistic
Secondary
QALYS at 12 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | QALYS at 12 Months (Cross-walk Tariff) | 0.723 score on a scale | Standard Deviation 0.163 |
| Wrist Splint | QALYS at 12 Months (Cross-walk Tariff) | 0.736 score on a scale | Standard Deviation 0.156 |
95% CI: [-0.034, 0.027]Regression, Linear
Secondary
QALYS at 24 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | QALYS at 24 Months (Cross-walk Tariff) | 1.461 score on a scale | Standard Deviation 0.311 |
| Wrist Splint | QALYS at 24 Months (Cross-walk Tariff) | 1.497 score on a scale | Standard Deviation 0.301 |
95% CI: [-0.093, 0.045]Regression, Linear
Secondary
QALYS at 6 Months (Cross-walk Tariff)
The Quality Adjusted Life Years (QALYs) is a measure of the state of health of a person/group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment/intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life and freedom from pain and mental disturbance. The QALY does not have a maximum score. Cross-walk tariff: Crosswalk value sets were developed from a study of respondents who completed both the EQ-5D-3L and EQ-5D-5L. The crosswalk used a non-parametric response mapping method to predict values that are linked to the EQ-5D-3L value set. In short, the cross-walk tariff maps EQ-5D-5L values.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | QALYS at 6 Months (Cross-walk Tariff) | 0.354 score on a scale | Standard Deviation 0.093 |
| Wrist Splint | QALYS at 6 Months (Cross-walk Tariff) | 0.356 score on a scale | Standard Deviation 0.087 |
95% CI: [-0.01, 0.02]Regression, Linear
Secondary
Referral for Surgery 6 Weeks
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 weeks. Multiple imputation for missing data was performed 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.
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Referral for Surgery 6 Weeks | No | 112 Participants |
| Steroid Injection | Referral for Surgery 6 Weeks | Yes | 4 Participants |
| Wrist Splint | Referral for Surgery 6 Weeks | No | 113 Participants |
| Wrist Splint | Referral for Surgery 6 Weeks | Yes | 5 Participants |
Secondary
Referral to Surgery 6 Months
Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Referral to Surgery 6 Months | No | 94 Participants |
| Steroid Injection | Referral to Surgery 6 Months | Yes | 22 Participants |
| Wrist Splint | Referral to Surgery 6 Months | No | 104 Participants |
| Wrist Splint | Referral to Surgery 6 Months | Yes | 14 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.2395% CI: [0.73, 3.77]Regression, Logistic
Secondary
Referral to Surgery 6 Months (CC)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Referral to Surgery 6 Months (CC) | Yes | 16 Participants |
| Steroid Injection | Referral to Surgery 6 Months (CC) | No | 80 Participants |
| Wrist Splint | Referral to Surgery 6 Months (CC) | Yes | 11 Participants |
| Wrist Splint | Referral to Surgery 6 Months (CC) | No | 82 Participants |
p-value: 0.4195% CI: [0.61, 3.34]Regression, Logistic
Secondary
Referral to Surgery at 6 Months (PP)
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 surgery between treatment groups at 6 months follow-up on participants with complete data.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Referral to Surgery at 6 Months (PP) | No | 78 Participants |
| Steroid Injection | Referral to Surgery at 6 Months (PP) | Yes | 16 Participants |
| Wrist Splint | Referral to Surgery at 6 Months (PP) | No | 74 Participants |
| Wrist Splint | Referral to Surgery at 6 Months (PP) | Yes | 11 Participants |
p-value: 0.5295% CI: [0.57, 3.01]Regression, Logistic
Secondary
Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months
Comparison of overall BCTQ between treatment groups across all time points (6 weeks, 6-, 12-, and 24 month follow-up). Scale 1-5, higher score indicates more severe symptoms and functional impairment. Results are presented at 24 months. BCTQ: Boston Carpal Tunnel Questionnaire
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid Injection | Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months | 1.79 score on a scale | Standard Deviation 0.79 |
| Wrist Splint | Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months | 1.73 score on a scale | Standard Deviation 0.76 |
p-value: 0.5895% CI: [-0.16, 0.28]Mixed Models Analysis
Secondary
Surgery 6 Months
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Surgery 6 Months | No | 99 Participants |
| Steroid Injection | Surgery 6 Months | Yes | 17 Participants |
| Wrist Splint | Surgery 6 Months | No | 105 Participants |
| Wrist Splint | Surgery 6 Months | Yes | 13 Participants |
Comparison: The main treatment analyses were based on intention to treat approachp-value: 0.6695% CI: [0.41, 3.98]Regression, Logistic
Secondary
Surgery 6 Weeks
Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 weeks. Multiple imputation for missing data was performed 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.
Time frame: 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Steroid Injection | Surgery 6 Weeks | No | 114 Participants |
| Steroid Injection | Surgery 6 Weeks | Yes | 2 Participants |
| Wrist Splint | Surgery 6 Weeks | No | 116 Participants |
| Wrist Splint | Surgery 6 Weeks | Yes | 2 Participants |