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| ID | Type | Description | Link |
|---|---|---|---|
| 20105 | Other Grant/Funding Number | Arthritis Research UK | |
| 2013-001435-48 | EudraCT Number | ||
| 13/NW/0280 | Other Identifier | UK NHS Research Ethics Committee | |
| 09392969 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| Arthritis Research UK | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid Injection | Active Comparator | Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) |
|
| Wrist Splint | Active Comparator | Wrist splint to be worn at night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depo-Medrone | Drug | Steroid Injection |
| |
| Wrist Splint |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| BCTQ Functional Limitations Subscale 6 Weeks |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Edward Roddy, Fellow RCP | Keele University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Staffordshire and Stoke on Trent Partnership NHS Trust | Newcastle-under-Lyme | Staffordshire | ST5 1QG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716159 | Background | Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415. doi: 10.1186/s12891-016-1264-8. | |
| 30343858 |
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Keele University is a member of the UK Reproducibility Network and committed to the principles of the UK Concordat on Open Research Data. The School of Medicine and Keele Clinical Trials Unit have a longstanding commitment to sharing data from our studies to improve research reproducibility and to maximise benefits for patients, the wider public, and the health and care system. We encourage collaboration with those who collected the data, to recognise and credit their contributions.
The School of Medicine and Keele Clinical Trials Unit make data available to bona-fide researchers upon reasonable request via open or restricted access through a strict controlled access procedure. The release of data may be subject to a data use agreement (DUA) between the Sponsor and the third party requesting the data. In the first instance, data requests and enquiries should be directed to medicine.datasharing@keele.ac.uk.
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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.
Patients were recruited from 25 General Practices and community musculoskeletal clinics between 17/04/2014 and 31/12/2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid Injection | Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) Depo-Medrone: Steroid Injection |
| FG001 | Wrist Splint | Wrist splint to be worn at night Wrist Splint: Simple wrist splint |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid Injection | Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) Depo-Medrone: Steroid Injection |
| BG001 | Wrist Splint | Wrist splint to be worn at night Wrist Splint: Simple wrist splint |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
24 months
Reporting by investigators. Expected related adverse events self-reported by participants in 6-week questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroid Injection | Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg) Depo-Medrone: Steroid Injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment | Open comminuted fracture left middle finger, operative fixation with K-wires |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
Trial participants and clinicians were not masked to treatment allocation. We recruited six short of the target 240 participants; however, statistical power was retained because of higher than anticipated follow-up rates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Edward Roddy | Keele University | 01782 734715 | e.roddy@keele.ac.uk |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Device |
Simple wrist splint |
|
|
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 |
| 6 weeks |
| 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). | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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 | 6 months |
| 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 | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Referral to Surgery 6 Months | Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. | 6 months |
| Surgery 6 Months | Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months. | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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 | 6 weeks |
| 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. | 6 months |
| 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. | 12 months |
| 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 | 24 months |
| 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. | 6 weeks |
| 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. | 6 months |
| 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. | 12 months |
| 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. | 24 months |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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 | 6 months |
| 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 | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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 | 6 months |
| 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 | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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 | 6 months |
| 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. | 6 months |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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 | 6 weeks |
| 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 | 6 weeks |
| NHS Cost Differences at 6 Months | Cost of interventions at 6 months | 6 months |
| NHS Cost Differences at 6 Months (CC) | Complete case analysis on the cost of interventions at 6 months | 6 months |
| NHS Cost Differences at 12 Months | Cost of interventions at 12 months | 12 months |
| NHS Cost Differences at 24 Months | Cost of interventions at 24 months | 24 months |
| 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. | 6 months |
| 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. | 12 months |
| 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. | 24 months |
| Result |
| Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| First time diagnosed with carpal tunnel syndrome | Count of Participants | Participants |
|
| Number of times previously had carpal tunnel syndrome | Count of Participants | Participants |
|
| Hand or wrist previously affected by carpal tunnel syndrome | Count of Participants | Participants |
|
| Treatment for previous carpal tunnel syndrome | Participants may select more than one treatment. | Number | participants |
|
| Steroid injection into a joint other than wrist if previously had carpal tunnel syndrome | Count of Participants | Participants |
|
| Usefulness of injection into other joint if previously had carpal tunnel syndrome | Count of Participants | Participants |
|
| Which problematic hand or wrist | Count of Participants | Participants |
|
| If both hands problematic, which hand was worse | Count of Participants | Participants |
|
| Dominant hand | Count of Participants | Participants |
|
| Duration of hand or wrist problems | Count of Participants | Participants |
|
| How did your hand or wrist problems start | Count of Participants | Participants |
|
| Particular position causes hand or wrist problems | Count of Participants | Participants |
|
| Curently taking pain relief | Count of Participants | Participants |
|
| Number of times a day taking pain relief | Count of Participants | Participants |
|
| Number of days per week taking pain relief | Count of Participants | Participants |
|
| Number of weeks in a month taking pain relief | Count of Participants | Participants |
|
| In a current paid job | Count of Participants | Participants |
|
| If not in a current paid job, describe current position | Participants may select more than one option | Number | participants |
|
| Typical weekly working hours | Count of Participants | Participants |
|
| Describes current situation in respect of your job | Count of Participants | Participants |
|
| If not doing usual job/annual leave, is this due to your hand or wrist problems | Count of Participants | Participants |
|
| Taken time off work during the last 6 months for your hand or wrist problems | Count of Participants | Participants |
|
| I feel my welfare is important to my employer | Count of Participants | Participants |
|
| Which treatment would you prefer | Count of Participants | Participants |
|
| If you had received wrist injection, would you expect your symptoms to improve | Count of Participants | Participants |
|
| If you received night splint, would you expect your symptoms to improve | Count of Participants | Participants |
|
| My hand or wrist problem will last for a long time | Count of Participants | Participants |
|
| My hand or wrist problem has major consequences on my life | Count of Participants | Participants |
|
| There is a lot that I can do to control my hand or wrist problems | Count of Participants | Participants |
|
| What I can do determines whether my hand or wrist problems gets better or worse | Count of Participants | Participants |
|
| Treatment can control my hand or wrist problem | Count of Participants | Participants |
|
| My hand or wrist problem affects me emotionally | Count of Participants | Participants |
|
| Been bother by feeling down, depressed or hopeless | Count of Participants | Participants |
|
| Been bothered by little interest or pleasure in doing things | Count of Participants | Participants |
|
| Diagnosed with hypothyroidism | Count of Participants | Participants |
|
| Diagnosed with diabetes | Count of Participants | Participants |
|
| Any other conditions affecting neck, shoulders or elbows | Count of Participants | Participants |
|
| Had pain anywhere else | Count of Participants | Participants |
|
| Last time you were free of pain | Count of Participants | Participants |
|
| On average, how often do you drink alcohol | Count of Participants | Participants |
|
| What is your current smoking status | Count of Participants | Participants |
|
| Has insomnia due to hand or wrist problem | Participants were asked four questions how hand and wrist problems affects their sleep. Participants reporting hand and wrist problems affects their sleep on most nights on one or more questions were deemed to have insomnia. Based on multiply imputed data. | Count of Participants | Participants |
|
| To what extent have hand or wrist problems affected your performance at work over the past month | 0-10 scale; 0=not at all, 10=unable to do job | Mean | Standard Deviation | units on a scale |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Boston carpal tunnel symptom severity and functional limitations | Scale 1-5, higher scores indicate more symptom severity and functional limitations. Analysis is based on multiply imputed data. | Mean | Standard Deviation | units on a scale |
|
| Boston carpal tunnel symptom severity subscale | Scale 1-5, higher scores indicate more severe symptoms. Analysis is based on multiply imputed data. | Mean | Standard Deviation | units on a scale |
|
| Boston carpal tunnel functional limitations subscale | Scale 1-5, higher scores indicate more severe functional impairment. Analysis is based on multiply imputed data. | Mean | Standard Deviation | units on a scale |
|
| Hand-wrist pain intensity | 0-10 scale, higher scores indicating more pain. Analysis is based on multiply imputed data. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Referral to Surgery 6 Months | Participants were asked if they were referred for surgery (carpal tunnel decompression) in the last 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Surgery 6 Months | Participants were asked if they had surgery for carpal tunnel syndrome in the last 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
|
| Secondary | NHS Cost Differences at 6 Months | Cost of interventions at 6 months | Posted | Mean | Standard Deviation | UK Pounds | 6 months |
|
|
|
|
| Secondary | NHS Cost Differences at 6 Months (CC) | Complete case analysis on the cost of interventions at 6 months | Posted | Mean | Standard Deviation | UK Pounds | 6 months |
|
|
|
|
| Secondary | NHS Cost Differences at 12 Months | Cost of interventions at 12 months | Posted | Mean | Standard Deviation | UK Pounds | 12 months |
|
|
|
|
| Secondary | NHS Cost Differences at 24 Months | Cost of interventions at 24 months | Posted | Mean | Standard Deviation | UK Pounds | 24 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 months |
|
|
|
|
| 2 |
| 116 |
| 3 |
| 116 |
| 57 |
| 116 |
| EG001 | Wrist Splint | Wrist splint to be worn at night Wrist Splint: Simple wrist splint | 0 | 118 | 4 | 118 | 7 | 118 |
|
| Other | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Cardiac failure NB No specific adverse event term for this AE in CTCAE 4.0. Adverse event recorded as 'other' & AE Term Additional Description provided, aligning with trial EudraCT entry. |
|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Other | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Cryptogenic organising pneumonia NB No specific adverse event term for this AE in CTCAE 4.0. Adverse event recorded as 'other' & AE Term Additional Description provided, aligning with trial EudraCT entry. |
|
| Other | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Patella resurfacing NB No specific adverse event term for this AE in CTCAE 4.0. Adverse event recorded as 'other' & AE Term Additional Description provided, aligning with trial EudraCT entry. |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Total arthroplasty for osteoarthritis (one hip, one knee) |
|
| Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Thinning, lightening or darkening of skin at injection site |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | For steroid injection, hand or wrist was more painful following injection. For splinting, participants unable to wear splint because of discomfort. |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Missing |
|
| 2 |
|
| 3 |
|
| More than 3 |
|
| Missing |
|
| Left |
|
| Both |
|
| Missing |
|
| No |
|
| Missing |
|
| Of some help |
|
| Of little help |
|
| Of no help |
|
| Missing |
|
| Both |
|
| Missing |
|
| Left |
|
| No difference |
|
| Missing |
|
| Missing |
|
| 6 months-1 year |
|
| >1 year |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| Missing |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| 7 |
|
| Missing |
|
| 2 |
|
| 3 |
|
| 4 |
|
| Missing |
|
| Missing |
|
| Part time |
|
| Missing |
|
| On paid annual leave/holiday |
|
| Working fewer hours |
|
| Doing lighter duties |
|
| On paid sick leave |
|
| On unpaid sick leave |
|
| Missing |
|
| No |
|
| Missing |
|
| No |
|
| Missing |
|
| Disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| No preference |
|
| Somewhat prefer night splints |
|
| Strongly prefer night splints |
|
| Missing |
|
| Not sure |
|
| Missing |
|
| Not sure |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Neither agree nor disagree |
|
| Agree |
|
| Strongly agree |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| 6 months-1 year ago |
|
| 1-3 years ago |
|
| >3 years ago |
|
| Missing |
|
| Once or twice a month |
|
| Once or twice a year |
|
| Never |
|
| Missing |
|
| Current smoker |
|
| Missing |
|