Prospective clinical trial comparing C-Trac™ splint with conventional resting splint for treatment of carpal tunnel syndrome
| ISRCTN | ISRCTN26618585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26618585 |
| Secondary identifying numbers | RD/33646/1, 06/Q2401/77 |
- Submission date
- 18/05/2006
- Registration date
- 22/06/2006
- Last edited
- 31/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Frank Burke
Scientific
Scientific
Pulvertaft Hand Centre
Derby Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
Study information
| Study design | Prospective randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | C-Trac |
| Study hypothesis | C-Trac™ is a safe and useful splint for treating carpal tunnel syndrome. |
| Ethics approval(s) | Derbyshire Research Ethics Committee, 18/08/2006, ref: 06/Q2401/77; Trust ref: DHRD/2006/037 |
| Condition | Carpal tunnel syndrome |
| Intervention | Comparing the C-Trac™ splint versus the conventional resting splint |
| Intervention type | Other |
| Primary outcome measure | Levine questionnaire scores in each group at 8 weeks |
| Secondary outcome measures | 1. Grip, pinch and sensation scores at 8 weeks 2. Levine questionnaire scores, grip, pinch and sensation scores at 0 and 4 weeks and at 6, 12, 24 and 60 months |
| Overall study start date | 22/06/2006 |
| Overall study end date | 21/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 patients in each group |
| Participant inclusion criteria | Patients less than 65 years of age presenting to the Pulvertaft Hand Centre with a diagnosis of mild or moderate carpal tunnel syndrome, confirmed by nerve conduction studies and clinical assessment |
| Participant exclusion criteria | 1. Severe carpal tunnel syndrome (based on nerve conduction studies and clinical assessment) 2. Previous carpal tunnel decompression on affected wrist 3. Previous steroid injection into affected carpal tunnel 4. 65 years of age or older 5. History of gout, hypothyroidism, previous fragility fracture, symptomatic basal joint arthritis, septic or rheumatoid arthritis of the hand, previous wrist fracture, diabetes mellitus, pregnancy, amyloidosis, acromegaly, renal dialysis, current oral steroid use 6. Current or very recent involvement in hand or related research 7. Regular use of hand-held vibrating tools 8. Ongoing involvement in compensation cases 9. Contact allergy to rubber or plastics 10. Patients who are unable to give informed consent |
| Recruitment start date | 22/06/2006 |
| Recruitment end date | 21/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pulvertaft Hand Centre
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Sponsor information
Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Assistant Director of Research and Development
Research and Development Office
Derby Hospitals National Health Service (NHS) Foundation Trust
University of Nottingham Medical School at Derby
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3DT
England
United Kingdom
Funders
Funder type
Industry
Heritage Medical Ltd. will initially contribute 25 C-Trac™ splints to the study, at a retail cost of £5000, and should C-Trac™ prove to be effective, further C-Trac™ splints will be provided.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/06/2013 | Yes | No |
