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 |
| Protocol serial number | RD/33646/1, 06/Q2401/77 |
| Sponsor | Derby Hospitals NHS Foundation Trust (UK) |
| Funder | 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. |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | C-Trac |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Carpal tunnel syndrome |
| Intervention | Comparing the C-Trac™ splint versus the conventional resting splint |
| Intervention type | Other |
| Primary outcome measure(s) |
Levine questionnaire scores in each group at 8 weeks |
| Key secondary outcome measure(s) |
1. Grip, pinch and sensation scores at 8 weeks |
| Completion date | 21/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/06/2006 |
| Date of final enrolment | 21/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Pulvertaft Hand Centre
Derby
DE1 2QY
United Kingdom
DE1 2QY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
