Does intermittent splinting of post carpal tunnel surgery contribute to recovery?
| ISRCTN | ISRCTN67758087 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67758087 |
| Sponsor | University of Ottawa |
| Funder | The Ottawa hospital - Department of Surgery Internal Grant |
- Submission date
- 06/10/2026
- Registration date
- 12/10/2026
- Last edited
- 06/10/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Carpal tunnel syndrome is a common condition that can cause pain, numbness and tingling in the hand and wrist. Surgery can be used to relieve these symptoms. After surgery, there are different approaches to helping the hand and wrist recover. Some people may be encouraged to start moving their hand soon after surgery, while others may wear a splint for part of the day.
This study looked at whether wearing a splint for the first 2 weeks after carpal tunnel surgery helps recovery compared with starting active movement soon after surgery. The researchers compared symptoms, hand function and pain between the two approaches.
Who can participate?
Adults aged over 18 years with a diagnosis of carpal tunnel syndrome could take part if they were able to understand and answer the study questionnaires.
People could not take part if they were receiving workers' compensation, had injured their wrist within the previous 3 months, or had previously had carpal tunnel surgery on the same hand.
What does the study involve?
All participants had standard carpal tunnel release surgery under local anaesthetic. A total of 123 participants were randomly placed into one of two groups.
Participants in the early movement group received advice about wound care and exercises and were encouraged to start moving their hand after surgery.
Participants in the splint group were given a wrist splint with a metal insert to wear over their surgical dressing. They removed the splint each day to do their exercises and continued to use it until their follow-up visit 2 weeks after surgery. After this visit, their care was the same as for the early movement group.
Participants attended follow-up visits at 2, 6 and 12 weeks after surgery. At these visits, they completed questionnaires about their carpal tunnel symptoms and how well they could use their hand and arm. They also rated their level of pain.
What are the possible benefits and risks of participating?
Participants may have benefited from regular follow-up after their surgery. The study may also help researchers understand whether using a splint after carpal tunnel surgery improves recovery.
The study information does not provide details of specific risks from taking part. Wearing a splint may cause some inconvenience or discomfort, and participants in both groups had the usual risks associated with carpal tunnel surgery.
Where is the study run from?
University of Ottawa (Canada)
When is the study starting and how long is it expected to run for?
August 2009 to December 2016.
Who is funding the study?
The study was funded by an internal grant from the Department of Surgery at The Ottawa Hospital. The University of Ottawa was the study sponsor.
Who is the main contact?
Dr Blake Murphy, blake.murphy@unityhealth.to
Contact information
Principal investigator, Public, Scientific
St. Michael's Hospital
30 Bond Street, 4-080
Donnelly Wing
Toronto
M5B 1W8
Canada
| Phone | +1 (416) 864-6060 ext. 3868 |
|---|---|
| blake.murphy@unityhealth.to |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Compare early active mobilization versus Intermittent immobilization in post operative care of carpal tunnel surgery recipients |
| Study objectives | |
| Ethics approval(s) |
Approved 31/03/2009, Institutional research Ethics Board (Ottawa Hospital, Civic Campus, 725 Parkdale Avenue, Ottawa, K1Y4E9, Canada; no telephone number provided; REBAdministration@ohri.ca), ref: 2008813-01h |
| Health condition(s) or problem(s) studied | Use of splint for intermittent immobilization of the ipsilateral hand post carpal tunnel release surgery |
| Intervention | Randomization process - Sealed envelope; at the time participants consultation for surgery. Group A - Early active mobilization, the control group -> No active intervention, post surgery these individuals were advised on wound care, rehabilitation exercise and were followed at 2, 6, and 12 weeks Group B - Intermittent immobilization group - test group -> they were provided with a volar splint with metal insert to go on top of the surgical dressing, they were advised to remove it every day for rehabilitation exercise and continue wearing it till 2 week follow up. No difference in instructions with the control group in subsequent follow ups of 6 and 12 weeks |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Volar splint with metal insert |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 123 |
| Key inclusion criteria | 1. Clinical and electrophysiological diagnosis of carpal tunnel syndrome 2. Ability to comprehend and answer survey questions 3. Age greater than 18 years |
| Key exclusion criteria | 1. Workers compensation patients 2. History of recent (<3 months) wrist trauma 3. Prior ipsilateral carpal tunnel release |
| Date of first enrolment | 31/08/2009 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- Canada
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 06/10/2026 | No | No |
Additional files
- 50414 Protocol.pdf
- Protocol file
Editorial Notes
06/10/2026: Trial's existence confirmed by Ottawa Hospital.
