The effectiveness of splinting for the treatment of carpal tunnel syndrome
| ISRCTN | ISRCTN13189602 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13189602 |
- Submission date
- 01/11/2022
- Registration date
- 02/11/2022
- Last edited
- 30/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Carpal tunnel syndrome (CTS) is among the most frequent nerve disorders of the arm. Occupational therapists typically treat CTS conservatively by splinting the wrist, but the success of this treatment is not well-researched. The aim of this study is to evaluate the effectiveness of splinting the wrist with a modified splint which supports the wrist and the fingers, in the treatment of carpal tunnel syndrome.
Who can participate?
Patients aged 18 years and over with carpal tunnel syndrome
What does the study involve?
This study involves basic measurements before and after the use of the splint. An occupational therapist will assess the hand’s strength, sensation, and movement, and then will fit the hand with a splint to support the wrist and fingers for 6 weeks to relieve the symptoms of the condition.
What are the possible benefits and risks of participating?
The study will help us understand if splinting the wrist and fingers is effective in treating carpal tunnel syndrome. The treatment is conservative, and no harm or unintended effects are foreseen. Confidentiality is assured, and all the information gathered in this study will be kept with the researcher.
Where is the study run from?
Kuwait University (Kuwait)
When is the study starting and how long is it expected to run for?
January 2018 to February 2023
Who is funding the study?
Kuwait University (Kuwait)
Who is the main contact?
Dr Mohammed Sh. Nadar, mohammed.nadar@ku.edu.kw
Contact information
Principal Investigator
Occupational Therapy Department
Faculty of Allied Health Sciences
Kuwait University
Jabriah
00000
Kuwait
 ORCID ID |
0000-0003-4281-5630 |
|---|---|
| Phone | +965 (0)24633491 |
| mohammed.nadar@ku.edu.kw |
Study information
| Study design | Multicenter interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Efficacy of splinting the wrist and metacarpophalangeal joints for the treatment of carpal tunnel syndrome |
| Study objectives | The purpose of this assessor-blinded study is to compare the effectiveness of traditional cock-up splints (which restrict the wrist in neutral) with customized splints (which restrict the wrist and the metacarpophalangeal [MCP] joints of the medial four digits in neutral) in the treatment of mild-to-moderate carpal tunnel syndrome. The hypotheses are: (1) the splinting treatment will reduce CTS symptoms and improve functional status in patients with mild-to-moderate CTS in both groups; and (2) the group that receives the splint that supports the wrist and MCP will show better outcome (i.e., more reduction in symptom severity and more improvement in functional status) than the group that will receive the traditional wrist cock-up splint. |
| Ethics approval(s) | Approved 08/10/2018, Health Sciences Center Ethical Committee - Kuwait University (Centre for Research Support & Conferences, Office of the Vice Dean for Research & Postgraduate Studies, HSC, Faculty of Medicine, PO Box 24923, Safat 13110, Kuwait; +965 (0)24634524; hsc.ethicalcommitee@ku.edu.kw), ref: VDR/EC/3410 |
| Health condition(s) or problem(s) studied | Carpal tunnel syndrome |
| Intervention | The study includes 60 participants with mild to moderate carpal tunnel syndrome. A simple randomization procedure of computer-generated random numbers is used to randomize the participants into two groups: an experimental group that is fitted with an MCP splint to support the wrist and MCP joints (the splint will position the wrist in neutral (0°) and the MCP joints in 20° of flexion), and a control group that will receive a traditional wrist splint, which will be fabricated to support the wrist in neutral (0°) position and with no finger restrictions. Both groups will follow the same treatment plan and wearing schedule. All the participants will be instructed to wear splints all day and night for 4 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Metacarpophalangeal (MCP) splint, MCP joints, traditional wrist splint |
| Primary outcome measure | 1. Symptoms severity and functional status measured using the Levine-Katz (Boston) Carpal Tunnel Syndrome Questionnaire at baseline, 6 weeks, and 3 months 2. Grip strength measured using hand-held dynamometer at baseline, 6 weeks, and 3 months 3. Two-point discrimination sensation measured using the Disk-Criminator tool at baseline, 6 weeks, and 3 months 4. Touch sensibility threshold measured using Semmes Weinstein monofilaments at baseline, 6 weeks, and 3 months |
| Secondary outcome measures | Tingling sensation measured using the Phalen’s test and the Tinel’s sign test at baseline, 6 weeks, and 3 months |
| Overall study start date | 10/01/2018 |
| Completion date | 20/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Adults (aged 18 years and over) with confirmed diagnoses of mild to moderate CTS |
| Key exclusion criteria | 1. Neuropathy (e.g., diabetes mellitus or thyroid disease) other than CTS in the past year 2. Pregnancy 3. Had a steroid injection into the carpal canal in the past 3 months 4. Receive a steroid injection during the time of the study |
| Date of first enrolment | 05/11/2022 |
| Date of final enrolment | 05/02/2023 |
Locations
Countries of recruitment
- Kuwait
Study participating centre
Fourth Ring Rd
Jabriya
00000
Kuwait
Sponsor information
University/education
4th Ring Road
Jabriah
00000
Kuwait
| Phone | +965 (0)24633489 |
|---|---|
| naser.alotaibi@ku.edu.kw | |
| Website | http://www.kuniv.edu/ku |
"ROR" |
https://ror.org/021e5j056 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- KU
- Location
- Kuwait
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from the first author (Mohammed Nadar, mohammed.nadar@ku.edu.kw) The type of data that will be shared: raw data in Excel or SPSS Timing for availability: after study completion (estimated time is March 2023) Whether consent from participants was required and obtained: Yes, consent is required and will be obtained from all participants. Comments on data anonymization: The data is anonymous, and will not contain identifying information of participants Any ethical or legal restrictions: Ethical approval was obtained. The data to be shared has no ethical or legal restrictions |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 28/11/2023 | 30/11/2023 | Yes | No |
Editorial Notes
30/11/2023: Publication reference added.
13/03/2023: The intention to publish date has been changed from 01/03/2023 to 01/09/2023.
02/11/2022: Trial's existence confirmed by the Health Sciences Center Ethical Committee - Kuwait University.
