Evaluation of wrist splinting for the treatment of carpal tunnel syndrome
| ISRCTN | ISRCTN81836603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81836603 |
| Secondary identifying numbers | 2018/16 |
- Submission date
- 24/04/2018
- Registration date
- 02/05/2018
- Last edited
- 20/12/2024
- 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 pressure on a nerve in the wrist that causes tingling, numbness and pain in the hand and fingers. It is commonly treated with wrist splinting, mainly during night-time, but the evidence for the effectiveness and durability of this treatment is weak. The most common type of splint used in current clinical practice is a rigid splint that immobilizes the wrist. However, it has not been established whether a rigid splint is better than a soft splint that does not immobilize the wrist. The aim of this study is to assess the effectiveness of a rigid wrist splint compared with that of a soft wrist splint in patients with CTS.
Who can participate?
Patients aged 25 to 65 with CTS
What does the study involve?
Participants are randomly allocated to treatment with either a rigid or soft wrist splint to be used at night and if possible during daytime, at first for 6 weeks. The splints are fitted with a temperature monitoring device to measure the total time during which the splint has actually been worn. The participants complete a questionnaire that measures CTS symptoms, health status, quality of life and pain at the start of treatment and after 6, 12, 24 and 52 weeks. The participants undergo physical examinations and nerve conduction testing at the start of the study and at 52 weeks.
What are the possible benefits and risks of participating?
The results from the study are of great importance to patients who will be treated in the future for CTS. They will show the long-term effects of treatment of CTS with a wrist splint. The use of a wrist splint does not have any complications and participation in the study does not cause delayed treatment time compared with routine treatment.
Where is the study run from?
Department of Orthopedics, Hässleholm-Kristianstad-Ystad (Sweden)
When is the study starting and how long is it expected to run for?
January 2018 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Kamelia Tadjerbashi
Contact information
Scientific
J A Hedlunds väg 5
Kristianstad
29185
Sweden
Study information
| Study design | Multi-centre prospective assessor-blinded randomized clinical 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 patient information sheet |
| Scientific title | Treatment of carpal tunnel syndrome with wrist splinting: a randomized controlled trial |
| Study objectives | Wrist splinting is effective for treatment of carpal tunnel syndrome. |
| Ethics approval(s) | 1. Approved 30/01/2018, Regional Ethical Review Board (Lund, Sweden), ref: 2018/16 2. Amendment approved 16/02/2021, Ethical Review Authority (Sweden), ref: 2021-00656 |
| Health condition(s) or problem(s) studied | Carpal tunnel syndrome |
| Intervention | Current intervention as of 28/04/2021: A total of 112 eligible patients who accept participation and provide informed consent will be randomized according to a computer-generated list to treatment with either rigid or soft wrist splint to be used at night and if possible during daytime, initially for 6 weeks. Group A: Splint with metal bar A standard splint with wrist in neutral position worn at night and if possible during daytime. If after 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement, further treatment with splint is given for another 4 weeks. If the patient reports only small or no improvement after 10-week splinting the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery. Surgery will not be performed before 12 weeks after treatment start. If symptom recurrence occurs after improvement, the patients will be offered 4 weeks of wrist splinting. If the patient reports small or no improvement the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery. Group B: Soft splint The splint is worn at night and if possible during daytime. If at the end of the 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement the patient is offered surgery. Surgery will not be performed before 12 weeks after treatment start. If the patients reports symptom recurrence the patient will receive 4 weeks of similar splint. If the patient reports small or no improvement the patient is offered surgery. The splints will be fitted with a temperature monitoring device to ascertain the total time during which the splint has actually been worn. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale, the Euro-Qol 5-dimentions (EQ-5D) health status and quality of life measure and the palmar pain scale at trial start and at 6, 12, 24 and 52 weeks after treatment start. The participants will undergo physical examination and nerve conduction testing at trial start and at 52 weeks. The trials primary outcome is the change in the CTS-6 score from trial start, to 6 and 12 weeks and the rate of carpal tunnel release surgery at 52 weeks. From patient 113 and onwards, the randomization process and interventions will be exactly the same as described above, however, the trial participants will complete the questionnaire only at baseline, and at 6 and 12 weeks after treatment start, since the follow-up time for these patients be 12 weeks (time frame for the trial’s first primary outcome measure). Patient 113 and onwards will undergo physical examination and nerve conduction testing at trial start but not at 52 weeks. No other changes will be made in the trial protocol for these patients. _____ Previous intervention: A total of 112 eligible patients who accept participation and provide informed consent will be randomized according to a computer-generated list to treatment with either rigid or soft wrist splint to be used at night and if possible during daytime, initially for 6 weeks. Group A: Splint with metal bar A standard splint with wrist in neutral position worn at night and if possible during daytime. If after 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement, further treatment with splint is given for another 4 weeks. If the patient reports only small or no improvement after 10-week splinting the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery. Surgery will not be performed before 12 weeks after treatment start. If symptom recurrence occurs after improvement, the patients will be offered 4 weeks of wrist splinting. If the patient reports small or no improvement the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery. Group B: Soft splint The splint is worn at night and if possible during daytime. If at the end of the 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement the patient is offered surgery. Surgery will not be performed before 12 weeks after treatment start. If the patients reports symptom recurrence the patient will receive 4 weeks of similar splint. If the patient reports small or no improvement the patient is offered surgery. The splints will be fitted with a temperature monitoring device to ascertain the total time during which the splint has actually been worn. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale, the Euro-Qol 5-dimentions (EQ-5D) health status and quality of life measure and the palmar pain scale at trial start and at 6, 12, 24 and 52 weeks after treatment start. The participants will undergo physical examination and nerve conduction testing at trial start and at 52 weeks. The trials primary outcome is the change in the CTS-6 score from trial start, to 6 and 12 weeks and the rate of carpal tunnel release surgery at 52 weeks. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 1. Change in CTS symptoms, measured with the 6-item CTS symptoms scale at baseline, 6 weeks and 12 weeks 2. Rate of surgery at 52 weeks, measured in percent (proportion of patients that had surgery within 52 weeks) |
| Secondary outcome measures | 1. TS symptoms, measured with the 6-item CTS symptoms scale score at 52 weeks 2. Activity limitations, measured with the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale score at baseline, 12 weeks and 52 weeks 3. Health status and quality of life, measured with the EQ-5D index at baseline, 12 weeks and 52 weeks 4. Grip strength, measured with the Jamar dynamometer at baseline and 52 weeks 5. Patient satisfaction, measured with the visual analogue scale (VAS) at 12 weeks and 52 weeks 6. Palmar pain, measured with the 2-item palmar pain scale at 52 weeks 7. Time to surgery, measured in weeks, within 52 weeks 8. Duration of sick leave, measured in days/weeks/months during 52 weeks 9. Adverse events |
| Overall study start date | 02/01/2018 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 112 |
| Total final enrolment | 142 |
| Key inclusion criteria | Current inclusion criteria as of 04/06/2018: 1. Primary, idiopathic carpal tunnel syndrome (CTS) 2. Age 25-65 years, either sex 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS 5. Symptom duration of at least 1 month Previous inclusion criteria: 1. Primary, idiopathic carpal tunnel syndrome (CTS) 2. Age 25-65 years, either sex 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS 5. Symptom duration of at least 1 month 6. Symptom severity score at least 1.8 on the 6-item CTS symptoms scale (CTS-6) |
| Key exclusion criteria | 1. CTS classified as severe (thenar atrophy or 2-point discrimination exceeding 8 mm in at least 1 finger) 2. Treatment of the study hand with a wrist splint in the past year 3. Previous steroid injection for CTS in the study hand 4. Inflammatory joint disease 5. Vibration-induced neuropathy 6. Polyneuropathy 7. Current pregnancy 8. Trauma to the study hand in the past year 9. Previous CTS surgery in the study hand 10. Inability to complete questionnaires due to language difficulties or cognitive disorder 11. Severe medical illness 12. Known abuse of drugs and/or alcohol |
| Date of first enrolment | 04/06/2018 |
| Date of final enrolment | 21/12/2021 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Sweden
Sponsor information
Hospital/treatment centre
VO Ortopedi, Skånevård Kryh
Hässleholm
28125
Sweden
"ROR" |
https://ror.org/03sawy356 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The trialists intend to publish the study protocol with statistical analysis plan in an appropriate journal during 2018. Planned publication of the study results in a high-impact peer reviewed journal. |
| IPD sharing plan | Current individual participant data (IPD) sharing statement as of 05/01/2022: The datasets generated and analysed during the current study are not expected to be made available as the study team do not have ethical approval or participant consent for making individual patient data publicly available. Previous individual participant data (IPD) sharing statement: The trialists are not allowed to share individual patient data but can consider reasonable requests from researchers. The data will be stored at the trial researchers’ institution. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/08/2019 | 29/08/2019 | Yes | No |
Editorial Notes
20/12/2024: The intention to publish date was changed from 30/06/2024 to 01/01/2025.
12/10/2023: The intention to publish date was changed from 31/10/2023 to 30/06/2024.
07/07/2023: The intention to publish date was changed from 30/06/2023 to 31/10/2023.
05/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 21/12/2021.
2. The overall trial end date has been changed from 31/03/2022 to 31/12/2022 and the plain English summary has been updated to reflect this change.
3. The total final enrolment number has been added.
4. The individual participant data (IPD) sharing statement has been updated and the IPD sharing summary has been changed from "Other" to "Not expected to be made available".
28/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 31/12/2021.
2. The overall trial end date has been changed from 30/06/2023 to 31/03/2022.
3. An amendment approval has been added to the ethics approval.
4. The intervention has been changed.
5. The intention to publish date has been changed from 30/06/2024 to 30/06/2023.
29/08/2019: Publication reference added.
21/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 30/06/2022.
2. The overall trial end date was changed from 31/05/2020 to 30/06/2023.
3. The intention to publish date was changed from 30/05/2020 to 30/06/2024.
04/06/2018: The following changes have been made:
1. The recruitment start date has been changed from 02/05/2018 to 04/06/2018.
2. The participant inclusion criteria have been changed.
