Splinting or surgery for carpal tunnel syndrome
| ISRCTN | ISRCTN18853827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18853827 |
| Secondary identifying numbers | OG97-013 |
- Submission date
- 11/02/2002
- Registration date
- 11/02/2002
- Last edited
- 27/10/2022
- 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
Ms Annette Gerritsen
Scientific
Scientific
EMGO-Institute
VU University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20-444 8088 |
|---|---|
| aam.gerritsen.emgo@med.vu.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Splinting or surgery for carpal tunnel syndrome |
| Study objectives | 1. To determine the short and long-term efficacy of splinting compared with early surgery in relieving Carpal Tunnel Syndrome (CTS) symptoms 2. To assess from a societal perspective the cost-effectiveness of these treatment options |
| Ethics approval(s) | The Medical Ethics Committees of the 13 participating hospitals approved the study protocol. |
| Health condition(s) or problem(s) studied | Carpal tunnel syndrome |
| Intervention | 1. Wrist splint 2. Open carpal tunnel release |
| Intervention type | Other |
| Primary outcome measure | 1. General improvement, scored by the patient on a 6-point ordinal transition scale, ranging from 'completely recovered' to 'much worse' 2. The number of nights that the patient awoke, due to the symptoms, during the past week 3. The severity of the most important symptoms In order to study short and long-term treatment effects, data are collected in the hospital at baseline and at 3, 6 and 12 months after randomisation. Additional postal questionnaires are sent to the patients in the months that they do not visit the hospital (1, 2, 4, 5, 7, 8, 9, 10 and 11 months after randomisation), and again 18 months after randomisation. |
| Secondary outcome measures | 1. Patient satisfaction, using an 11-point numerical rating scale, ranging from 0 'very unsatisfied' to 10 'completely satisfied' 2. Use of pain medication for the symptoms during the past week (yes/no) 3. The severity of symptoms and functional status, assessed by means of a self-administered questionnaire, containing two scales (the Symptom Severity Scale and the Functional Status Scale) 4. The overall severity of CTS complaints 5. Results of electrodiagnostic studies Other outcome measures: 1. Compliance with treatment 2. Adverse effects 3. Direct and indirect costs 4. Success of blinding In order to study short and long-term treatment effects, data are collected in the hospital at baseline and at 3, 6 and 12 months after randomisation. Additional postal questionnaires are sent to the patients in the months that they do not visit the hospital (1, 2, 4, 5, 7, 8, 9, 10 and 11 months after randomisation), and again 18 months after randomisation. |
| Overall study start date | 01/01/2002 |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 190 |
| Total final enrolment | 176 |
| Key inclusion criteria | 1. Pain, paraesthesias and/or hypoesthesias in the hand, in the area innervated by the median nerve 2. Clinical diagnosis of CTS has to be confirmed by electrodiagnostic studies 3. Aged 18 years or older 4. Able to complete written questionnaires (in Dutch) |
| Key exclusion criteria | 1. Already been treated with a wrist splint or have had previous carpal tunnel release 2. A history of wrist or median nerve injury from trauma (e.g. contusion, fractures) or prior surgery on the wrist 3. A history suggesting underlying causes of CTS, such as diabetes mellitus, thyroid disease, rheumatoid arthritis, chronic renal failure treated by hemodialysis, space-occupying lesions in the volar wrist area, anatomic abnormalities of the wrist or hand 4. Pregnancy or lactation 5. Clinical signs or symptoms, or electrodiagnostic studies suggesting conditions that could mimic CTS or interfere with its validation, such as cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome, pronator teres syndrome, ulnar neuropathy, polyneuropathy, Raynaud's disease or sympathetic dystrophy 6. Severe thenar muscle atrophy |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
EMGO-Institute
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Dutch Health Care Insurance Company (The Netherlands)
Government
Government
-
Amsterdam
-
Netherlands
Funders
Funder type
Government
Dutch Health Care Insurance Company (The Netherlands) (ref: OG 97-013)
No information available
Anna Fonds Foundation (The Netherlands)
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 18/12/2001 | Yes | No | ||
| Results article | 11/09/2002 | 27/10/2022 | Yes | No |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
