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| [ Print-friendly version ] |
| Splinting or surgery for carpal tunnel syndrome |
| ISRCTN | ISRCTN18853827 |
| ClinicalTrials.gov identifier | |
| Public title | Splinting or surgery for carpal tunnel syndrome |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | OG97-013 |
| Study hypothesis |
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 | The Medical Ethics Committees of the 13 participating hospitals approved the study protocol. |
| Study design | Randomised controlled trial |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Carpal tunnel syndrome |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 01/01/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 190 |
| Interventions |
1. Wrist splint
2. Open carpal tunnel release |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding |
1. Dutch Health Care Insurance Company (The Netherlands) (ref: OG 97-013)
2. Anna Fonds Foundation (The Netherlands) |
| Trial website | |
| Publications | 2001 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11801195 |
| Contact name | Ms Annette Gerritsen |
| Address |
EMGO-Institute
VU University Medical Centre Van der Boechorststraat 7 |
| City/town | Amsterdam |
| Zip/Postcode | 1081 BT |
| Country | Netherlands |
| Tel | +31 (0)20-444 8088 |
| Fax | +31 (0)20-4448181 |
| aam.gerritsen.emgo@med.vu.nl | |
| Sponsor | Dutch Health Care Insurance Company (The Netherlands) |
| Address | - |
| City/town | Amsterdam |
| Zip/Postcode | - |
| Country | Netherlands |
| Date applied | 11/02/2002 |
| Last edited | 11/09/2008 |
| Date ISRCTN assigned | 11/02/2002 |
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