The efficacy of wrist working splints in patients with non-destructive wrist arthritis
| ISRCTN | ISRCTN22172654 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22172654 |
| Secondary identifying numbers | NL586 (NTR642) |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr M.M. Veehof
Scientific
Scientific
University Twente
Department of Psychology and Communication of Health and Risk
P.O. Box 217
Enschede
7500 AE
Netherlands
| Phone | +31 (0)53 4892939 |
|---|---|
| m.m.veehof@utwente.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | The efficacy of wrist working splints in patients with non-destructive wrist arthritis |
| Study hypothesis | We expect a reduction of pain in the wrist, measured with a Visual Analogue Scale (VAS), after 4 weeks of wrist working splint wearing, and a difference in pain score between the experimental group (splinting intervention as adjuvant to usual treatment) and the control group (usual treatment). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Condition | Rheumatoid arthritis, arthritis of the wrist |
| Intervention | Patients are randomly allocated to the experimental group (splinting intervention as adjuvant to usual treatment) or the control group (usual treatment). Patients in the experimental group receive a wrist working splint for their most painful hand. The splint is fitted by an occupational therapist who also gives education on splint wearing. To optimize compliance with splint wearing, compliance enhancing measures are included in this education. Patients are asked to wear the splint by day as much as possible (especially during activities) for four weeks. |
| Intervention type | Other |
| Primary outcome measure | Patients are measured twice: at baseline and after 4 weeks. Primary outcome measure is pain in the wrist (VAS 0-100 mm). |
| Secondary outcome measures | 1. Pain in the wrist (box scale 0-10) 2. Number of painful and swollen joints in the hand (joint count max score 11 and Ritchie scale max score 33) 3. Synovitis (ultrasound) 4. Grip strength 5. Dexterity (SODA, DASH) 6. Patient's subjective judgement about the effect of the splint on pain, swelling, grip strength and hand function |
| Overall study start date | 22/11/2005 |
| Overall study end date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Diagnosis of RA according to the 1987 ACR criteria 2. Stable disease modifying anti-rheumatic drug (DMARD) therapy during preceding 3 months and no change expected for the next 4 weeks 3. Stable symptomatic therapy (non-steroidal anti-inflammatory drugs [NSAIDs] and corticosteroids) during preceding 2 weeks and no change expected for the next 4 weeks 4. Active arthritis of the wrist due to RA (clinical judgement rheumatologist) 5. Painful wrist over the past 24 hours (VAS score >35 mm) 6. Age >17 years |
| Participant exclusion criteria | 1. Unable to wear a wrist splint (due to a rash, allergies etc.) 2. An injection of corticosteroid medication in the wrist or any small joints of the hand or flexor tendon sheath of the hand within the preceding 1 month or the expectation that such an injection will be indicated in the next 4 weeks 3. Carpal tunnel syndrome 4. Deformities of wrist (any [sub]luxation, any deviation) and/or fingers (e.g. MCP ulnar drifts, swan neck deformities, boutonniere deformities, subluxations thumb) 5. History of jint surgery of the wrist 6. Use of a wrist orthesis during the 2 weeks prior to participation in the study 7. Steinbrocker functional classification of 4 8. Difficulties with the Dutch language |
| Recruitment start date | 22/11/2005 |
| Recruitment end date | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Twente
Enschede
7500 AE
Netherlands
7500 AE
Netherlands
Sponsor information
University of Twente, Department of Psychology and Communication of Health and Risk (PCGR) (The Netherlands)
University/education
University/education
P.O. Box 217
Enschede
7500 AE
Netherlands
"ROR" |
https://ror.org/006hf6230 |
|---|
Funders
Funder type
Research organisation
Stichting ReumaOnderzoek Twente (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 |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
