The efficacy of wrist working splints in patients with non-destructive wrist arthritis

ISRCTN	ISRCTN22172654
DOI	https://doi.org/10.1186/ISRCTN22172654
Protocol serial number	NL586 (NTR642)
Sponsor	University of Twente, Department of Psychology and Communication of Health and Risk (PCGR) (The Netherlands)
Funder	Stichting ReumaOnderzoek Twente (The Netherlands)

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 of protocol

Not provided at time of registration

Contact information

Dr M.M. Veehof
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
Email	m.m.veehof@utwente.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The efficacy of wrist working splints in patients with non-destructive wrist arthritis
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	Patients are measured twice: at baseline and after 4 weeks. Primary outcome measure is pain in the wrist (VAS 0-100 mm).
Key secondary outcome measure(s)	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
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	22/11/2005
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Twente

Enschede
7500 AE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.