Condition category
Musculoskeletal Diseases
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
11/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.M. Veehof

ORCID ID

Contact details

University Twente
Department of Psychology and Communication of Health and Risk
P.O. Box 217
Enschede
7500 AE
Netherlands
+31 (0)53 4892939
m.m.veehof@utwente.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

22/11/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

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

Trial participating centre

University Twente
Enschede
7500 AE
Netherlands

Sponsor information

Organisation

University of Twente, Department of Psychology and Communication of Health and Risk (PCGR) (The Netherlands)

Sponsor details

P.O. Box 217
Enschede
7500 AE
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Stichting ReumaOnderzoek Twente (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes