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

The efficacy of wrist working splints on pain in rheumatoid arthritis patients with non-destructive wrist arthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27145
Enrollment
60
Registered
2006-03-27
Start date
2005-11-22
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis (RA) patients with arthritis of the wrist.

Interventions

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 w

Sponsors

University of Twente Department of Psychology and Communication of Health and Risk
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of RA according to the 1987 ACR criteria; 2. Stable DMARD therapy during preceding 3 months and no change expected for the next 4 weeks; 3. Stable symptomatic therapy (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 de past 24 hours (VAS score > 35 mm; 6. Age > 17 years.

Exclusion criteria

Exclusion criteria: 1. Unable to wear a wrist splint (by 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 (as there are 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.

Design outcomes

Primary

MeasureTime frame
Patients are measured twice: at baseline and after 4 weeks. Primary outcome measure is pain in the wrist (VAS 0 - 100 mm).

Secondary

MeasureTime frame
Secondary outcome measures are: 1. Pain in de 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.

Contacts

Public ContactM.M. Veehof

University Twente, Department of Psychology and Communication of Health and Risk, P.O. Box 217

m.m.veehof@utwente.nl+31 (0)53 4892939

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)