The efficacy of wrist working splints in patients with non-destructive wrist arthritis.
Completed
- Conditions
- Rheumatoid arthritis (RA) patients with arthritis of the wrist.
- Registration Number
- NL-OMON27145
- Lead Sponsor
- niversity of TwenteDepartment of Psychology and Communication of Health and Risk
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients are measured twice: at baseline and after 4 weeks. <br><br /><br /><br>Primary outcome measure is pain in the wrist (VAS 0 - 100 mm).
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are:<br /><br>1. Pain in de wrist (box scale 0 - 10);<br /><br>2. Number of painful and swollen joints in the hand (joint count max score 11 and Ritchie scale (max score 33);<br /><br>3. Synovitis (ultrasound);<br /><br>4. Grip strength;<br /><br>5. Dexterity (SODA, DASH);<br /><br>6. Patient's subjective judgement about the effect of the splint on pain, swelling, grip strength and hand function.