Abstract

Research objective: To evaluate the effectiveness of a night-time wrist/ hand splint in patients with rheumatoid arthritis. Design: Randomised controlled trial with concealed allocation, outcome assessor blinding, adequate followup, baseline equivalence and intent-to-treat analysis. PEDro score=6/8 internal validity; 2/2 statistical reporting. Setting: Outpatient clinics, Rheumatology Division, University of Sao Paulo, Brazil Participants: Fifty participants with rheumatoid arthritis (average duration 9.5 years), 82% female, average age 51, mean hand pain on entry to study approximately 6 on a 0-10 visual analog scale (VAS). Intervention: A positioning splint was made for participants in the experimental group with instructions to wear it while sleeping. The splint placed hand in 10° wrist dorsiflexion, 25-30° flexion of metacarpophalangeal joints, 30° proximal interphalangeal joint flexion and thumb abduction. Mean time of splint use per night was 8 hours (range 4.5-11 hours). Participants in the control group were not provided with a splint. Outcome measures: Participants assessed at baseline, 45 and 90 days. Primary outcome hand pain (VAS scale 0-10). Secondary outcomes included grip strength (using the Jamar dynamometer); pinch strength (using pinch gauge); function (measured with Health Assessment Questionnaire that has a score range of 0 to 3 with higher scores indicating poorer function); upper limb disability and symptoms (measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire); and patient satisfaction with treatment (Likert scale). Main findings: At 3 months the mean VAS hand pain for the control group was 5.79 (standard deviation (SD) 2.14) versus 3.4 (SD 2.08) in the splint group. This equates to a mean difference between groups in hand pain at 3 months of 2.39, with a 95% confidence interval (CI) of 1.15 to 3.63. Statistically significant differences were also found between groups for Health Assessment Questionnaire score (0.55, 95% CI 0.25 to 0.84), DASH Q2 score (34.72, 95% CI 24.54 to 44.90) and DASH Q3 score (21.07, 95% CI 11.42 to 30.72), and palmer pinch strength (-0.88, 95% CI -1.66 to -0.10). Authors' conclusions: The use of a night-time hand positioning splint reduces pain, improves grip and pinch strength, upper limb function and functional status in patients with rheumatoid arthritis. © 2009 The Authors. Journal compilation

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