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Efficacy of a combination of conservative therapies versus an education comparator on clinical outcomes in thumb base osteoarthritis: a randomized clinical trial [with consumer summary] |
Deveza LA, Robbins SR, Duong V, Bennell KL, Vicenzino B, Hodges PW, Wajon A, Jongs R, Riordan EA, Fu K, Oo WM, O'Connell RL, Eyles JP, Hunter DJ |
JAMA Internal Medicine 2021 Apr;181(4):429-438 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
IMPORTANCE: A combination of conservative treatments is commonly used in clinical practice for thumb base osteoarthritis despite limited evidence for this approach. OBJECTIVE: To determine the efficacy of a 6-week combination of conservative treatments compared with an education comparator. DESIGN, SETTING, AND PARTICIPANTS: Randomized, parallel trial with 1:1 allocation ratio among people aged 40 years and older with symptomatic and radiographic thumb base osteoarthritis in a community setting in Australia. INTERVENTIONS: The intervention group (n = 102) received education on self-management and ergonomic principles, a base-of-thumb splint, hand exercises, and diclofenac sodium, 1%, gel. The comparator group (n = 102) received education on self-management and ergonomic principles alone. Intervention use was at participants' discretion from 6 to 12 weeks. MAIN OUTCOMES AND MEASURES: Hand function (Functional Index for Hand Osteoarthritis; 0 to 30) and pain (visual analogue scale; 0 to 100 mm) were measured at week 6 (primary time point) and week 12. An alpha of 0.027 was used at week 6 to account for co-primary outcomes. RESULTS: Of the 204 participants randomized, 195 (96%) and 194 (95%) completed follow-ups at 6 and 12 weeks, respectively; the mean (SD) age of the population was 65.6 (8.1) years, and 155 (76.0%) were female. At week 6, hand function improved significantly more in the intervention group than the comparator (between-group difference, -1.7 units; 97.3% CI -2.9 to -0.5; p = 0.002). This trend was sustained at 12 weeks (-2.4 units; 95% CI -3.5 to -1.3; p < 0.001). Pain scores improved similarly at week 6 (between-group difference, -4.2 mm; 97.3% CI -11.3 to 3.0; p = 0.19). At week 12, pain reduction was significantly greater in the intervention group (-8.6 mm; 95% CI -15.2 to -2.0; p = 0.01). There were 34 nonserious adverse events, all in the intervention group-mostly skin reactions and exercise-related pain exacerbations. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of people with thumb base osteoarthritis, combined treatments provided small to medium and potentially clinically beneficial effects on hand function but not pain. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000353493.
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