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Effect of a stabilization exercise program versus standard treatment for thumb carpometacarpal osteoarthritis: a randomized trial [with consumer summary] |
Pisano K, Wolfe T, Lubahn J, Cooney T |
Journal of Hand Therapy 2023 Jul-Sep;36(3):546-559 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
STUDY DESIGN: Randomized, interventional trial with 1 year follow-up. INTRODUCTION: Though recommended, evidence is lacking to support specific exercises to stabilize and strengthen the first carpometacarpal (CMC) joint for cases of osteoarthritis (OA). PURPOSE OF THE STUDY: To determine in a naturalistic setting, whether standard treatment plus a home exercise program (ST plus HEP) is more effective than standard treatment (ST) alone in improving Quick Disabilities of Arm, Shoulder and Hand (qDASH) scores, and secondarily, in other patient-centered (pain, function) and clinical outcomes (range of motion, strength). METHODS: A total of 190 patients from a hand therapy practice in northwestern PA were enrolled by informed consent and randomized into ST or ST plus HEP groups. Average age was 60 years, most were female (78%) with sedentary occupations most common (36%). ST group received orthotic interventions, modalities, joint protection education and adaptive equipment recommendations, while the ST plus HEP group received a home exercise program in addition to ST for 6 to 12 months. Follow-up occurred at 3, 6, and 12 months. Outcomes included grip strength, pinch strength, range of motion (ROM), qDASH, Patient Specific Functional Scale (PSFS) and pain ratings. At the 6 month mark, all subjects could change groups if desired. Efficacy data analysis included both parametric and non-parametric tests. The threshold for statistical significance was 0.05 and adjusted for multiple comparisons. RESULTS: Repeated measures ANOVA failed to show a statistically significant difference in strength and ROM assessments between treatment groups over the 12 month follow-up (p >= 0.398). Differences between groups did not exceed 13%. Both the ST and ST plus HEP groups evidenced improvement over time in most patient-focused assessments (p <= 0.011), including improvements exceeding reported clinically important differences in pain with activity and PSFS scores. Scores for these measures were similar at each follow-up period (p >= 0.080) in each group. The presence of CTS exerted no effect on outcomes; longer treatment time was weakly related to poorer qDASH and PSFS scores initially. Of those enrolled, 48% of subjects completed the study. CONCLUSIONS: The addition of a high-frequency home exercise program did not improve clinical or patient-centered outcomes more so than standard care in our sample however, study limitations are numerous. Both groups had decreased pain with activity and improved PSFS scores, meeting the established minimally clinically important difference (MCID) of each at 6 and 12 months. Adherence with the home program was poor and/or unknown.
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