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Exercise and Manual Therapy Arthritis Research Trial (EMPART) for osteoarthritis of the hip: a multicentre randomised controlled trial |
French HP, Cusack T, Brennan MA, Caffrey MA, Conroy R, Cuddy MV, Fitzgerald OM, Gilsenan MC, Kane D, O'Connell PG, White MB, McCarthy GM |
Archives of Physical Medicine and Rehabilitation 2013 Feb;94(2):302-314 |
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* |
OBJECTIVE: To determine the effectiveness of exercise therapy (ET) compared to ET with adjunctive manual therapy (ET+MT) for people with hip osteoarthritis (OA). A secondary aim was to identify if immediate commencement of ET or ET+MT was more beneficial than a 9 week waiting period for either intervention. DESIGN: Assessor-blind randomised controlled trial with 9 and 18 week follow-ups. SETTING: Four academic teaching hospitals, Dublin, Ireland. PARTICIPANTS: 131 patients with hip OA recruited from general practitioners, rheumatologists, orthopaedic surgeons, and other hospital consultants were randomised to one of three groups: ET (n = 45), ET+MT (n = 43) and wait-list control (n = 43). INTERVENTIONS: Participants in both ET and ET+MT groups received up to 8 treatments over 8 weeks. Control group participants were re-randomised into either ET or ET+MT group after 9 week follow-up. Their data were pooled with original treatment group data: ET (n = 66) and ET+MT (n = 65). MAIN OUTCOME MEASURES: The primary outcome was the WOMAC physical function (PF) subscale. Secondary outcomes included physical performance, pain, hip range of motion (HROM), anxiety/depression, quality of life, medication usage, patient-perceived change and patient satisfaction. RESULTS: There was no significant difference in WOMAC PF between ET (n = 66) and ET+MT (n = 65) groups at 9 weeks (mean diff 0.09 (95% CI -4.41 to 5.25)) or at 18 weeks (mean diff 0.42 (95% CI -3.98 to 6.83)), or other outcomes, except 'patient satisfaction with outcome' which was higher in the ET+MT group (p = 0.02). Improvements in WOMAC, HROM and patient-perceived change occurred in both treatment groups compared with the control group. CONCLUSION: Self-reported function, HROM and patient-perceived improvement occurred after an 8 week programme of ET for patients with hip OA MT as an adjunct provided no further benefit, except for higher patient satisfaction.
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