Pilot and Feasibility Studies (Jul 2017)
A pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy
Abstract
Abstract Background Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group? Methods This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m2) who were recruited 4–14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes. Results Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (−4 to 16); HOOS-Pain 10 points (−2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points (−12 to 19); HOOS-Quality of Life 3 points (−7 to 13); and IHOT-33 7 points (−10 to 25). The within-group (95% confidence intervals) change scores for the control group were HOOS-Symptoms −4 points (−17 to 9); HOOS-Pain −2 points (−18 to 13); HOOS-Activity of Daily Living −7 points (−17 to 4); HOOS-Sport 4 points (−16 to 23); HOOS-Quality of Life −5 points (−18 to 9); and IHOT-33 −4 points (−27 to 19). Suggestions to improve study design included greater supervision of exercises and increased access to physiotherapy appointments. Conclusions Results support the feasibility of a full-scale RCT, and recommendations for an adequately powered and improved study to determine the efficacy of this physiotherapy intervention post-hip arthroscopy to reduce pain and improve function are provided. Trial registration Australian Clinical Trials Registry, ACTRN12614000426684
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