Original articleExercise and Manual Physiotherapy Arthritis Research Trial (EMPART) for Osteoarthritis of the Hip: A Multicenter Randomized Controlled Trial
Section snippets
Design
The Exercise and Manual Physiotherapy Arthritis Research Trial (EMPART) multicenter RCT was conducted in 4 academic teaching hospitals in an urban area in Ireland.
The study was approved by each of the hospital's research committees. An initial 3 group parallel arm trial (allocation ratio 1:1:1) was used, with a modified cross-over design, whereby control group participants were crossed over to 1 of 2 intervention arms after a 9-week period, thereby ensuring sufficient power to test the primary
Participants
One hundred and thirty-one patients were recruited across the 4 sites between May 2008 and February 2010. In the initial 3 group allocation, 43 patients were randomized each to the ET+MT and control groups, and 45 were randomized to the ET group. Figure 1 shows participant flow through the trial. Eight patients (6.1%) withdrew from the trial at 9 weeks: 4 declined continuation, 1 had hip surgery, 1 developed cardiac symptoms, 1 could not be contacted by the researcher, and 1 withdrew for family
Primary research aim
This assessor-blinded multicenter RCT assessed the effectiveness of the addition of MT to an 8-week ET program for the treatment of hip OA. There was no significant difference between the ET and ET+MT groups in the majority of outcomes at 9 or 18 weeks, except patient satisfaction with outcome. Because of the number of outcomes assessed in this study, this significant finding of satisfaction may have occurred by chance. Patients reported higher satisfaction with outcome for the ET+MT group, as
Conclusions
This RCT demonstrated that an 8-week program of ET, with and without adjunctive MT, for people with hip OA, showed similar improvements in self-report function, ROM, and PGA at 9 weeks, which were maintained at 18 weeks. However, the clinical meaningfulness of these changes is questionable. Patient satisfaction was higher for those who received adjunctive MT. These findings highlight the benefit of physiotherapy-based exercise for those with hip OA, but no additive benefit from the use of
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Acknowledgments
We thank the treating physiotherapists in this trial: Claire Gilsenan, MSc, Aisling Brennan, MSc, Vanessa Cuddy, BSc, Breon White, MSc, Martina Fitzpatrick, MSc, Aoife Caffrey, MSc, Jennifer Eadie, MSc, Fiona Lenehan, MSc, Rachel Egginton, BSc, Fiachra McLeid, MPhySt, Donal Scanlon, MManTher, Yvette Harte, BSc, Maire-Brid Casey, MManTher, Maura O'Rahilly, BSc, Ruth McCollum, BSc, Mary Cassells, MPhysio, Grainne Quinn, BSc, Fiona Cahill, BSc, Sarah O'Driscoll, MSc, Sheila McDermott, MManTher,
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Supported by a Fellowship for the Therapy Professions from the Health Research Board, Ireland (grant no. CTPF-06-12).
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Clinical Trials Registration No.: NCT007096566