A multi-centre randomised controlled trial evaluating exercise and manual therapy for osteoarthritis of the hip.
Exercise therapy (ET) is recommended in the management of hip OA, although the limited research to date shows small effects for reduction in pain and improvement of physical function. Manual therapy (MT), which comprises joint mobilisations and other hands-on techniques is commonly used by physiotherapists in Ireland as an adjunct to ET for hip OA but lacks evidence of efficacy. Therefore, this RCT (EMPART- Exercise and Manual Physiotherapy Arthritis Research Trial) was undertaken to primarily determine the clinical effectiveness of physiotherapy-based ET with and without MT for hip OA. A secondary aim was to ascertain the impact of an 8-week waiting period for physiotherapy on outcomes. A total of 131 people with hip OA recruited from four hospitals were initially randomised to one of three groups: ET (n=45), ETIMT (n=43) and wait-list control (n=43). Both intervention groups received treatment for 8 weeks, control group participants remained on the waiting list (8 weeks) and were subsequently randomised into the ET or ETIMT group. Their data were pooled with original treatment group data: ET (n=66) and ETIMT (n=65). All participants were assessed post-treatment (9 weeks) and at 18 weeks. The primary outcome was the WOMAC physical function (PF) subscale and secondary outcomes included physical performance tests, pain severity, hip range of motion (HROM), anxietyldepression, quality of life, pain medication usage, patient-perceived change and patient satisfaction. Ethical approval was obtained at all sites. Data were analysed according to intention-to-treat principles to determine between-group differences for the three groups at baseline and 9 weeks, and the two treatment groups at baseline, 9 and 18 weeks. Results for the primary study aim showed no significant difference in WOMAC PF between ET and ETIMT groups at 9 weeks (mean diff -0.91; 95%CI; -6.28, 4.44) and 18 weeks (mean diff -1.41; 95%CI; -7.12, 4.29) or other outcomes except 'patient satisfaction with outcome', which was greater for ETIMT group (p=0.02). Results for the three groups (secondary aim) showed significant improvement in WOMAC, HROM, pain severity and patient perceived improvement in the ET and ETIMT groups compared to the control group, with no significant difference between the three groups in the remaining outcomes. Qualitative interviews of a small sample of EMPART participants found that despite low patient expectations, results were positive for most patients in terms of predominantly physical outcomes. Questionnaire surveys of the EMPART physiotherapists established they generally viewed participation in EMPART as positive and they would continue to use the ET and MT protocols in clinical practice, with some modifications regarding frequency and duration of the interventions. Results indicate that MT has no further benefit as an adjunct to ET for hip OA, but patients can deteriorate in pain and function measures while waiting for physiotherapy. These findings have implications for clinicians who can use treatment time more efficiently and enhance selfmanagement principles for those with hip OA. It also has implications for those managing waiting lists to develop initiatives to minimise waiting times for those receiving physiotherapy.