Abstract
BackgroundOsteoarthritis (OA) is the most common joint disease, causing pain and functional impairments. According to international guidelines, exercise therapy has a short-term effect in reducing pain/functional impairments in knee OA and is therefore also generally recommended for hip OA. Because of its high prevalence and clinical implications, OA is associated with considerable (healthcare) costs. However, studies evaluating cost-effectiveness of common exercise therapy in hip OA are lacking. Therefore, this randomised controlled trial is designed to investigate the cost-effectiveness of exercise therapy in conjunction with the general practitioner's (GP) care, compared to GP care alone, for patients with hip OA.Methods/DesignPatients aged ≥ 45 years with OA of the hip, who consulted the GP during the past year for hip complaints and who comply with the American College of Rheumatology criteria, are included. Patients are randomly assigned to either exercise therapy in addition to GP care, or to GP care alone. Exercise therapy consists of (maximally) 12 treatment sessions with a physiotherapist, and home exercises. These are followed by three additional treatment sessions in the 5th, 7th and 9th month after the first treatment session. GP care consists of usual care for hip OA, such as general advice or prescribing pain medication. Primary outcomes are hip pain and hip-related activity limitations (measured with the Hip disability Osteoarthritis Outcome Score [HOOS]), direct costs, and productivity costs (measured with the PROductivity and DISease Questionnaire). These parameters are measured at baseline, at 6 weeks, and at 3, 6, 9 and 12 months follow-up. To detect a 25% clinical difference in the HOOS pain score, with a power of 80% and an alpha 5%, 210 patients are required. Data are analysed according to the intention-to-treat principle. Effectiveness is evaluated using linear regression models with repeated measurements. An incremental cost-effectiveness analysis and an incremental cost-utility analysis will also be performed.DiscussionThe results of this trial will provide insight into the cost-effectiveness of adding exercise therapy to GPs' care in the treatment of OA of the hip. This trial is registered in the Dutch trial registry http://www.trialregister.nl: trial number NTR1462.
Highlights
Osteoarthritis (OA) is the most common joint disease, causing pain and functional impairments
The Osteoarthritis Research Society International (OARSI) [7] reviewed 51 treatment modalities that were investigated in studies published 2006-2009, in which exercise therapy was shown to reduce pain and improve physical functioning in patients with knee OA [8]
Because few hip patients were recruited and no joint-specific data were reported, recommendations for the treatment of hip and/or knee OA are mainly based on knee OA studies; less evidence for the effectiveness of exercise therapy on hip OA symptoms is available
Summary
Osteoarthritis (OA) is the most common joint disease. It is a chronic condition causing pain and disability of especially hip and knee joints [1,2]. The Osteoarthritis Research Society International (OARSI) [7] reviewed 51 treatment modalities that were investigated in studies published 2006-2009, in which exercise therapy was shown to reduce pain and improve physical functioning in patients with knee OA [8]. Because few hip patients were recruited and no joint-specific data were reported, recommendations for the treatment of hip and/or knee OA are mainly based on knee OA studies; less evidence for the effectiveness of exercise therapy on hip OA symptoms is available. This underlines the importance of obtaining more data on the effects of exercise therapy in hip OA. The present research questions are: 1) What is the cost-effectiveness of exercise therapy added to GP care, compared to GP care alone, in patients with OA of the hip? 2) What is the effectiveness of exercise therapy added to GP care, compared to GP care alone, in patients with OA of the hip?
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