Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial

• Published in: BMJ open Vol. 8; no. 3; p. e019103
• Main Authors: Sit, Regina Wing Shan, Chan, Keith Kwok Wai, Yip, Benjamin Hon Kei, Zhang, Daisy Dexing, Reeves, Kenneth Dean, Chan, Ying Ho, Chung, Vincent Chi Ho, Wong, Samuel Yeung Shan
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.03.2018; BMJ Publishing Group
• Subjects: Aged; Arthritis; Clinical trials; Evidence-based medicine; Exercise Therapy - methods; Humans; Intention to Treat Analysis; Knee; Knee Joint; Male; Manipulative therapy; Middle Aged; Osteoarthritis, Knee - therapy; Pain Management - methods; Patellofemoral Joint; Physical Therapy Modalities; Rehabilitation Medicine; Surveys and Questionnaires; Systematic review; Treatment Outcome; United States > US; patellofemoral joint osteoarthritis; randomized clinical trial; study protocol; patella mobilization therapy; knee osteoarthritis
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-019103

IntroductionKnee osteoarthritis (KOA) is a common, disabling and costly medical condition. The patellofemoral joint is a critical source of pain in individuals with KOA, and coexistence of patellofemoral osteoarthritis (PFOA) and tibiofemoral osteoarthritis (TFOA) is sometimes observed. The identification of subgroups with PFOA and customised interventions to correct underlying pathomechanics is beneficial for individuals with KOA. This study aims to evaluate whether a clinic-based patella mobilisation therapy (PMT) leads to significant improvement in pain, physical function and quality of life of individuals with KOA.Methods and analysisA total of 208 participants with coexistence of PFOA and TFOA will be recruited. A pragmatic randomised clinical trial will be conducted, and participants will be randomised into the PMT and waiting list groups. For the PMT group, three manual mobilisation sessions, along with home-based vastus medialis oblique muscle exercise, will be conducted at 2-month intervals. The waiting list group will continue to receive their usual care, and as an incentive the waiting list group will be offered PMT after the study period is over. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and secondary outcomes include the WOMAC function and stiffness subscales, scores for objective physical function tests (the 30 s chair stand, 40-metre fast-paced walk test, the Timed Up and Go Test), and the EuroQol-5D scores. All outcomes will be evaluated at baseline and 6 months using intention-to-treat and incorporating covariate analysis.Ethics and disseminationEthics approval has been obtained (CREC no: 2014.379). Results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberChiCTR-IPC-15006618; Pre-results.