The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong.
Department of Physical Medicine and Rehabilitation (1986-2015), The University of Kansas, Kansas City, Kansas, USA.
BMJ Open. 2018 Mar 14;8(3):e019103. doi: 10.1136/bmjopen-2017-019103.
Knee 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.
A 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 approval has been obtained (CREC no: 2014.379). Results of the trial will be submitted for publication in a peer-reviewed journal.
ChiCTR-IPC-15006618; Pre-results.
膝骨关节炎（KOA）是一种常见的、使人丧失能力的且代价高昂的医学病症。髌股关节是 KOA 患者疼痛的一个重要来源，髌股关节炎（PFOA）和胫股关节炎（TFOA）同时存在的情况有时也会出现。确定 PFOA 的亚组并采取纠正潜在病理机制的个体化干预措施，对 KOA 患者有益。本研究旨在评估基于诊所的髌骨活动疗法（PMT）是否会显著改善 KOA 患者的疼痛、身体功能和生活质量。
共招募 208 例 PFOA 和 TFOA 共存的患者。将进行一项实用随机临床试验，参与者将被随机分为 PMT 组和候补名单组。对于 PMT 组，将在 2 个月的间隔内进行三次手动松动治疗，并在家中进行股四头肌外侧斜肌锻炼。候补名单组将继续接受他们的常规护理，作为激励，候补名单组将在研究结束后提供 PMT。主要结局指标是西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）疼痛量表，次要结局指标包括 WOMAC 功能和僵硬量表、客观身体功能测试（30 秒椅子站立、40 米快速步行测试、计时起立和行走测试）和欧洲五维健康量表（EQ-5D）评分。所有结局指标将采用意向治疗法在基线和 6 个月时进行评估，并纳入协变量分析。
已获得伦理批准（CREC 编号：2014.379）。试验结果将提交给同行评审期刊发表。
ChiCTR-IPC-15006618；预结果。
