J Orthop Sports Phys Ther. 2015 Dec;45(12):975-83. doi: 10.2519/jospt.2015.6015. Epub 2015 Sep 28.
STUDY DESIGN: A factorial randomized controlled trial. OBJECTIVES: To investigate the addition of manual therapy to exercise therapy for the reduction of pain and increase of physical function in people with knee osteoarthritis (OA), and whether "booster sessions" compared to consecutive sessions may improve outcomes. BACKGROUND: The benefits of providing manual therapy in addition to exercise therapy, or of distributing treatment sessions over time using periodic booster sessions, in people with knee OA are not well established. METHODS: All participants had knee OA and were provided 12 sessions of multimodal exercise therapy supervised by a physical therapist. Participants were randomly allocated to 1 of 4 groups: exercise therapy in consecutive sessions, exercise therapy distributed over a year using booster sessions, exercise therapy plus manual therapy without booster sessions, and exercise therapy plus manual therapy with booster sessions. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score; 0-240 scale) at 1-year follow-up. Secondary outcome measures were the numeric pain-rating scale and physical performance tests. RESULTS: Of 75 participants recruited, 66 (88%) were retained at 1-year follow-up. Factorial analysis of covariance of the main effects showed significant benefit from booster sessions (P = .009) and manual therapy (P = .023) over exercise therapy alone. Group analysis showed that exercise therapy with booster sessions (WOMAC score, -46.0 points; 95% confidence interval [CI]: -80.0, -12.0) and exercise therapy plus manual therapy (WOMAC score, -37.5 points; 95% CI: -69.7, -5.5) had superior effects compared with exercise therapy alone. The combined strategy of exercise therapy plus manual therapy with booster sessions was not superior to exercise therapy alone. CONCLUSION: Distributing 12 sessions of exercise therapy over a year in the form of booster sessions was more effective than providing 12 consecutive exercise therapy sessions. Providing manual therapy in addition to exercise therapy improved treatment effectiveness compared to providing 12 consecutive exercise therapy sessions alone. Trial registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000460808).
研究设计：析因随机对照试验。
目的：探讨在膝关节骨关节炎（OA）患者中，在运动疗法的基础上增加手法治疗以减轻疼痛和提高身体功能的效果，以及与连续治疗相比，“增强治疗”是否能改善治疗效果。
背景：膝关节 OA 患者接受运动疗法联合手法治疗，或通过周期性的增强治疗来分配治疗时间，其获益尚未得到充分证实。
方法：所有参与者均患有膝关节 OA，并接受由物理治疗师监督的 12 次多模式运动疗法。参与者被随机分配到 4 组中的 1 组：连续治疗的运动疗法、分 1 年进行的增强治疗的运动疗法、无增强治疗的运动疗法加手法治疗、以及有增强治疗的运动疗法加手法治疗。主要结局指标是 1 年随访时的西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC 评分；0-240 分）。次要结局指标是数字疼痛评分和体能测试。
结果：在招募的 75 名参与者中，有 66 名（88%）在 1 年随访时保留。主效应的析因分析显示，增强治疗（P=0.009）和手法治疗（P=0.023）明显优于单纯运动疗法。组间分析显示，与单纯运动疗法相比，增强治疗的运动疗法（WOMAC 评分，-46.0 分；95%置信区间 [CI]：-80.0，-12.0）和运动疗法加手法治疗（WOMAC 评分，-37.5 分；95%CI：-69.7，-5.5）具有更好的效果。运动疗法加手法治疗联合增强治疗的联合策略并不优于单纯运动疗法。
结论：将 12 次运动疗法分 1 年以增强治疗的形式进行分配比连续 12 次提供运动疗法更有效。与连续 12 次运动疗法相比，提供运动疗法联合手法治疗可提高治疗效果。该试验在澳大利亚和新西兰临床试验注册中心（ACTRN12612000460808）注册。
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