A multi-arm cluster randomized clinical trial of the use of knee kinesiography in the management of osteoarthritis patients in a primary care setting

<b>Objective</b>: An important clinical gap reported by primary care physicians (PCPs) in managing knee osteoarthritis patients is the lack of validated tools to help them guide conservative treatment decision-making. This study aimed at evaluating the clinical utility of adding to current medical management (CMM) by PCPs, a dynamic knee kinesiography (KneeKG) exam assessing biomechanical risk factors linked to osteoarthritis progression. <b>Design</b>: In this 6-month cluster randomized controlled trial, primary care clinics were randomized into three groups: 1-CMM by PCPs, 2-CMM+KneeKG, and 3-CMM+KneeKG+Education (a self-management education session and two follow-up group meetings). Primary outcomes were scores on the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales and overall score. <b>Results</b>: Of the 894 patients referred from 87 clinics, 515 participated, 449 (87.2%) completed the study. At 6-month follow-up, patients in both KneeKG groups reported statistically significant improvement on the KOOS overall score (Group2: +5.5; Group3: +5.0), and on the symptoms, pain, and activities of daily living subscales compared to control group (all p <b>Conclusions</b>: Results demonstrated significant improvements in terms of pain, function, and satisfaction in KneeKG groups relative to the CMM. Adding education and supervision further improves clinical outcomes. These findings may support the added value of a KneeKG exam in assisting PCPs in the management of knee osteoarthritis patients.

**研究目标**：初级保健医师（Primary Care Physicians, PCPs）在膝骨关节炎患者管理工作中面临的一项关键临床缺口，是缺乏经过验证的工具以指导保守治疗决策制定。本研究旨在评估在初级保健医师的当前医疗管理（Current Medical Management, CMM）基础上，增加一项用于评估与骨关节炎进展相关的生物力学危险因素的动态膝关节运动成像（Knee Kinesiography, KneeKG）检查的临床应用价值。
**研究设计**：本研究为一项为期6个月的整群随机对照试验，将初级保健诊所随机分为3组：1. 单纯CMM干预组（由初级保健医师实施当前医疗管理）；2. CMM+KneeKG干预组；3. CMM+KneeKG+教育督导组（包含1次自我管理教育课程与2次随访小组会议）。
主要结局指标为膝关节损伤与骨关节炎结局评分（Knee Injury and Osteoarthritis Outcome Score, KOOS）的子量表评分及总评分。
**研究结果**：从87家诊所转诊的894例患者中，共计515例入组，其中449例（87.2%）完成了本研究。在6个月随访时，相较于对照组，两个KneeKG组患者的KOOS总评分（第2组：+5.5；第3组：+5.0）以及症状、疼痛与日常生活活动能力子量表评分均出现具有统计学意义的改善（所有p <）。
**研究结论**：研究结果显示，相较于单纯CMM干预组，KneeKG组患者在疼痛、功能与满意度维度均获得显著改善。辅以教育与随访督导可进一步优化临床结局。上述研究结果可为KneeKG检查辅助初级保健医师管理膝骨关节炎患者提供价值支撑。