Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK
Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, Greater Manchester, UK.
BMJ Open. 2021 Mar 26;11(3):e048196. doi: 10.1136/bmjopen-2020-048196.
Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients' clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.
A multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.
North West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.
ISRCTN28555470.
膝关节骨关节炎（OA）的支具疗效仍不清楚，国际指南的建议也存在冲突。我们的试验将确定在由物理治疗师提供的一整套建议、书面信息和运动指导中添加膝关节支具（根据患者的临床和影像学表现以及依从性支持进行匹配）的临床和成本效益，这些患者患有膝关节 OA。
这是一项多中心、实用、两平行组、单盲、优效性、随机对照试验，具有内部试点和嵌套定性研究。将从普通诊所、物理治疗转诊和自我转诊中确定的 434 名符合条件的膝关节 OA 症状患者随机分为 1:1 组，分别接受建议、书面信息和运动指导以及膝关节支具治疗，或仅接受建议、书面信息和运动指导。主要分析将是意向治疗，比较主要终点（6 个月）时治疗臂的主要结局（膝关节骨关节炎结局评分（KOOS）-5）（综合膝关节评分），调整预先指定的协变量。KOOS 子量表（疼痛、其他症状、日常生活活动、运动和娱乐功能、膝关节相关生活质量）、自我报告的疼痛、不稳定（弯曲）、治疗反应、身体活动、社会参与、自我效能和治疗可接受性的二次分析将在随机分组后 3、6 和 12 个月进行。协方差分析和逻辑回归将分别对连续和二项式结果进行建模。治疗效果估计将以平均值差异或 OR 与 95%CI 表示。经济评估将估计成本效益。将对参与者和提供干预措施的物理治疗师进行半结构访谈，以探讨试验干预措施的可接受性和经验。
西北普雷斯顿研究伦理委员会、英国健康研究管理局和威尔士健康与护理研究管理局批准了该研究（REC 参考号：19/NW/0183；IRAS 参考号：247370）。该方案是与包括患者和公众在内的利益相关者共同制定的。研究结果将传播给患者和一系列利益相关者。
ISRCTN28555470。
