Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial.

Methods

Multicentre, parallel group, superiority, statistician blinded, randomised (1:1; block; stratified; centralised web based) controlled trial.

多中心、平行组、优效性、统计学家盲法、随机（1:1; 块状; 分层; 中央化基于网络）对照试验。

Recruitment through general practices and the community in Cheshire, Manchester, North Tyneside, and Staffordshire, England; enrolment 25 November 2019 to 16 September 2022.

通过英格兰切郡、曼彻斯特、北泰恩赛德和斯塔福德郡的全科诊所和社区招募参与者；注册时间为2019年11月25日至2022年9月16日。

466 adults aged ≥45 years with symptoms of knee osteoarthritis.

466名年龄≥45岁，出现膝骨关节炎症状的成年人。

AIE was delivered in one in-person consultation by a trained physiotherapist.

AIE 由一名受过培训的物理治疗师通过一次面对面咨询提供。

Individuals randomised to the AIE+B group were also fitted with a patellofemoral, tibiofemoral unloading, or neutral stabilising knee brace, according to their predominant compartmental distribution of knee osteoarthritis, and were offered a two week follow-up consultation.

被随机分配到 AIE+B 组的个体，根据他们膝骨关节炎的主要间室分布，也被配备了髌股关节、胫股关节卸载或中立稳定型膝关节支具，并提供了为期两周的随访咨询。

Brief motivational interviewing with targeted text reminders supported brace adherence.

简短的动机性访谈辅以针对性的文本提醒支持了护膝的依从性。

The primary outcome was a composite patient reported Knee Osteoarthritis Outcomes Score (KOOS)-5 (0-100) at six months after randomisation.

主要结果是在随机化后六个月，患者报告的膝骨关节炎结果评分（KOOS-5）（0-100）的复合指标。

Key secondary outcomes were KOOS-5 at three and 12 months, KOOS-5 subscale scores, and pain on weight bearing activity at three, six, and 12 months.

关键次要结果包括三个月和12个月时的KOOS-5评分、KOOS-5子量表评分，以及三个月、六个月和12个月时的负重活动疼痛情况。

Results

466 participants (mean age 64 (standard deviation 9) years; 46% female participants) were randomised, with 401 (86%), 394 (85%), and 370 (79%) participants followed up with analysable data at three, six, and 12 months, respectively.

共有466名参与者（平均年龄64（标准差9）岁；女性参与者占46%）被随机分配，分别有401（86%）、394（85%）和370（79%）名参与者在三个月、六个月和12个月时进行了随访，且具有可分析的数据。

At six months, greater improvement in KOOS-5 was seen in the AIE+B group than in the AIE group (adjusted mean difference 3.39, 95% confidence interval(CI) 0.96 to 5.82; effect size 0.24).

六个月时，AIE+B组在KOOS-5评分上的改善大于AIE组（调整后平均差异3.39，95%置信区间（CI）0.96至5.82；效应量0.24）。

Secondary outcomes showed the benefits of AIE+B over AIE that diminished over time.

次要结果表明，AIE+B相对于AIE的优势随时间减少。

The largest effects observed were for pain reduction (KOOS pain (0-100) adjusted mean difference at six months 6.13, 95% CI 3.36 to 8.91; effect size 0.39).

观察到的最大效果是疼痛减轻（六个月时KOOS疼痛评分（0-100）调整后平均差异为6.13，95%置信区间为3.36至8.91；效应量为0.39）。

Adverse events were minor and expected.

不良事件是轻微且可预期的。

Conclusions

Adding compartment specific knee bracing and an adherence intervention to advice, written information, and exercise instruction resulted in small improvements in patient reported outcomes among individuals with knee osteoarthritis.

在给予建议、书面信息和运动指导的基础上，增加特定区域的膝关节支具和依从性干预，对膝骨关节炎患者的自我报告结果产生了轻微的改善。

This safe intervention offers a potential treatment option for this common condition.

这种安全的干预措施为这种常见病症提供了一种潜在的治疗选择。

trial_registration

ISRCTN28555470.

ISRCTN28555470。