Department of Rehabilitation, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China.
Department of Physical Medicine and Rehabilitation, Second Clinical College China Medical University, Shenyang, Liaoning, China.
BMJ Open. 2024 Jul 9;14(7):e082108. doi: 10.1136/bmjopen-2023-082108.
Osteoarthritis (OA) is the most common joint disorder among musculoskeletal conditions. Non-surgical treatment is the standard therapy for knee OA (KOA). Ultrasound therapy is recommended for alleviating pain and dysfunction from OA, but high-quality scientific evidence for its effectiveness in OA treatment is still lacking.Therefore, we want to analyse whether combining conventional physical therapy with low-intensity pulsed ultrasound (LIPUS) can enhance the efficacy of conventional therapy, thus improving symptoms in patients with KOA.
This randomised controlled trial aims to recruit 200 patients diagnosed with KOA, aged 38 years or above, who meet the clinical diagnostic criteria for KOA. Patients will be randomly assigned in a 1:1 ratio to either a LIPUS treatment group or a sham ultrasound treatment control group. The 2-week treatment will consist of five sessions per week and evaluations will take place at baseline, on the day of the last intervention and 1 month post intervention. The main outcome measures will be the Western Ontario and McMaster Universities' scores. Secondary outcome indicators will be the Numerical Pain Rating Scale, the Lequesne scale, the time up and go test and the range of motion of the knee. An intention-to-treat analysis will be performed for dropouts and missing data.
The study was approved by the ethics committee of Shengjing Hospital of China Medical University (2023PS592K). Findings will be disseminated to participants and made available to peer-reviewed journals.
The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 22 March 2023, with the registration ID ChiCTR2300069643.
骨关节炎（OA）是肌肉骨骼疾病中最常见的关节疾病。非手术治疗是膝骨关节炎（KOA）的标准治疗方法。超声治疗被推荐用于缓解 OA 的疼痛和功能障碍，但对于其在 OA 治疗中的有效性的高质量科学证据仍然缺乏。因此，我们想分析常规物理疗法联合低强度脉冲超声（LIPUS）是否能增强常规疗法的疗效，从而改善 KOA 患者的症状。
这项随机对照试验旨在招募 200 名年龄在 38 岁及以上、符合 KOA 临床诊断标准的 KOA 患者。患者将按照 1:1 的比例随机分配到 LIPUS 治疗组或假超声治疗对照组。为期 2 周的治疗将包括每周 5 次，在基线、最后一次干预当天和干预后 1 个月进行评估。主要结局指标将是西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分。次要结局指标将是数字疼痛评分、Lequesne 量表、起立-行走测试和膝关节活动度。对于脱落和缺失数据，将进行意向治疗分析。
该研究得到了中国医科大学盛京医院伦理委员会的批准（2023PS592K）。研究结果将向参与者传播，并在同行评议期刊上发表。
该试验于 2023 年 3 月 22 日在中国临床试验注册平台（chictr.org.cn）注册，注册号为 ChiCTR2300069643。
