PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 22 March 2023, with the registration ID ChiCTR2300069643.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 22 March 2023, with the registration ID ChiCTR2300069643.
摘要：
背景：骨关节炎（OA）是肌肉骨骼疾病中最常见的关节疾病。非手术治疗是膝关节OA（KOA）的标准治疗方法。建议使用超声治疗来减轻OA的疼痛和功能障碍，但仍缺乏高质量的科学证据证明其在OA治疗中的有效性。因此,我们想分析常规物理治疗与低强度脉冲超声（LIPUS）相结合是否可以提高常规治疗的疗效，从而改善KOA患者的症状。
方法：这项随机对照试验旨在招募200名诊断为KOA的患者，38岁或以上，符合KOA临床诊断标准。患者将以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五次疗程，评估将在基线进行，在最后一次干预当天和干预后1个月。主要结果指标将是西安大略省和麦克马斯特大学的分数。次要结果指标将是数字疼痛评分量表，Lequesne量表，测试的时间和膝盖的活动范围。将对辍学和缺失数据进行意向治疗分析。
背景：本研究获得中国医科大学附属盛京医院伦理委员会批准（2023PS592K）。研究结果将传播给参与者，并提供给同行评审的期刊。
背景：该试验已在中国临床试验注册平台（chictr.org。cn)2023年3月22日，注册ID为ChiCTR2300069643。
方法：这项随机对照试验旨在招募200名诊断为KOA的患者，38岁或以上，符合KOA临床诊断标准。患者将以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五次疗程，评估将在基线进行，在最后一次干预当天和干预后1个月。主要结果指标将是西安大略省和麦克马斯特大学的分数。次要结果指标将是数字疼痛评分量表，Lequesne量表，测试的时间和膝盖的活动范围。将对辍学和缺失数据进行意向治疗分析。
背景：本研究获得中国医科大学附属盛京医院伦理委员会批准（2023PS592K）。研究结果将传播给参与者，并提供给同行评审的期刊。
背景：该试验已在中国临床试验注册平台（chictr.org。cn)2023年3月22日，注册ID为ChiCTR2300069643。
