Department of Spine Surgery, The Orthopedics Hospital of Traditional Chinese Medicine Zhuzhou City.
Department of Joint Surgery, Zhuzhou Central Hospital, Zhuzhou, Hunan, China.
Medicine (Baltimore). 2021 Apr 9;100(14):e25431. doi: 10.1097/MD.0000000000025431.
To our knowledge, there have been no published clinical trials to assess the synergistic effects of applying pulsed radiofrequency (PRF) stimulation of the suprascapular nerve (SSN) plus physical therapy on pain and function in patients with adhesive capsulitis. Therefore, we will conduct this present randomized, double-blind study to evaluate the synergistic effects of applying PRF stimulation of the SSN plus physical therapy on pain and function in patients with adhesive capsulitis.
The study protocol is a randomized, controlled, double-blind design. Recruitment will be started in March 2021 and completed in October 2022. The treating surgeon will assess 90 patients for eligibility. The study protocol was approved through Institutional Review Board in the People's Hospital of Beilun district of Ningbo. Each patient will be randomized into 3 treatment groups, receiving PRF stimulation of the SSN or physical therapy or both of them. After baseline examination, all patients will be given a full explanation of the treatment protocol and will be required to sign a written informed consent for study participation and for publication of the results. All the data collectors, surgeons, statistical analysts, as well as result assessors are not aware of grouping assignment. The outcomes include Constant score, visual analog scale score, range of motion, and strength.
This protocol will provide a reliable theoretical basis for the following research.
It is assumed that there will be a remarkable difference in postoperative outcomes between the intervention and control groups.
10.17605/OSF.IO/PZ9ES.
据我们所知，目前还没有发表的临床试验来评估脉冲射频（PRF）刺激肩胛上神经（SSN）联合物理疗法对粘连性肩关节囊炎患者疼痛和功能的协同作用。因此，我们将进行这项随机、双盲研究，以评估 PRF 刺激 SSN 联合物理疗法对粘连性肩关节囊炎患者疼痛和功能的协同作用。
该研究方案为随机、对照、双盲设计。招募工作将于 2021 年 3 月开始，2022 年 10 月完成。治疗外科医生将评估 90 名患者是否符合入选标准。该研究方案已获得宁波市北仑区人民医院伦理委员会的批准。每位患者将随机分为 3 组治疗，分别接受 SSN 的 PRF 刺激、物理治疗或两者联合治疗。基线检查后，所有患者将接受完整的治疗方案解释，并要求签署书面知情同意书，同意参与研究和发表研究结果。所有数据收集者、外科医生、统计分析师和结果评估者均不知道分组情况。结果包括常数评分、视觉模拟评分、活动范围和力量。
本方案将为后续研究提供可靠的理论依据。
假设干预组和对照组在术后结果上会有显著差异。
10.17605/OSF.IO/PZ9ES。
