Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Department of Pediatrics, College of Korean Medicine, Semyung University, Jecheon, Republic of Korea.
Trials. 2020 Feb 17;21(1):193. doi: 10.1186/s13063-020-4092-y.
Shoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.
METHODS/DESIGN: This study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8-16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer.
The results of this pilot trial will be the bases for a full-scale clinical trial of GBH.
Clinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.
肩部疼痛是指肩部周围肌肉的不适感觉。肌痛的原因是肌肉中乳酸的积累和血液循环受损，在传统的东亚医学中称为血瘀。本研究旨在探讨 Gyejibongnyeong-Hwan（GBH）治疗血瘀相关肩部不适的治疗效果。
方法/设计：本研究将是一项双中心、随机、等待名单对照的初步试验。将招募两所大学医院的肩部疼痛患者，视觉模拟评分（VAS）为 4 分或 4 分以上、血瘀评分 9 分或 9 分以上、甘油三酯水平≥150mg/dl 或总胆固醇水平≥200mg/dl 的患者。共有 40 名参与者将被分配到即时治疗组和等待治疗组。即时治疗组将在入组时接受 8 周的 GBH 治疗，而等待治疗组将在 8 周的对照等待后接受 8-16 周的 GBH 治疗。主要结局是肩部疼痛，次要结局是血瘀评分、血压、踝臂血压指数、臂踝脉搏波速度、体重指数、腰围、血氧指数和血脂、血糖、抵抗素、C 反应蛋白、血清淀粉样蛋白 P 和 D-二聚体水平。
本初步试验的结果将是 GBH 全面临床试验的基础。
临床研究信息服务，KCT0003837。注册于 2019 年 4 月 23 日。https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258。
