评估 Juan Bi Tang 治疗瘘管手臂透析相关肌筋膜疼痛的疗效和安全性：一项随机交叉试验的研究方案。
Assessing the efficacy and safety of Juan Bi Tang for dialysis-related myofascial pain in the fistula arm: Study protocol for a randomized cross-over trial.
机构信息
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
出版信息
Front Public Health. 2022 Aug 19;10:925232. doi: 10.3389/fpubh.2022.925232. eCollection 2022.
BACKGROUND
Dialysis-related myofascial pain in hemodialysis (HD) patients is an important issue that is associated with many other psychosomatic problems. Effective interventions are required to alleviate pain in this group. Chinese herbal medicine (CHM) may be a potential therapeutic treatment for reducing pain. The aim of this study is to evaluate the effects of a classic CHM formula intervention on pain intensity, daily function, quality of life (QOL), and safety in patients receiving HD in a dialysis center within the context of southern Taiwan.
METHODS
This will be a randomized, open label, cross-over trial with two parallel groups in a pre- and post-test study. Forty patients reporting myofascial pain related to the arteriovenous (AV) fistula in the arm during regular HD sessions will be recruited. Participants will receive 4 weeks of treatment with Juan Bi Tang (JBT) and 4 weeks of no treatment in a random order, separated by a washout period of 2 weeks. Treatment doses (3 g JBT) will be consumed thrice daily. The primary outcome measure will be the Kidney Disease Quality of Life 36-Item Short-Form Survey. Secondary outcomes will include the Fugl-Meyer Assessment-arm, Visual Analogue Scale (VAS) of pain, and grip strength. Outcomes will be collected before and after each intervention, for a total of four times per participant. The safety evaluation will focus on adverse events (AEs).
DISCUSSION
This study will be the first to use CHM to treat patients receiving HD with dialysis-related myofascial pain in their fistula arm and to perform a complete assessment of the treatment, including records of QOL, arm function and muscle power, severity of pain, and safety. The results of the study will provide convincing evidence on the use of JBT as an adjuvant treatment for dialysis-related myofascial pain.
TRIAL REGISTRATION
Clinicaltrials.gov registry (NCT04417101) registered 30 May 2020.
背景
血液透析（HD）患者的透析相关肌筋膜疼痛是一个重要问题，与许多其他身心问题有关。需要有效的干预措施来减轻这组患者的疼痛。中草药（CHM）可能是一种潜在的治疗方法，可以减轻疼痛。本研究旨在评估经典 CHM 配方干预对台湾南部透析中心接受 HD 治疗的患者疼痛强度、日常功能、生活质量（QOL）和安全性的影响。
方法
这将是一项在预测试和后测试研究中具有两个平行组的随机、开放标签、交叉试验。将招募 40 名在常规 HD 治疗过程中报告手臂动静脉（AV）瘘管相关肌筋膜疼痛的患者。参与者将随机接受 4 周的 Juan Bi Tang（JBT）治疗和 4 周的无治疗，洗脱期为 2 周。治疗剂量（3 克 JBT）将每日服用三次。主要观察指标将是肾脏病生活质量 36 项简表调查。次要结果将包括 Fugl-Meyer 评估臂、视觉模拟量表（VAS）疼痛和握力。每个干预措施前后将收集四次，共四次。安全性评估将重点关注不良事件（AE）。
讨论
本研究将首次使用 CHM 治疗接受 HD 治疗的患者，治疗其瘘管手臂的透析相关肌筋膜疼痛，并对治疗进行全面评估，包括 QOL、手臂功能和肌肉力量、疼痛严重程度和安全性的记录。该研究的结果将为 JBT 作为透析相关肌筋膜疼痛的辅助治疗提供令人信服的证据。
试验注册
Clinicaltrials.gov 注册（NCT04417101）于 2020 年 5 月 30 日注册。
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