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

Yung-Tang Hsu; Hwee-Yeong Ng; Yung-Hsiang Chen; Yu-Chuen Huang; Yan-Yuh Lee; Ming-Yen Tsai

doi:10.3389/fpubh.2022.925232

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

Front Public Health. 2022 Aug 19:10:925232. doi: 10.3389/fpubh.2022.925232. eCollection 2022.

Authors

Yung-Tang Hsu¹, Hwee-Yeong Ng², Yung-Hsiang Chen^{3

4}, Yu-Chuen Huang^{3

5}, Yan-Yuh Lee⁶, Ming-Yen Tsai^{1

3}

Affiliations

¹ Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
² Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
³ Graduate Institute of Integrated Medicine, College of Chinese Medicine, Research Center for Chinese Medicine and Acupuncture, China Medical University, Taichung, Taiwan.
⁴ Department of Psychology, College of Medical and Health Science, Asia University, Taichung, Taiwan.
⁵ Department of Medical Research, China Medical University Hospital and School of Chinese Medicine, China Medical University, Taichung, Taiwan.
⁶ Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.

Abstract

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.

Keywords: Chinese herbal medicine; hemodialysis; myofascial pain; randomized trial; study protocol.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cross-Over Studies
Fistula*
Humans
Pain
Quality of Life*
Randomized Controlled Trials as Topic
Renal Dialysis

Associated data

ClinicalTrials.gov/NCT04417101