PMID- 36062127
OWN - NLM
STAT- MEDLINE
DCOM- 20220908
LR  - 20230123
IS  - 2296-2565 (Electronic)
IS  - 2296-2565 (Linking)
VI  - 10
DP  - 2022
TI  - 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.
PG  - 925232
LID - 10.3389/fpubh.2022.925232 [doi]
LID - 925232
AB  - 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.
CI  - Copyright (c) 2022 Hsu, Ng, Chen, Huang, Lee and Tsai.
FAU - Hsu, Yung-Tang
AU  - Hsu YT
AD  - Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang 
      Gung University College of Medicine, Kaohsiung, Taiwan.
FAU - Ng, Hwee-Yeong
AU  - Ng HY
AD  - Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
FAU - Chen, Yung-Hsiang
AU  - Chen YH
AD  - Graduate Institute of Integrated Medicine, College of Chinese Medicine, Research 
      Center for Chinese Medicine and Acupuncture, China Medical University, Taichung, 
      Taiwan.
AD  - Department of Psychology, College of Medical and Health Science, Asia University, 
      Taichung, Taiwan.
FAU - Huang, Yu-Chuen
AU  - Huang YC
AD  - Graduate Institute of Integrated Medicine, College of Chinese Medicine, Research 
      Center for Chinese Medicine and Acupuncture, China Medical University, Taichung, 
      Taiwan.
AD  - Department of Medical Research, China Medical University Hospital and School of 
      Chinese Medicine, China Medical University, Taichung, Taiwan.
FAU - Lee, Yan-Yuh
AU  - Lee YY
AD  - Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial 
      Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
FAU - Tsai, Ming-Yen
AU  - Tsai MY
AD  - Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang 
      Gung University College of Medicine, Kaohsiung, Taiwan.
AD  - Graduate Institute of Integrated Medicine, College of Chinese Medicine, Research 
      Center for Chinese Medicine and Acupuncture, China Medical University, Taichung, 
      Taiwan.
LA  - eng
SI  - ClinicalTrials.gov/NCT04417101
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220819
PL  - Switzerland
TA  - Front Public Health
JT  - Frontiers in public health
JID - 101616579
SB  - IM
MH  - Cross-Over Studies
MH  - *Fistula
MH  - Humans
MH  - Pain
MH  - *Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Renal Dialysis
PMC - PMC9437307
OTO - NOTNLM
OT  - Chinese herbal medicine
OT  - hemodialysis
OT  - myofascial pain
OT  - randomized trial
OT  - study protocol
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/09/06 06:00
MHDA- 2022/09/09 06:00
PMCR- 2022/08/19
CRDT- 2022/09/05 04:20
PHST- 2022/04/21 00:00 [received]
PHST- 2022/08/04 00:00 [accepted]
PHST- 2022/09/05 04:20 [entrez]
PHST- 2022/09/06 06:00 [pubmed]
PHST- 2022/09/09 06:00 [medline]
PHST- 2022/08/19 00:00 [pmc-release]
AID - 10.3389/fpubh.2022.925232 [doi]
PST - epublish
SO  - Front Public Health. 2022 Aug 19;10:925232. doi: 10.3389/fpubh.2022.925232. 
      eCollection 2022.