Article Text

Protocol
Myofascial acupuncture versus routine acupuncture for mechanical neck pain: a protocol for a multicentre randomised controlled trial
  1. Xing-Hua Qiu1,
  2. Xing-Yue Yang1,
  3. Yu-Yu Wang2,
  4. Su-Ling Tian3,
  5. Yan-Bin Yan2,
  6. An-Ping Xu1,
  7. Fei Fu2,
  8. Feng-Yun Wen4,
  9. Yang Yang2,
  10. Yang Zhang5,
  11. Yu-Qin Zhang1,
  12. Zhi-Wen Yang1,
  13. Chang Xu1,
  14. Qian-Hui Sun1,
  15. Xiao-Ling Wu1,
  16. Xing-Ye Dai1,
  17. Na Li1,
  18. Kai Cheng1
  1. 1School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
  2. 2Department of Acupuncture-Moxibustion, Sunsimiao Hospital Affiliated to Beijing University of Chinese Medicine, Tongchuan, Shanxi, China
  3. 3Chengs TCM Acupuncture-Moxibustion Hospital, Beijing, China
  4. 4Department of Acupuncture-Moxibustion, Langfang Hospital of Traditional Chinese Medicine, Langfang, Hebei, China
  5. 5Department of Traditional Chinese Medicine, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China
  1. Correspondence to Dr Kai Cheng; 603079{at}bucm.edu.cn

Abstract

Introduction Mechanical neck pain (MNP) is defined as pain in the area of the neck and/or neck-shoulder provoked by body mechanics and which adversely affects physical, psychological and social function. The treatments for MNP are limited. Previous studies and clinical experience have indicated that myofascial acupuncture might be a better treatment option for MNP, but the efficacy is controversial. Therefore, our aim is to compare the efficacy of myofascial acupuncture and routine acupuncture for MNP.

Methods and analysis The study is a multicentre, prospective randomised clinical trial. Patients will be recruited from four tertiary hospitals in China. A total of 438 participants with MNP will be randomly assigned into two groups, namely the ‘Sancai-Tianbu’ myofascial acupuncture group and the routine acupuncture group, at a ratio of 1:1. Each group will receive the acupuncture treatment twice a week for 21 days, totalling six sessions. The primary outcome will be the Visual Analogue Scale score. The secondary outcomes will be the Neck Disability Index, the cervical range of motion and the MOS 36-Item Short Form Health Survey. The assessments will be performed at baseline (immediately after allocation), pretreatment (5 min before every treatment), post-treatment (within 10 min after every treatment), postcourse (within 1 day after the course), and at 1, 3 and 6 months after the course. All patients will be included in the intent-to-treat analysis. Repeated-measure analysis of covariance will be used to determine the effects of the intervention on the outcome measures.

Ethics and dissemination Ethics approval was obtained from China Aerospace Science & Industry Corporation 731 Hospital, with permission number 2022-0204-01. Written informed consent will be obtained from the enrolled patients. Trial results will be disseminated in peer-reviewed publications.

Trial registration number ChiCTR2200061453.

  • Clinical trials
  • COMPLEMENTARY MEDICINE
  • Spine
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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • X-HQ and X-YY are joint first authors.

  • X-HQ and X-YY contributed equally.

  • Contributors KC, X-YY, S-LT, CX and Z-WY designed the study. X-HQ and X-YY drafted the manuscript. A-PX, Y-QZ and Q-HS will carry out the statistical calculation. X-YD, NL and X-LW revised the manuscript. Y-BY, Y-YW, FF and YY sought funding. YZ finished the ethical approval. Y-BY, Y-YW, FF, YY, YZ and F-YW are conducting research. All authors have read and approved the manuscript.

  • Funding This study was supported by the Chinese medicine research programme of Sun Simiao Research Institute of Beijing University of Chinese Medicine (grant number SSMYJY-1-2021-03). The funders had no role in study design, decision to publish or preparation of the manuscript.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.