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Acupuncture for chronic neck pain with sensitive points: study protocol for a multicentre randomised controlled trial
  1. Mingsheng Sun,
  2. Guoyan Geng,
  3. Jiao Chen,
  4. Xingsha Ma,
  5. Mingxi Yan,
  6. Xiaojia Liu,
  7. Jiarong Du,
  8. Dingjun Cai,
  9. Hui Zheng,
  10. Ling Zhao,
  11. Fan-rong Liang
  1. College of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, China
  1. Correspondence to Dr Fan-rong Liang; acuresearch{at}126.com

Abstract

Introduction Chronic neck pain is a challenging condition to treat in clinical practice and has a considerable impact on quality of life and disability. According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state. Stimulation of such sensitive points may lead to disease improvement and improved clinical efficacy. This study aims to evaluate the efficacy and safety of needling at sensitive acupoints in providing pain relief, improvement of cervical vertebral function and quality of life in patients with chronic neck pain.

Methods and analysis This multicentre, randomised controlled, explanatory and parallel clinical trial will include 716 patients with chronic neck pain. Study participants will be randomly assigned in a 1:1:1:1 ratio to four treatment groups: the highly sensitive acupoints group, low/non-sensitive acupoints group, sham acupuncture group and waiting-list control group. The primary outcome will be the change in the visual analogue scale score for neck pain from baseline to 4 weeks. Secondary outcomes will be the Northwick Park Neck Pain Questionnaire and McGill pain questionnaire, 12-item Short-Form health survey, Neck Disability Index, changes in the pressure pain threshold, range of cervical motion, Self-Rating Anxiety Scale, Self-Rating Depression Scale and adverse events before treatment, post-treatment, and at 4, 8, 12, 16 and 20 weeks post-treatment. The intention-to-treat approach will be used in the statistical analysis. Group comparisons will be undertaken using χ2 tests for categorical characteristics, and analysis of variance for continuous variables to analyse whether acupuncture in the highly sensitive acupoints group achieves better treatment outcomes than in each of the other three groups.

Ethics and dissemination Ethical approval of this study has been granted by the local Institutional Review Board (ID: 2017 KL-038). The outcomes of the trial will be disseminated through peer-reviewed publications.

Trial registration number ChiCTR1800016371; Pre-results.

  • acupuncture
  • sensitised points
  • chronic neck pain
  • study protocol
  • pressure pain threshold

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

  • Contributors MS, GG, JC, DC, HZ, LZ and F-rL participated in the design of the trial, creating the data analysis plan and drafting the manuscript. XM, MY, XL and JD collected the information needed for the performance of this trial in each centre. All the authors discussed, read and revised the manuscript, and gave final approval for the publication of this study protocol.

  • Funding This work was financially supported by the National Natural Science Foundation of China (no. 81590951, no. 81722050).

  • Competing interests None declared.

  • Ethics approval The study protocol has been approved by the institutional review board and ethics committee of the First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (permission number: 2017 KL-038) (May 2018).

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

  • Data sharing statement The submitted manuscript is a study protocol which includes no primary data now. Further information unaddressed can be obtained from the corresponding author by the contact methods provided in the manuscript.

  • Patient consent for publication Not required.

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