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Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial
  1. Sook-Hyun Lee1,
  2. Jinho Lee2,
  3. Yoon Jae Lee1,
  4. Me-riong Kim2,
  5. Jae Heung Cho3,
  6. Koh-Woon Kim3,
  7. In-Hyuk Ha1
  1. 1 Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea
  2. 2 Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea
  3. 3 Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea
  1. Correspondence to Dr In-Hyuk Ha; hanihata{at}gmail.com

Abstract

Introduction Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare.

Methods and analysis This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5 weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatment

Ethics and dissemination The project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals.

Trial registration numbers NCT03558178; KCT0003068; Pre-results.

  • chronic neck pain
  • doin therapy
  • cost-effectiveness analysis
  • motion style acupuncture treatment (MSAT)
  • randomized controlled trial (RCT)
  • protocol

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Footnotes

  • Contributors Study concept and design: IHH. Drafting of the manuscript: SHL. Critical revision of the manuscript for important intellectual content: JHL, YJL, M-rK, JHC and K-WK. All authors reviewed the manuscript, approved all the contents and agreed on the submission.

  • Funding This work was supported by a grant from the Traditional Korea Medicine R&D Program through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HB16C0035). The study design, execution, analysis and interpretation of data, and reporting of results will be conducted separately from the funding source.

  • Competing interests None declared.

  • Ethics approval The study protocol was approved by the Institutional Review Board of Jaseng Hospital of Korean Medicine (JASENG 2018-04-005-001, JASENG 2018-05-006, JASENG 2018-05-007, JASENG 2018-05-008), and Kyung Hee University Korean Medicine Hospital at Gangdong (KHNMCOH 2018-03-003-001).

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

  • Author note 2018.04.10 study protocol (original); 2018.05.14 study protocol (amendment 01); 2018.06.08 study protocol (amendment 02); 2018.06.20 study protocol (amendment 03); 2018.08.20 study protocol (amendment 04). We will periodically update to the trial registration site for important protocol modifications and other changes after the publication of this paper.

  • Patient consent for publication Not required.

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