title: Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial.
abstract: BACKGROUND
  The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture.
  
  
  METHODS
  A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a ≥3 month history of neck pain and a score of ≥4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA group (n = 37) or sham acupuncture group (n = 37). The participants will receive the MMRA treatment or sham acupuncture treatment twice per week for 4 weeks. The primary outcome is the mean change in the PI-NRS (0 = no pain and 10 = worst possible pain, 11-point Likert scale) from baseline to 4 weeks. The secondary outcomes are the mean change from baseline on the clinical relevance of the pain (ratio of changes greater than 1.5 or with percentiles greater than 30 % and 50 % in the PI-NRS), function (Neck Disability Index and Cervical Range of Motion), autonomic and psychometric measurements (Heart Rate Variability and Perceived Stress Scale), quality of life (EuroQol), global assessment (Patient Global Impression of Change), semi-objective outcomes (pressure pain threshold, consumption of rescue medicine and days of restricted activity) and immunologic/stress biomarkers. Adverse events will be evaluated at every visit.
  
  
  CONCLUSIONS
  The results of this trial will provide evidence to confirm the efficacy and safety of acupuncture for chronic neck pain.
  
  
  BACKGROUND
  The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001573 .
authors.affiliation: Department of Acupuncture & Moxibustion, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. kmdoctorlee@gmail.com.
authors.forename: Seunghoon
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. hanisanam@khu.ac.kr.|Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. hanisanam@khu.ac.kr.
authors.forename: Dongwoo
authors.initials: D
authors.lastname: Nam
authors.affiliation: Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. julcho@naver.com.
authors.forename: Jungtae
authors.initials: J
authors.lastname: Leem
authors.affiliation: Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. kmdhgj@naver.com.
authors.forename: Gajin
authors.initials: G
authors.lastname: Han
authors.affiliation: Department of Acupuncture & Moxibustion, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. seungmin_87@hanmail.net.
authors.forename: Seungmin
authors.initials: S
authors.lastname: Lee
authors.affiliation: Department of Sasang Constitutional Medicine, College of Korean Medicine, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. ssljh@khu.ac.kr.|Korean Medicine Clinical Trial Center, Kyung Hee University Korean Medicine Hospital, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea. ssljh@khu.ac.kr.
authors.forename: Junhee
authors.initials: J
authors.lastname: Lee
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D000368:Aged; D059350:Chronic Pain / Q000628:therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D016740:Meridians; D008875:Middle Aged; D019547:Neck Pain / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D055815:Young Adult
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