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BMC Complementary Medicine and Therapies
Published in: BMC Complementary Medicine and Therapies 1/2016

Open Access 01-12-2015 | Study protocol

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

Authors: Seunghoon Lee, Dongwoo Nam, Jungtae Leem, Gajin Han, Seungmin Lee, Junhee Lee

Published in: BMC Complementary Medicine and Therapies | Issue 1/2016

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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/design

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.

Discussion

The results of this trial will provide evidence to confirm the efficacy and safety of acupuncture for chronic neck pain.

Trial registration

The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001573. 
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Metadata
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
Authors
Seunghoon Lee
Dongwoo Nam
Jungtae Leem
Gajin Han
Seungmin Lee
Junhee Lee
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2016
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-016-1027-y

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