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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.
- Source :
- BMC Complementary & Alternative Medicine; 2/2/2016, p1-9, 9p, 1 Chart
- Publication Year :
- 2016
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- CHRONIC pain treatment
NECK pain treatment
ACADEMIC medical centers
ACUPUNCTURE
ACUPUNCTURE points
ANALYSIS of covariance
BIOMARKERS
CHI-squared test
FISHER exact test
HEART beat
PLACEBOS
PSYCHOMETRICS
QUALITY of life
QI (Chinese philosophy)
RANDOMIZED controlled trials
BLIND experiment
DATA analysis software
DESCRIPTIVE statistics
MANN Whitney U Test
MYOFASCIAL release
Subjects
Details
- Language :
- English
- ISSN :
- 14726882
- Database :
- Complementary Index
- Journal :
- BMC Complementary & Alternative Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 112724662
- Full Text :
- https://doi.org/10.1186/s12906-016-1027-y