Abstract
BackgroundPrimary dysmenorrhea (PD) is one of the most common health complaints all over the world, specifically among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females.Methods/designThis study will carry out a randomized parallel controlled single-blind trial to observe the immediate analgesia effect of WAA in PD of young females. Sixty participants who meet inclusion criteria will be recruited from September 2016 to September 2017 in Changhai hospital of China. They are randomly assigned to WAA therapy or sham acupuncture groups (30 patients for each group), and then receive real or sham acupuncture treatment, respectively. In this trial, the primary outcome measure is simple form of McGill pain questionnaire (SF-MPQ), while expectation and treatment credibility scale (ETCS), safety assessment, the COX menstrual symptom scale (CMSS), questionnaire about the feeling of being punctured are included in the secondary outcomes.DiscussionThis trial will be the first study protocol designed to evaluate the immediate analgesia effect of WAA in PD of young females. The strengths in methodology, including rigorous randomized, sham-controlled, participants-blinded and assessors-blinded, will guarantee the quality of this study. WAA doesn’t require any needling sensation, so non-penetrating sham acupuncture can serve as an effective placebo intervention in this trial.Trials registrationChinese Clinical Trial Registry (identifier: ChiCTR-IOR-16008546; registration date: 27 May 2016).
Highlights
Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, among young females
wrist-ankle acupuncture (WAA) doesn’t require any needling sensation, so nonpenetrating sham acupuncture can serve as an effective placebo intervention in this trial
The entire statistical test will use bilateral examination, and the significance level sets at P < 0.05. The result of this trial is expected to provide highquality clinical evidence that WAA is effective for young females with PD
Summary
Primary dysmenorrhea (PD) is one of the most common health complaints all over the world, among young females. Acupuncture has been employed to relieve the pain-based symptoms and to avoid the side effects of conventional medication, and wrist-ankle acupuncture (WAA) has confirmed analgesic efficacy for various types of pain. The aim of this study is to evaluate the immediate analgesia effect of WAA on PD of young females. Dysmenorrhea is a common disease in females of reproductive age [1], leading to the activity limitation, efficiency impairment, and even life quality decrease. NSAIDs and other drugs can alleviate the pain of PD significantly, their application is limited, mostly because of their disability in curing the disease along with their side effects and unaffordable high prices [5, 6].
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