Manual Acupuncture for Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title: Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial

Status Recruiting

Clinical Trial Summary

Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about serious adverse events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The objective of this trail is to assess the clinical efficacy of acupuncture in the prevention of PD and investigate what factors will affect the efficacy of acupuncture.The results of this trial will significantly add to the current body of evidence on the role of acupuncture for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in the prevention of PD. In additional, results from this trial will identify what factors will affect the efficacy of acupuncture.

Clinical Trial Description

This is a multicenter, single blind, randomized controlled, three-arm, large-scale clinical trial. We will recruit 300 PD women who meet diagnostic criteria for PD established in 2005 from Canada gynaecology and obstetrics association. Exclusion criteria include illiteracy, breast feeding women, pregnancy women, serious systemic disease, mental patient, and acupuncture experience. Eligible women will be randomly assigned to verum acupuncture group, sham acupuncture group and usual care group. Participants in the verum acupuncture group will receive traditional acupuncture treatment and will be treated with ture needles, While Participants in the sham acupuncture group will be treated with sham acupuncture with non-insertive needles at non-acupuncture points. Acupuncture treatment will start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days (a treatment course), totally for 15 sessions and 3 treatment courses. Participants in the usual care group will not receive treatment besides health education as a control group. This trail will be composed of a one-menstrual cycle baseline, three-menstrual cycle treatment (cycle 1 to 3), and three-menstrual cycle follow-up period (cycle 4-6). The primary outcome measure is the change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline. Secondary outcome measures include Visual Analogue Scale (VAS), McGill pain questionnaire (SF-MPQ), Pittsburgh sleep quality index (PSQI), and intake of acute medication. Psychological outcome measures are Beck Depression Rating Scale (BDI), Beck Anxiety Inventory (BAI), NEO Five-Factor Inventory (NEO-FFI), the Doctor-Patient Relationship Scale (PDRQ), the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ), and Expectations for interventions assessed by acupuncture expectancy scale (AES). Deqi sensation will be measured by MGH Acupuncture Sensation Scale (MASS). ;

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

• NCT number: NCT02783534
• Study type: Interventional
• Source: Huazhong University of Science and Technology
• Contact: Shabei Xu, Doctor
• Phone: 86-13554178768
• Email: xushabei@126.com
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2016
• Completion date: July 1, 2021