title: Use of moxibustion to treat primary dysmenorrhea at two interventional times: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Dysmenorrhea is a common menstrual complaint among adolescent girls and women of reproductive age. The treatment of dysmenorrhea is typically selected from multidisciplinary options, including complementary and alternative medicine such as acupuncture and moxibustion. However, there are few published randomized controlled trials concerning moxibustion treatment for dysmenorrhea. This trial aims to investigate the efficacy and safety of moxibustion for primary dysmenorrhea, and to identify the optimal time of moxibustion treatment for primary dysmenorrhea.
  
  
  METHODS
  This protocol is for a randomized controlled trial in which the assessor and statistician will be blinded. A total of 222 eligible patients with dysmenorrhea will be randomly assigned to three groups in a 1:1:1 ratio as treatment group A (treated before menstruation onset), treatment group B (treated at the onset of menstruation), or control group C (waiting list group). The participants assigned to the treatment groups will receive suspended moxibustion treatment at Sanyinjiao (SP6) and Guanyuan (CV4), while the waiting list group will not receive moxibustion treatment until the completion of the study. The trial period will consist of three baseline menstrual cycles, three menstrual cycles of treatment, and three menstrual cycles in the follow-up period. The primary outcome will be measured by changes in the Cox Menstrual Symptom Scale and the secondary outcomes will be measured using the Visual Analogue Scale, Cox Retrospective Symptom Scale, diary entries, the Self-rating Depression Scale, and the Self-rating Anxiety Scale. The safety of moxibustion will be assessed at every visit.
  
  
  CONCLUSIONS
  This trial aims to assess the effectiveness and safety of moxibustion for primary dysmenorrhea, as well as to determine whether the optimal time of treatment for primary dysmenorrhea in clinical practice is before or after the onset of menstrual pain.
  
  
  BACKGROUND
  Chinese Clinical Trial Register: ChiCTR-TRC-14004627 , registered on 9 May 2014.
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. jenny_yang_jie@126.com.
authors: Jie
authors: J
authors: Yang
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. 380895114@qq.com.
authors: Siyi
authors: S
authors: Yu
authors: School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong, China. lxlao1@hku.hk.
authors: Lixing
authors: L
authors: Lao
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. mingxiaoyang@hotmail.com.
authors: Mingxiao
authors: M
authors: Yang
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. abchen@hku.hk.|School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong, China. abchen@hku.hk.
authors: JianPing
authors: J
authors: Chen
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. 16959188@qq.com.
authors: Xiao
authors: X
authors: Luo
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. 825506684@qq.com.
authors: Yongxia
authors: Y
authors: Wang
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. 1143026181@qq.com.
authors: Xiangzhu
authors: X
authors: Chen
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. 785939016@qq.com.
authors: Juan
authors: J
authors: Li
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. zlhcdzy2012@163.com.
authors: Lihua
authors: L
authors: Zhu
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. zhengqianhua@gmail.com.
authors: Qianhua
authors: Q
authors: Zheng
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. hypcdutcm@yeah.net.
authors: Youping
authors: Y
authors: Hu
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. wuxi403@126.com.
authors: Xi
authors: X
authors: Wu
authors: Chengdu University of Traditional Chinese Medicine, NO.37, Shierqiao Road, Jinniu District, Chengdu, Sichuan, 610072, China. acuresearch@126.com.
authors: Fanrong
authors: F
authors: Liang
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000628:therapy*; D005260:Female; D006801:Humans; D009071:Moxibustion; D017063:Outcome Assessment, Health Care; D064232:Visual Analog Scale
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