Yanxia Sun,1 Lihua Yang,1 Lihong Zhu,1 Shu Zhang,2 Wei Cheng,1 Lei Lin,2 Wei Li,3 Min Li,3 Xueli Zhao,1 Jing Guo,4 Zhen Hua1 

1Department of Anesthesiology and Pain Clinic, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 2Department of Acupuncture and Moxibustion, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 3Department of Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China; 4School of Sociology and Population Studies, Renmin University of China, Beijing, People’s Republic of China

Correspondence: Yanxia Sun, Department of Anesthesiology and Pain Clinic, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, 100730, People’s Republic of China, Email sun00017@gmail.com

Background and Objective: Primary dysmenorrhea carries substantial medical, social, and economic burdens, leading many patients to seek low-risk complementary and alternative therapies, such as acupuncture. Myofascial trigger point dry needling (MTrP-DN) has recently gained attention as a potential treatment, though evidence remains limited and its distinction from acupuncture is debated. Therefore, this study aims to evaluate the therapeutic efficacy of MTrP-DN for primary dysmenorrhea, using traditional acupuncture as an active control and sham needling as a passive control.
Methods and Analysis: This is a randomized, subject-blind, sham-controlled trial. A total of 150 subjects with primary dysmenorrhea will be randomly assigned in a 1:1:1 ratio to the MTrP-DN, acupuncture, or sham group, receiving consecutive 3-week treatments with follow-up for 12 months. The primary outcome is pain intensity, measured by the visual analogue scale (VAS). Secondary outcomes include quality of life, non-steroidal anti-inflammatory drug (NSAID) usage, self-reported improvement using the Global Rate of Change (GROC) scale, serum inflammatory markers, and uterine blood flow assessed by Doppler. Outcomes will be evaluated at baseline, 1st month, 2nd months, and 12thmonths post-treatment during menstruation. Multivariate analysis of variance will be used to analyze the interactions between different groups, different time periods, and the interaction of group and time.
Discussion: This study is the first to compare the efficacy of MTrP-DN with acupuncture in the treatment of primary dysmenorrhea, focusing on their effects on pain intensity, uterine blood flow, and inflammatory markers. Including a sham control group helps address blinding issues and accurately assess MTrP-DN’s effects on pain and quality of life.
Trial Registration Number: Clinicaltrial.gov (NCT06316583).

Keywords: myofascial trigger point, dry needling, primary dysmenorrhea, acupuncture