J Pain Res. 2025 Sep 5;18:4623-4633. doi: 10.2147/JPR.S537971. eCollection 2025.

ABSTRACT

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, 1^st month, 2^nd months, and 12^thmonths 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).

PMID:40933501 | PMC:PMC12419211 | DOI:10.2147/JPR.S537971