STUDY PROTOCOL article
Front. Med.
Sec. Family Medicine and Primary Care
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1644666
Immediate analgesic effect of acupuncture for acute primary dysmenorrhea: protocol of a randomized controlled trial
Provisionally accepted
Gaoyangzi Huang1
Taipin Guo1*Wenjun Li1
Qifu Li1
Xin Tang1
Siwen Zhao1Shumin Zhang1
Ruqin Yang1Zili Liu1Jun Qian2*- 1Yunnan University of Traditional Chinese Medicine, Kunming, China
- 2Anning City First People's Hospital, Affiliated with Kunming University of Science and Technology,, Kunming, China
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Background: Primary dysmenorrhea (PD) is a common gynecological disorder that significantly affects women's work and personal lives, especially in acute episodes when immediate pain relief is often needed. The objective of this study is to evaluate the immediate analgesic effect of acupuncture for acute PD within 10 minutes. Methods: This is a randomized sham-controlled clinical trial involving 80 participants with acute PD who will be randomized in a 1:1 ratio into the Acupuncture group and the Sham acupuncture group. Each participant will receive 10 minutes acupuncture session. For participants in the Sham acupuncture (SA) group, the Park Sham Acupuncture Device (PSD) and blunt needles will be used to simulate treatment without skin penetration. The visual analog scale (VAS) will be evaluated before treatment and at 0-1, 2, 4, 6, 8, and 10 minutes after treatment. The primary outcome is the effective analgesia rate after 10 minutes of acupuncture. Secondary outcomes include effective analgesia rate at other time points (0-1, 2, 4, 6, and 8 minutes), VAS, blinding assessment, and the treatment effectiveness expectations scale. Adverse events during each treatment period will be collected and recorded. All outcomes will be analyzed on an intention-to-treat. The recruitment for this study is expected to be completed between May 1, 2024, and September 1, 2025. Discussion: The primary need of patients with PD is the immediate relief of pain. This study aims to investigate the immediate analgesic effect of acupuncture on acute PD. The results of this study will provide a rapid and reliable clinical basis for the use of acupuncture in the treatment of PD, potentially offering a non-pharmacological alternative for pain management that could reduce reliance on medications and their associated side effects. Trial registration: Chinese Clinical Trial Registry (ChiCTR2300070826).
Keywords: acute, primary, Dysmenorrhea, Immediate, analgesic, effect, Acupuncture, randomized controlled trial
Received: 10 Jun 2025; Accepted: 22 Aug 2025.
Copyright: © 2025 Huang, Guo, Li, Li, Tang, Zhao, Zhang, Yang, Liu and Qian. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Taipin Guo, Yunnan University of Traditional Chinese Medicine, Kunming, China
Jun Qian, Anning City First People's Hospital, Affiliated with Kunming University of Science and Technology,, Kunming, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.