Supplementary file 1_Immediate analgesic effect of acupuncture for acute primary dysmenorrhea: protocol of a randomized controlled trial.docx

BackgroundPrimary 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 min.
MethodsThis 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 min 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 min after treatment. The primary outcome is the effective analgesia rate after 10 min of acupuncture. Secondary outcomes include effective analgesia rate at other time points (0–1, 2, 4, 6, and 8 min), 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.
DiscussionThe 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.
Clinical trial registrationIdentifier ChiCTR2300070826. This study has been registered at the Chinese Clinical Trial Registry (https://www.chictr.org.cn).