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Efficacy of Thread - Embedding Acupuncture for the Treatment of Primary Dysmenorrhea
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Summary
The goal of this clinical trial is to learn whether thread-embedding acupuncture can help lower menstrual pain in women aged 18 to 29 years with primary dysmenorrhea. Thread-embedding acupuncture is a type of acupuncture in which a small absorbable thread is placed into selected acupuncture points to provide longer-lasting stimulation. The main questions this study aims to answer are: * Does thread-embedding acupuncture combined with standard treatment lower menstrual pain more than standard treatment alone? * Does it improve other menstrual symptoms and lower the need for ibuprofen? What unwanted effects occur during the study? Researchers will compare participants who receive thread-embedding acupuncture plus standard treatment with participants who receive standard treatment alone. Participants will: * Use heat therapy when menstrual pain begins. * Take ibuprofen as rescue medicine when pain is severe, according to the study instructions. * If assigned to the thread-embedding acupuncture group, receive thread-embedding acupuncture before menstruation during two menstrual cycles. * Record menstrual pain, related symptoms, and ibuprofen use during the study. * Be assessed at the start of the study, during two treatment cycles, and during one menstrual cycle after treatment ends.
Official title: The Effectiveness and Safety of Thread-Embedding Acupuncture for the Treatment of Primary Dysmenorrhea: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2024-09-01
Completion Date
2025-04-30
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
Thread-Embedding Acupuncture
Thread-embedding acupuncture is performed using sterile, single-use, preloaded polydioxanone (PDO) absorbable threads. Each device consists of a 30-gauge needle with a 25-mm shaft and a 30-mm PDO thread. Two treatment sessions are given, with one session performed 3 to 7 days before the expected onset of menstruation during each of two consecutive menstrual cycles. Core acupoints are SP6, CV4, CV6, SP10, and EX-CA1. Additional acupoints are selected according to Traditional Chinese Medicine syndrome pattern. Acupoint locations follow World Health Organization standards. The procedure is performed by a licensed physician trained in thread-embedding acupuncture.
Heat Therapy
A warm pack maintained at approximately 40 to 45°C is applied to the lower abdomen when menstrual pain reaches a Visual Analogue Scale score of 4 or higher. Each application lasts approximately 15 to 20 minutes and may be repeated every 2 to 3 hours as needed during menstruation. Participants receive a warm pack and standardized instructions for its use at the beginning of the study.
Ibuprofen 400Mg Tab
Ibuprofen 400 mg is used as rescue medication when menstrual pain reaches a Visual Analogue Scale score of 7 or higher. Participants may continue taking ibuprofen until pain or discomfort improves to a score below 4, for a maximum of 3 days during each menstrual cycle. The total number of 400-mg tablets used during each menstrual cycle is recorded, and adverse events occurring during ibuprofen use are monitored.
Locations (1)
University Medical Center HCMC - Branch 3
Ho Chi Minh City, Vietnam