Efficacy of Thread - Embedding Acupuncture for the Treatment of Primary Dysmenorrhea

NCT07844174 | Completed

• 2 other identifiers: 3961/QĐ-ĐHYD60.000.000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Dysmenorrhea (PD)

Keywords

Thread embedding acupuncture; Traditional Chinese medicine; Primary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• The change in VAS scores

  Menstrual pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will mark the point that best represents their pain intensity during menstruation. The highest VAS score during the most recent pre-enrollment menstrual cycle will be recorded as baseline (T0). Follow-up VAS scores will be recorded during menstruation in the first intervention cycle (T1), during menstruation in the second intervention cycle (T2), and during menstruation in the first post-intervention menstrual cycle (T3). Lower scores indicate less pain.

  Baseline (T0), first intervention cycle (T1), second intervention cycle (T2), and first post-intervention menstrual cycle (T3), over 3 consecutive menstrual cycles. Each menstrual cycle is defined as 21-35 days, with menstrual bleeding lasting 3-8 days.

Secondary Outcomes (2)

• Change in Traditional Chinese Medicine (TCM) syndrome score

  Baseline (T0), T1, T2, and T3 over 3 consecutive menstrual cycles. Each menstrual cycle is defined as 21-35 days, with menstrual bleeding lasting 3-8 days.

• Adverse events observed during the study

  From the first study intervention through completion of the first post-intervention menstrual cycle (T3), covering 3 consecutive menstrual cycles. Each menstrual cycle is defined as 21-35 days, with menstrual bleeding lasting 3-8 days.

Study Arms (2)

Thread-Embedding Acupuncture + Standard Therapy

EXPERIMENTAL

Participants in this arm receive thread-embedding acupuncture in addition to standard therapy for primary dysmenorrhea. Thread-embedding acupuncture is administered once 3 to 7 days before the expected onset of menstruation during each of two consecutive menstrual cycles. Standard therapy includes heat therapy and rescue ibuprofen according to the study protocol.

Procedure: Thread-Embedding Acupuncture; Other: Heat Therapy; Drug: Ibuprofen 400Mg Tab

Standard Therapy Alone

ACTIVE COMPARATOR

Participants in this arm receive standard therapy for primary dysmenorrhea without thread-embedding acupuncture. Standard therapy includes heat therapy using a warm pack applied to the lower abdomen and rescue ibuprofen 400 mg when menstrual pain is severe, according to the study protocol.

Other: Heat Therapy; Drug: Ibuprofen 400Mg Tab

Interventions

Heat Therapy OTHER

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.

Standard Therapy Alone; Thread-Embedding Acupuncture + Standard Therapy

Ibuprofen 400Mg Tab DRUG

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.

Standard Therapy Alone; Thread-Embedding Acupuncture + Standard Therapy

Thread-Embedding Acupuncture PROCEDURE

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.

Thread-Embedding Acupuncture + Standard Therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 29 years with an active menstrual cycle
• Diagnosis of primary dysmenorrhea according to the American College of Obstetricians and Gynecologists criteria
• Traditional Chinese Medicine diagnosis of either Excess Cold pattern or Qi stagnation and Blood stasis pattern
• Able to understand study procedures and cooperate with the treating physician
• Menstrual pain with a Visual Analogue Scale score of 4 or higher in at least 3 menstrual cycles during the previous 6 months, including the most recent cycle
• Menstrual duration of 3 to 8 days
• Menstrual cycle length of 21 to 35 days
• Willing and able to provide written informed consent

You may not qualify if:

• Suspected or confirmed secondary dysmenorrhea detected by ultrasonography
• History or diagnosis of endometriosis, ovarian cysts, uterine polyps, uterine leiomyomas, adenomyosis, pelvic inflammatory disease, congenital obstructive Mullerian malformations, pelvic adhesions, pelvic masses, or cervical stenosis
• History of needle fainting
• History of hypersensitivity or allergic reaction to catgut, acupuncture, or thread-embedding acupuncture
• Pregnancy or breastfeeding
• Current participation in another clinical trial

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University Medical Center HCMC - Branch 3

Ho Chi Minh City, Vietnam

Location

Related Publications (5)

• Gray SP. Analyzing captial investments. Hosp Purch Manage. 1980 Sep;5(9):3-7. No abstract available.

  PMID: 10309238 BACKGROUND

• McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.

  PMID: 34383437 BACKGROUND

• Yu WY, Ma LX, Zhang Z, Mu JD, Sun TY, Tian Y, Qian X, Zhang YD. Acupuncture for Primary Dysmenorrhea: A Potential Mechanism from an Anti-Inflammatory Perspective. Evid Based Complement Alternat Med. 2021 Dec 3;2021:1907009. doi: 10.1155/2021/1907009. eCollection 2021.

  PMID: 34899943 BACKGROUND

• Kho KA, Shields JK. Diagnosis and Management of Primary Dysmenorrhea. JAMA. 2020 Jan 21;323(3):268-269. doi: 10.1001/jama.2019.16921. No abstract available.

  PMID: 31855238 BACKGROUND

• ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.

  PMID: 30461694 BACKGROUND

MeSH Terms

Interventions

Diathermy; Ibuprofen

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Deputy principal

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blinding: Outcome assessors were not informed of group assignment throughout the study and did not participate in intervention delivery. Assessors recorded outcomes at T0 (baseline), T1 and T2 (intervention cycles), and T3 (post-intervention cycle) and documented results on standardized case report forms. The assessor also prescribed rescue ibuprofen (400 mg) when VAS ≥7.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A randomized, assessor-blind, parallel controlled trial

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 30, 2025
• Last Updated: September 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

VN (1)