Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints

NCT06316583 | Recruiting

• 1 other identifier: BJH-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Primary dysmenorrhea refers to menstrual pain not caused by pelvic organic lesions, commonly seen in young women, significantly affecting patients' quality of life. Dry needling therapy targeting myofascial trigger points for primary dysmenorrhea has been preliminarily applied in clinical settings. However, related research is limited with questionable quality, hindering its widespread clinical application. Furthermore, is there a connection between myofascial trigger points in dry needling and acupuncture acupoints in terms of selection and mechanism of action? Could this be a new interpretation of acupuncture theory? These are important questions that have garnered widespread attention. This study employs a randomized patient-blinded controlled design, enrolling primary dysmenorrhea patients aged 18 to 30 years. They are randomly divided into three groups: the trigger point dry needling group, traditional acupuncture treatment group, and trigger point sham needle (placebo) group. Changes in pain levels, quality of life scores, inflammatory factor levels, and local blood flow before and after treatment among the three groups are observed. The aim is to assess the therapeutic effects of dry needling trigger points and acupuncture treatments on primary dysmenorrhea and explore their potential mechanisms of action. By comparing the differences and similarities between dry needling trigger points and acupuncture treatments in terms of acupoint selection, treatment effects, and potential mechanisms of action, this study seeks to preliminarily explore the feasibility of integrating trigger point theory into the meridian 'acupoint' theory, laying the foundation for a modern interpretation of acupuncture

Conditions

Trigger Point Pain, Myofascial; Acupuncture; Primary Dysmenorrhea

Keywords

trigger points, dry-needling, primary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• mean intensity of pain

  Participants are asked to mark their intensity of pain using Visual Analog Scale during period time a 100mm horizontal line, with the ends of the line representing the extreme expressions of pain (no pain to maximum pain).The mean intensity of all days with menstrual pain is used for the analysis

  menstrual cycle before treatment, the month after treatment, the second month after treatment,

Secondary Outcomes (10)

• mean intensity of painscale during period a 100mm horizontal line, with the ends of the line representing the extreme expressions of pain (no pain to maximum pain).The mean intensity of all days with menstrual pain is used for the analysis

  menstrual cycle one year after treatment

• Short Form Health Survey

  menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

• Global Rating of Change Scale

  menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment

• the amount of NSAIDs used

  menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

• the frenquecy of NSAIDs used

  menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

Other Outcomes (2)

• Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments

  before treatment

• Rate of same points used between dry-needling group and traditional acupuncture group

  through study completion, an average of 2 year

Study Arms (3)

dry-needling trigger points treatment (TrP-DN)

EXPERIMENTAL

Firstly, use pressure techniques to diagnose trigger points on the rectus abdominis and oblique muscles, which typically present as distinct tender points and palpable muscle tension bands. Deep pressure on these points may induce referred pain. Procedure: Begin by disinfecting the treatment sites. Use a traditional acupuncture needle (0.35×50mm) to repeatedly stimulate the designated point until muscle soreness and localized twitching are felt. If participants experience lower back pain, trigger points on the back can also be targeted, located bilaterally from the twelfth thoracic vertebra to the third lumbar vertebra

Other: TrP-DN and Acupuncture

acupuncture group

EXPERIMENTAL

Acupuncturists use acupuncture point needling for treating PD, focusing primarily on key acupoints from the Foot Taiyin Spleen Meridian, Conception Vessel, Foot Taiyang Bladder Meridian, Foot Yangming Stomach Meridian, and Foot Shaoyin Kidney Meridian. Commonly selected points include Taichong, Xuehai, Zusanli, Yanglingquan, Guanyuan, Uterus, and Sanyinjiao. After routine disinfection, a #32 fine needle is quickly inserted and retained for 30 minutes per session

Other: TrP-DN and Acupuncture

placebo control group

SHAM COMPARATOR

Subjects undergo the same diagnostic and therapeutic procedures as the TrP-DN group but using a 'sham' needling technique. The sham needling is administered by the same expert as the real needling, with retention time and treatment frequency matching those of the genuine needling group. A retractable sham needle apparatus is used without piercing the skin.

Other: TrP-DN and Acupuncture

Interventions

TrP-DN and Acupuncture OTHER

Treatment is conducted by pain specialists and acupuncturists, each having over 5 years of relevant work experience. The treatment occurs within the three weeks leading up to menstruation, administered once a week for a total of three sessions. Additionally, participants are to engage in abdominal stretching exercises starting from the treatment day. These exercises are to be done 3-5 times daily, with each session lasting approximately 2 minutes, and this regimen is to continue for one month. If participants experience significant pain during menstruation, they may take NSAIDs orally for symptomatic relief.

acupuncture group; dry-needling trigger points treatment (TrP-DN); placebo control group

Eligibility Criteria

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

You may qualify if:

• All participants diagnosed explicitly by a gynecologist as having primary dysmenorrhea without pelvic organic lesions.
• Aged between 18 and 30 years.
• A history of cyclical menstrual pain for more than 2 years.
• Pain greater than 30mm on the Visual Analog Scale (VAS, 0-100mm).
• Participants must sign an informed consent form and be willing to undergo acupuncture treatment and cooperate to complete the relevant procedures of this trial.

You may not qualify if:

• Those suffering from secondary dysmenorrhea or any other reproductive and urinary system diseases, such as endometriosis.
• A history of pregnancy, miscarriage, or planning for pregnancy. Individuals with skin infections on the abdomen and lower back.
• Past use of acupuncture therapy or other needling treatments.
• Those with a history of mental illness and severe diseases of the heart, liver, brain, kidneys, hematopoietic system, etc.
• Within the past 6 months, individuals referred to pain clinics, those who have used pain relievers like morphine or pethidine, or those allergic to NSAIDs. Also, those currently taking or receiving anticoagulant medications.
• Individuals who have had adverse reactions to acupuncture (e.g., fainting).

Sponsors & Collaborators

• Beijing Hospital: lead
• Beijing Municipal Health Commission: collaborator

Study Sites (2)

Yanxia Sun

Beijing, Beijing Municipality, 100730, China

RECRUITING

Yanxia Sun

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Sun Y, Yang L, Zhu L, Zhang S, Cheng W, Lin L, Li W, Li M, Zhao X, Guo J, Hua Z. Efficacy of Myofascial Trigger Point Dry Needling in Treatment of Primary Dysmenorrhea: A Study Protocol for a Three-Arm Randomized Controlled Trial. J Pain Res. 2025 Sep 5;18:4623-4633. doi: 10.2147/JPR.S537971. eCollection 2025.

  PMID: 40933501 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hua Zhen

  Beijing Hospital

  STUDY CHAIR

• Yanxia Sun

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Sun

CONTACT

+8613611389939; sun00017@gmail.com

LiHua Yang

CONTACT

+8616601298893

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This experiment is a single-blind study where randomization occurs centrally through an online data management system after collecting baseline data from participants. A designated research coordinator manages the randomization process and facilitates communication among research personnel. Due to the nature of the intervention, operators are aware of the group assignments, but evaluators, unaware of these assignments, assess and collect baseline, post-treatment, and follow-up data. Since none of the participants have received any prior acupuncture or trigger point dry needling treatments, using a scalable sham needle on the same trigger points ensures blinding by simulating the effects of actual treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Using a single-center randomized controlled patient-blind study design, 150 eligible participants are randomly assigned to three groups: a placebo group (sham trigger point needling), a dry-needling trigger points treatment (TrP-DN)group, and a traditional acupuncture group. Compared to the placebo group, this study assesses the effects of TrP-DN and traditional acupuncture on pain and quality of life for primary dysmenorrhea patients, as well as their long-term outcomes. Additionally, the study observes their impact on inflammatory factors and local uterine blood flow, aiming to explore the mechanisms underlying TrP-DN and traditional acupuncture treatments for PD.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)