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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Using a single-center, randomized, single-blind study design, 150 eligible subjects were randomly divided into three groups: placebo group (pseudo-acupuncture trigger point group), TrP-DN treatment group, and traditional acupuncture treatment group. Compared with the placebo control group (trigger point sham needle group), the study evaluated the effects of TrP-DN and traditional acupuncture treatment on pain, quality of life, and long-term prognosis of PD patients. The study also observed their effects on inflammatory factors and local uterine blood flow, exploring the possible mechanisms of TrP-DN and traditional acupuncture treatment for PD.

Further observations were made on the differences and similarities between conventional TrP-DN and traditional acupuncture treatment in terms of point selection, treatment effects, and their effects on inflammatory factors and local uterine circulation. The study aimed to explore the relationship between the trigger point theory and the theory of meridians and acupoints, providing a research basis for integrating TrP-DN into traditional acupuncture theory.

Conditions

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Trigger Point Pain, Myofascial Acupuncture Primary Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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dry-needling trigger points treatment (TrP-DN)

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

Group Type EXPERIMENTAL

TrP-DN and Acupuncture

Intervention Type 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

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

Group Type EXPERIMENTAL

TrP-DN and Acupuncture

Intervention Type 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.

placebo control group

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.

Group Type SHAM_COMPARATOR

TrP-DN and Acupuncture

Intervention Type 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.

Interventions

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TrP-DN and Acupuncture

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Those suffering from secondary dysmenorrhea or any other reproductive and urinary system diseases, such as endometriosis.
2. A history of pregnancy, miscarriage, or planning for pregnancy. Individuals with skin infections on the abdomen and lower back.
3. Past use of acupuncture therapy or other needling treatments.
4. Those with a history of mental illness and severe diseases of the heart, liver, brain, kidneys, hematopoietic system, etc.
5. 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.
6. Individuals who have had adverse reactions to acupuncture (e.g., fainting).

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No