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

Beijing Hospital

Status: Enrolling

Conditions: Trigger Point Pain, Myofascial; Acupuncture; Primary Dysmenorrhea

Treatments: Other: TrP-DN and Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06316583

BJH-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

dry-needling trigger points treatment (TrP-DN)

Experimental group

Description:

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

Treatment:

Other: TrP-DN and Acupuncture

acupuncture group

Experimental group

Description:

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

Treatment:

Other: TrP-DN and Acupuncture

placebo control group

Sham Comparator group

Description:

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.

Treatment:

Other: TrP-DN and Acupuncture