Clinical Study of Dry Needling on Myofascial Trigger Points Treatment for Primary Dysmenorrhea and Preliminary Investigation of Its Relevance to Acupoints
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trigger Point Pain, Myofascial
- Sponsor
- Beijing Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- mean intensity of pain
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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
Detailed 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.
Investigators
Yanxia Sun
Principal Investigator
Beijing Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
mean intensity of pain
Time Frame: menstrual cycle before treatment, the month after treatment, the second month after treatment,
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
Secondary Outcomes
- 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)
- the frenquecy of NSAIDs used(menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment)
- inflammatory factors(menstrual cycle before treatment, the same month after treatment, and during the second month after treatment (specifically on the second day of the menstrual cycle as recommended in the study))
- the amount of NSAIDs used(menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment)
- local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio(the same day of the menstrual cycle (specifically recommended on the second day of the menstrual cycle) before treatment, during the same month after treatment, and during the second month after treatment.)
- Number of Participants with adverse effects with treatment(through study completion, an average of 2 year)
- 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)
- local uterine blood flow：Pulsatility Index (PI)(the same day of the menstrual cycle (specifically recommended on the second day of the menstrual cycle) before treatment, during the same month after treatment, and during the second month after treatment.)
- local uterine blood flow：The Resistance Index (RI)(the same day of the menstrual cycle (specifically recommended on the second day of the menstrual cycle) before treatment, during the same month after treatment, and during the second month after treatment.)