nctId: NCT06316583 id: BJH-001 briefTitle: Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-12-31 date: 2024-03-18 date: 2024-04-18 name: Beijing Hospital class: OTHER_GOV name: Beijing Municipal Health Commission briefSummary: 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 conditions: Acupuncture conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: 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. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: TrP-DN and Acupuncture measure: mean intensity of pain measure: 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 measure: Short Form Health Survey measure: Global Rating of Change Scale measure: the amount of NSAIDs used measure: the frenquecy of NSAIDs used measure: inflammatory factors measure: local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio measure: local uterine blood flow：Pulsatility Index (PI) measure: local uterine blood flow：The Resistance Index (RI) measure: Number of Participants with adverse effects with treatment measure: Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments measure: Rate of same points used between dry-needling group and traditional acupuncture group sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Yanxia Sun status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Yanxia Sun role: CONTACT lat: 39.9075 lon: 116.39723 facility: Yanxia Sun status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: LiHua Yang role: CONTACT phone: 8616601298893 name: Yi Ren role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False