protocolSection identificationModule nctId: NCT06316583, orgStudyIdInfo id: BJH-001, briefTitle: Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Hospital, class: OTHER_GOV, collaborators name: Beijing Municipal Health Commission, descriptionModule 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, conditionsModule conditions: Trigger Point Pain, Myofascial, conditions: Acupuncture, conditions: Primary Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: TrP-DN and Acupuncture, outcomesModule primaryOutcomes measure: mean intensity of pain, secondaryOutcomes 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, secondaryOutcomes measure: Short Form Health Survey, secondaryOutcomes measure: Global Rating of Change Scale, secondaryOutcomes measure: the amount of NSAIDs used, secondaryOutcomes measure: the frenquecy of NSAIDs used, secondaryOutcomes measure: inflammatory factors, secondaryOutcomes measure: local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio, secondaryOutcomes measure: local uterine blood flow：Pulsatility Index (PI), secondaryOutcomes measure: local uterine blood flow：The Resistance Index (RI), secondaryOutcomes measure: Number of Participants with adverse effects with treatment, otherOutcomes measure: Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments, otherOutcomes measure: Rate of same points used between dry-needling group and traditional acupuncture group, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yanxia Sun, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Yanxia Sun, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Yanxia Sun, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: LiHua Yang, role: CONTACT, phone: 8616601298893, contacts name: Yi Ren, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False