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

Официальное название

Clinical Study of Dry Needling on Myofascial Trigger Points Treatment for Primary Dysmenorrhea and Preliminary Investigation of Its Relevance to Acupoints

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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. I

Первичные конечные точки

• mean intensity of pain [Срок оценки: menstrual cycle before treatment, the month after treatment, the second month after treatment,]

Вторичные конечные точки (10)

• 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 [Срок оценки: menstrual cycle one year after treatment]
• Short Form Health Survey [Срок оценки: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment]
• Global Rating of Change Scale [Срок оценки: menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment]
• the amount of NSAIDs used [Срок оценки: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment]
• the frenquecy of NSAIDs used [Срок оценки: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment]
• inflammatory factors [Срок оценки: 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)]
• local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio [Срок оценки: 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：Pulsatility Index (PI) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: through study completion, an average of 2 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Yanxia Sun — Пекин
• Yanxia Sun — Пекин

Публикации

• Sun Y, Yang L, Zhu L, Zhang S, Cheng W, Lin L, Li W, Li M, Zhao X, Guo J, Hua Z. Efficacy of Myofascial Trigger Point Dry Needling in Treatment of Primary Dysmenorrhea: A Study Protocol for a Three-Arm Randomized Controlled Trial. J Pain Res. 2025 Sep 5;18:4623-4633. doi: 10.2147/JPR.S537971. eCollection 2025. PMID 40933501

Идентификаторы

NCT: NCT06316583 · BJH-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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