Clinical trial NCT06316583: Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints
Official title: Clinical Study of Dry Needling on Myofascial Trigger Points Treatment for Primary Dysmenorrhea and Preliminary Investigation of Its Relevance to Acupoints
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Acupuncture
Primary Dysmenorrhea
Keywords: trigger points, dry-needling, primary dysmenorrhea
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Beijing Municipal Health Commission
First posted: 2024-03-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: mean intensity of pain
timeFrame: menstrual cycle before treatment, the month after treatment, the second month after treatment,
Secondary outcomes:
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
timeFrame: menstrual cycle one year after treatment
measure: Short Form Health Survey
timeFrame: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
measure: Global Rating of Change Scale
timeFrame: menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment
measure: the amount of NSAIDs used
timeFrame: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
measure: the frenquecy of NSAIDs used
timeFrame: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
measure: inflammatory factors
timeFrame: 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)
measure: local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio
timeFrame: 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.
measure: local uterine blood flow：Pulsatility Index (PI)
timeFrame: 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.
measure: local uterine blood flow：The Resistance Index (RI)
timeFrame: 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.
measure: Number of Participants with adverse effects with treatment
timeFrame: through study completion, an average of 2 year
Other outcomes:
measure: Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments
timeFrame: before treatment
measure: Rate of same points used between dry-needling group and traditional acupuncture group
timeFrame: through study completion, an average of 2 year
Locations:
city: Beijing
country: China
facility: Yanxia Sun
state: Beijing
city: Beijing
country: China
facility: Yanxia Sun
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Hua Zhen
role: STUDY_CHAIR
affiliation: Beijing Hospital
name: Yanxia Sun
role: PRINCIPAL_INVESTIGATOR
References: