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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316583
• Other study ID #: BJH-001
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Beijing Hospital
• Contact: Yanxia Sun
• Phone: +8613611389939
• Email: sun00017[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acupuncture
• Dysmenorrhea
• Myofascial Pain Syndromes
• Primary Dysmenorrhea
• Trigger Point Pain, Myofascial

Intervention

Other:
• 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. If participants experience significant pain during menstruation, they may take NSAIDs orally for symptomatic relief.

Locations

Country	Name	City	State
China	Yanxia Sun	Beijing	Beijing
China	Yanxia Sun	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Hospital	Beijing Municipal Health Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessing Participants Expectations of Outcomes of Complementary and Alternative Medicine Treatments	The Acupuncture Expectancy Scale (The scores for each item can be adjusted based on the individual being assessed, and the final score can reflect the individual's overall expectancy and confidence levels regarding acupuncture treatment.)	before treatment
Other	Rate of same points used between dry-needling group and traditional acupuncture group	The same acupuncturist compare the trigger points of the TrP-DN group with the sham needle group to determine if they are indeed acupuncture points, and specify their exact names. Record the acupuncture points used for the participants in the needling group and indicate them	through study completion, an average of 2 year
Primary	mean intensity of pain	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	menstrual cycle before treatment, the month after treatment, the second month after treatment,
Secondary	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	Participants are asked to mark their intensity of pain on Visual Analog Scale (0 no pain and 100mm refer to worst pain)	menstrual cycle one year after treatment
Secondary	Short Form Health Survey	Short Form Health Survey-36 (The minimum score for each question is 0, indicating the worst possible health status or quality of life,The maximum score for each question is 100, indicating the best possible health status or quality of life.)	menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
Secondary	Global Rating of Change Scale	Global Rating of Change Scale(GROC)[It typically ranges from -5 to +5, with 0 representing no change, -5 indicating a very marked worsening, and +5 indicating a very marked improvement]	menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment
Secondary	the amount of NSAIDs used	the total amount of NSAIDs used during period	menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
Secondary	the frenquecy of NSAIDs used	the total times of NSAIDs used during period	menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment
Secondary	inflammatory factors	the study uses ELISA to measure specific inflammatory markers in participants at different time points related to their menstrual cycles before and after treatmen.The inflammatory factors examined are based on previous research results and include prostaglandin F2-a (PGF2-a), C-reactive protein (CRP), interleukin-6 (IL-6), and interleukin-8 (IL-8).	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)
Secondary	local uterine blood flow:Doppler Systolic/Diastolic (S/D) Ratio	Using transabdominal color Doppler ultrasound to measure the blood flow of the uterine artery at the lateral border of the cervix: The S/D ratio provides information about the ratio of systolic (peak) to diastolic (minimum) velocities in the blood vessel. A higher S/D ratio indicates higher vascular resistance, while a lower ratio suggests lower resistance.	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.
Secondary	local uterine blood flow:Pulsatility Index (PI)	Using transabdominal color Doppler ultrasound to measure the blood flow of the uterine artery at the lateral border of the cervix:The PI provides information about the vascular resistance. A higher PI indicates higher resistance to blood flow, which can be seen in conditions such as vasoconstriction or occlusion. Conversely, a lower PI suggests lower resistance, which can be seen in conditions such as vasodilation or increased blood flow.	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.
Secondary	local uterine blood flow:The Resistance Index (RI)	The Resistance Index (RI) is a parameter used in Doppler ultrasound to assess vascular resistance. It is calculated as the difference between the peak systolic velocity (PSV) and the end diastolic velocity (EDV), divided by the peak systolic velocity. The RI provides information about vascular resistance. A higher RI indicates higher vascular resistance, which may occur in conditions such as vasoconstriction or occlusion. Conversely, a lower RI suggests lower resistance, which may occur in conditions such as vasodilation or increased blood flow.	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.
Secondary	Number of Participants with adverse effects with treatment	This includes unexpected reactions or uncomfortable symptoms, with a particular focus on complications related to acupuncture. All adverse events reported by participants will be documented in the Case Report Form (CRF).	through study completion, an average of 2 year