AzTrials
AzTrials

Trigger Point Pain, MyofascialNCT06316583

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

A study testing TrP-DN and Acupuncture in people with Trigger Point Pain, Myofascial and Acupuncture, run by Beijing Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 30 years, women only
What is being tested?
TrP-DN and Acupuncture
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
2 sitesChina
Study dates
1 Apr 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

LiHua Yang contact

+8616601298893

China2 sites, 2 recruiting
  • Yanxia Sun

    Beijing, Beijing Municipality, 100730

    Yanxia Sun

    Recruiting
  • Yanxia Sun

    Beijing, Beijing Municipality, 100730

    LiHua Yang, 8616601298893

    Yi Ren

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
TrP-DN and Acupuncture
Keywords
trigger points, dry-needling, primary dysmenorrhea
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrP-DN and AcupunctureOther

    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.

Study groups in NCT06316583
Study groupRoleWhat they receive
dry-needling trigger points treatment (TrP-DN)ExperimentalFirstly, use pressure techniques to diagnose trigger points on the rectus abdominis and oblique muscles, which typically present as distinct tender points and palpable muscle tension bands. Deep pressure on these points may induce referred pain. Procedure: Begin by disinfecting the treatment sites. Use a traditional acupuncture needle (0.35×50mm) to repeatedly stimulate the designated point until muscle soreness and localized twitching are felt. If participants experience lower back pain, trigger points on the back can also be targeted, located bilaterally from the twelfth thoracic vertebra to the third lumbar vertebra
Receives: Other: TrP-DN and Acupuncture
acupuncture groupExperimentalAcupuncturists use acupuncture point needling for treating PD, focusing primarily on key acupoints from the Foot Taiyin Spleen Meridian, Conception Vessel, Foot Taiyang Bladder Meridian, Foot Yangming Stomach Meridian, and Foot Shaoyin Kidney Meridian. Commonly selected points include Taichong, Xuehai, Zusanli, Yanglingquan, Guanyuan, Uterus, and Sanyinjiao. After routine disinfection, a #32 fine needle is quickly inserted and retained for 30 minutes per session
Receives: Other: TrP-DN and Acupuncture
placebo control groupSham comparatorSubjects undergo the same diagnostic and therapeutic procedures as the TrP-DN group but using a 'sham' needling technique. The sham needling is administered by the same expert as the real needling, with retention time and treatment frequency matching those of the genuine needling group. A retractable sham needle apparatus is used without piercing the skin.
Receives: Other: TrP-DN and Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: menstrual cycle before treatment, the month after treatment, the second month after treatment,

Secondary outcomes (10)
  1. 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)

    Measured: menstrual cycle one year after treatment

  2. 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.)

    Measured: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

  3. 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]

    Measured: menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment

  4. the amount of NSAIDs used

    the total amount of NSAIDs used during period

    Measured: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

  5. the frenquecy of NSAIDs used

    the total times of NSAIDs used during period

    Measured: menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment

  6. 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-α (PGF2-α), C-reactive protein (CRP), interleukin-6 (IL-6), and interleukin-8 (IL-8).

    Measured: 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)

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 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.

  9. 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.

    Measured: 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.

  10. 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).

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316583
Sponsor's protocol ID
BJH-001
Status last verified
Mar 2025
First submitted
5 Mar 2024
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data relevant to the study will be included in a published article or uploaded as supplemental information. Our protocol is available on Clinicaltrial.gov and all search strategies will be available in supplemental materials.

Publications

  • 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.

    PubMed 40933501

Questions about this trial

What is this clinical trial studying?

A study testing TrP-DN and Acupuncture in people with Trigger Point Pain, Myofascial and Acupuncture, run by Beijing Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanxia Sun (+8613611389939, sun00017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean intensity of pain (time frame: menstrual cycle before treatment, the month after treatment, the second month after treatment,). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316583, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in