Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorBeijing Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TrP-DN and Acupuncture
Other interventionTreatment 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: dry-needling trigger points treatment (TrP-DN)Experimental treatment 1 intervention
Group B: acupuncture groupExperimental treatment 1 intervention
Group C: placebo control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
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
Time frame
menstrual cycle before treatment, the month after treatment, the second month after treatment,Secondary outcomes
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)
Time frame
menstrual cycle one year after treatment2
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.)
Time frame
menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatment3
Global Rating of Change Scale
Global Rating of Change Scale(GROC)\[It typically ranges from -5 to +5, with 0 representing no change, -5 indicating a very marked worsening, and +5 indicating a very marked improvement\]
Time frame
menstrual cycle at the month after treatment, the second month after treatment, and one year after treatment4
the amount of NSAIDs used
the total amount of NSAIDs used during period
Time frame
menstrual cycle before treatment, the month after treatment, the second month after treatment, and one year after treatmentOther outcomes
1
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.)
Time frame
before treatment2
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
Time frame
through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Hospital
Lead sponsor
Beijing Municipal Health Commission
Collaborator
Source ClinicalTrials.gov