- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07590232
Acupuncture for Primary Dysmenorrhea
May 11, 2026 updated by: Yasemin Cayir, Ataturk University
The Effect Of Acupuncture On Pain And Quality Of Life in Primary Dysmenorrhea: A Randomized-Controlled Study
The main aim is to investigate the effects of acupuncture on pain intensity and health-related quality of life in women with primary dysmenorrhea.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this randomized controlled clinical trial, 64 women with primary dysmenorrhea were randomly assigned to an acupuncture group (AG; n = 30) or a control group (CG; n = 34).
The AG received manual body acupuncture every other day for three menstrual cycles (five sessions per cycle, total of 15 sessions), starting 3-4 days before menstruation in each cycle.
The CG received routine recommendations without additional intervention.
Pain intensity, functional and emotional impact, and quality of life were assessed using the Visual Analog Scale (VAS), Functional and Emotional Dysmenorrhea Scale (FEDS), and the Short Form-36 (SF-36).
Measurements were performed at baseline and on days 30, 60, and 90.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey (Türkiye), 25040
- Ataturk University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- to be women aged 18-35 years with a confirmed diagnosis of primary dysmenorrhea for at least one year
- regular menstrual cycles (28 ± 7 days)
- a VAS score ≥4 in the previous cycle
Exclusion Criteria:
- secondary dysmenorrhea
- currently pregnant, postpartum, or breastfeeding
- used oral contraceptives or intrauterine devices in the last 3 months,
- received acupuncture in the past 6 months, had open wounds at acupuncture points
- presented with severe psychiatric disorder or cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupuncture Group (AG)
Patients in the AG received classical body acupuncture.
The acupuncture points used were: LI-4, LIV-3, KID-3, SP-6, SP-8, HT-7, LU-9, P-6, BL-57, ST-25,28,29,30,36, GV-20, CV-2,3,4,5,6.
|
classical body acupuncture with needle without electrical stimulation
|
|
Active Comparator: Control Group (CG)
The control group received no acupuncture session but continued NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up.
|
NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: 3 months
|
VAS measures pain severity
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Functional and Emotional Dysmenorrhea Scale (FEDS)
Time Frame: 3 months
|
FEDS evaluates the multidimensional impact of dysmenorrhea on participants' daily functioning and emotional well-being
|
3 months
|
|
Short Form-36 (SF-36)
Time Frame: 3 months
|
SF-36 measures quality of life.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
May 11, 2026
First Submitted That Met QC Criteria
May 11, 2026
First Posted (Actual)
May 15, 2026
Study Record Updates
Last Update Posted (Actual)
May 15, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Therapeutics
- Pharmacologic Actions
- Chemical Actions and Uses
- Therapeutic Uses
- Complementary Therapies
- Anti-Inflammatory Agents, Non-Steroidal
- Acupuncture Therapy
Other Study ID Numbers
- TTU-2022-10772
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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