Dysmenorrhea PrimaryNCT07590232
Acupuncture for Primary Dysmenorrhea
A study testing acupuncture and NSAIDs in people with Dysmenorrhea Primary, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The main aim is to investigate the effects of acupuncture on pain intensity and health-related quality of life in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- acupuncture and NSAIDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Hospital
Erzurum, Erzurum, 25040
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysmenorrhea Primary
- Being tested
- acupuncture, NSAIDs
- Keywords
- acupuncture, pain, quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
classical body acupuncture with needle without electrical stimulation
NSAIDsDrug
NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group (AG) | Experimental | 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. Receives: Other: acupuncture |
| Control Group (CG) | Active comparator | The control group received no acupuncture session but continued NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up. Receives: Drug: NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and, therefore, a worse outcome.
Measured: 3 months
Secondary outcomes (2)
The Functional and Emotional Dysmenorrhea Scale (FEDS)
The Functional and Emotional Dysmenorrhea Scale (FEDS) consists of 14 items, with total scores ranging from 14 to 70. Higher scores indicate greater functional and emotional impairment associated with dysmenorrhea and, therefore, a worse outcome.
Measured: 3 months
Short Form-36 (SF-36)
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36), which comprises eight domains. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life and, therefore, a better outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Apr 2022
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590232
- Sponsor's protocol ID
- TTU-2022-10772
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Acupuncture On Pain And Quality Of Life in Primary Dysmenorrhea: A Randomized-Controlled Study
- ClinicalTrials.gov ID
- NCT07590232
- Acronym / sponsor ID
- TTU-2022-10772
- Conditions
- Dysmenorrhea Primary
- Keywords
- acupuncture, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim is to investigate the effects of acupuncture on pain intensity and health-related quality of life in women with primary dysmenorrhea.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group (AG) | Experimental | Other: acupuncturePatients 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. |
| Control Group (CG) | Active comparator | Drug: NSAIDsThe control group received no acupuncture session but continued NSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureclassical body acupuncture with needle without electrical stimulation | Other | Acupuncture Group (AG) |
| NSAIDsNSAID therapy (400 mg ibuprofen three times daily during menstruation) and routine follow-up | Drug | Control Group (CG) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 3 months
Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and, therefore, a worse outcome.
2 secondary outcomes
The Functional and Emotional Dysmenorrhea Scale (FEDS)
Time frame: 3 months
Short Form-36 (SF-36)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and NSAIDs in people with Dysmenorrhea Primary, run by Ataturk University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.