Primary DysmenorrheaNCT07817628

Pain Neuroscience Education Added to Exercise for Primary Dysmenorrhea

A study testing Pain Neuroscience Education, Standardized Exercise Program and Routine Menstrual Health Education in people with Primary Dysmenorrhea, run by Harran University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: Pain Neuroscience Education, Standardized Exercise Program and Routine Menstrual Health Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 11 Jul 2025to 5 Jul 2026
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

Women aged 18-35 years
Menstrual cycles of 21-35 days
Symptoms consistent with primary dysmenorrhea for at least 6 months
At least 2 years since menarche
Recurrent menstrual pain during at least 2 menstrual cycles
Menstrual pain intensity of at least 4/10 on the Numerical Rating Scale during menstruation
Willingness to participate
Provision of written informed consent

Who cannot join

Endometriosis, adenomyosis, pelvic inflammatory disease, uterine fibroids, or another gynecological pathology capable of explaining menstrual pain
Use of hormonal contraceptives or other hormonal treatment
Regular analgesic or antidepressant use
Severe orthopedic, neurological, gynecological, chronic, or systemic disease
Any health condition preventing participation in the exercise program
Previous structured pain neuroscience education

Show all 9Show fewer

Pregnancy or lactation
Menstrual irregularity outside the predefined cycle criteria
Failure to meet the predefined menstrual pain-severity criterion

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Harran University Faculty of Medicine Training and Research Hospital
Sanliurfa, Şanlıurfa, 63000

Other trials in Turkey (Türkiye)

About this study

Official title: Pain Neuroscience Education Added to Exercise in Primary Dysmenorrhea: Clinical and Mechanistic Effects in an Assessor-Blinded Randomized Controlled Trial

This assessor-blinded, two-arm randomized controlled trial evaluates the additional effects of pain neuroscience education (PNE) when combined with a standardized exercise program in women with primary dysmenorrhea. Sixty-two participants are randomly allocated in a 1:1 ratio to either PNE plus exercise or time-matched routine menstrual-health education plus the same exercise program. Both groups complete a six-week exercise program performed three times weekly, while education is delivered once weekly for six weeks. Outcomes are assessed at baseline, during the first menstrual cycle after the intervention, and approximately three months after intervention completion. The primary outcome is menstrual pain intensity during the first 48 hours of menstruation. Secondary outcomes include activity interference, analgesic use, pain catastrophizing, pressure pain thresholds, conditioned pain modulation, and dynamic pelvic floor ultrasound measures.

Conditions: Primary Dysmenorrhea
Being tested: Pain Neuroscience Education, Standardized Exercise Program, Routine Menstrual Health Education
Keywords: Primary dysmenorrhea, Pain neuroscience education, Exercise, Menstrual pain, Pain catastrophizing, Pelvic floor ultrasound
Medical subject headings: Motor Activity, Dysmenorrhea

What participants receive

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

Pain Neuroscience EducationBehavioural
Six weekly 35-45-minute structured educational sessions addressing the protective function of pain, uterine nociception, peripheral and central sensitization, pain modulation, neuroplasticity, attention, expectations, stress, sleep, contextual influences, safe movement, and self-management.
Standardized Exercise ProgramBehavioural
A six-week program performed three times weekly for 18 planned sessions, including aerobic activity, lumbopelvic mobility, trunk and hip strengthening, stretching, diaphragmatic breathing, and relaxation/down-training strategies.
Routine Menstrual Health EducationBehavioural
Participants received six weekly 35-45-minute time-matched educational sessions providing routine information about menstruation, menstrual health, lifestyle, and general self-management, without pain neuroscience education content.

Study groups in NCT07817628
Study group	Role	What they receive
Pain Neuroscience Education + Exercise	Experimental	Participants receive pain neuroscience education in addition to the standardized exercise program. Receives: Behavioral: Pain Neuroscience Education; Behavioral: Standardized Exercise Program
Routine Menstrual Health Education + Exercise	Active comparator	Participants receive routine menstrual health education in addition to the same standardized exercise program. Receives: Behavioral: Standardized Exercise Program; Behavioral: Routine Menstrual Health Education

What is being measured

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

Change in Mean Menstrual Pain Intensity During the First 48 Hours of Menstruation
Menstrual pain intensity is recorded using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), three times daily (morning, afternoon, and evening) during menstrual days 1 and 2. The mean of the six ratings is calculated when at least four valid ratings are available. The primary treatment effect compares change from baseline to the first menstrual cycle following completion of the six-week intervention.
Measured: Baseline and the first menstrual cycle following completion of the 6-week intervention (T1)

Secondary outcomes (9)

Activity Interference Due to Menstrual Pain
Interference of menstrual pain with daily activities was assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no interference) to 10 (maximum interference), with higher scores indicating greater interference.
Measured: Baseline, first menstrual cycle following the 6-week intervention (T1), and menstrual cycle closest to 3 months post-intervention
Duration of Menstrual Pain
Interference of menstrual pain with daily activities was assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no interference) to 10 (maximum interference), with higher scores indicating greater interference.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Analgesic Use Occasions
The number of occasions on which analgesic medication was used for menstrual pain was recorded during each assessment cycle.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Any Analgesic Use
Whether the participant used any analgesic medication for menstrual pain during the assessment cycle was recorded as a dichotomous outcome.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
School or Work Absence Due to Menstrual Pain
The number of days of absence from school or work attributable to menstrual pain was recorded during each assessment cycle. Higher values indicate greater absenteeism.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Pain Catastrophizing Scale Score
Pain-related catastrophic thinking was assessed using the Pain Catastrophizing Scale (PCS), a 13-item self-report measure. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing and therefore a worse outcome.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Pressure Pain Threshold (PPT)
Pressure pain threshold was assessed using a Commander Echo Algometer (JTECH Medical, Midvale, UT, USA) equipped with a 1 cm² probe at standardized suprapubic, lumbopelvic, and tibialis anterior sites. Higher values indicate lower mechanical pain sensitivity.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.
Pelvic Floor Mobility Assessed by Transperineal Ultrasound Description:
Pelvic floor mobility was assessed using two-dimensional transperineal ultrasound. Outcomes included cranial excursion during voluntary pelvic floor contraction, caudal excursion during bearing down, and return-to-rest time following the maneuver. Each maneuver was performed three times, and the mean value was used for analysis.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.
Conditioned Pain Modulation
onditioned pain modulation was assessed using tibialis anterior pressure pain threshold as the test stimulus and contralateral hand immersion in cold water (10 ± 1 °C, maximum 120 seconds) as the conditioning stimulus. The CPM response was calculated from the change in pressure pain threshold during conditioning.
Measured: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.

Timeline

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

11 Jul 20255 Jul 2026

First posted14 Sep 2026
Study start11 Jul 2025
Primary completion25 Jun 2026
Study completion5 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary DysmenorrheaStudies 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
Model description: Participants are randomly allocated in a 1:1 ratio to PNE plus exercise or time-matched routine menstrual-health education plus the same exercise program.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07817628
Sponsor's protocol ID: PD-PNE-RCT-2025-01
Status last verified: Sep 2026
First submitted: 1 Sep 2026
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data are not planned to be publicly shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain Neuroscience Education Added to Exercise in Primary Dysmenorrhea: Clinical and Mechanistic Effects in an Assessor-Blinded Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07817628
Acronym / sponsor ID: PD-PNE-RCT-2025-01
Conditions: Primary Dysmenorrhea
Keywords: Primary dysmenorrhea, Pain neuroscience education, Exercise, Menstrual pain, Pain catastrophizing, Pelvic floor ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Harran UniversityUniversity, hospital or other
Study start: 11 Jul 2025 (actual)
Primary completion: 25 Jun 2026 (actual)
Study completion: 5 Jul 2026 (actual)
First posted: 14 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants are randomly allocated in a 1:1 ratio to PNE plus exercise or time-matched routine menstrual-health education plus the same exercise program.

Arm	Type	Receives
Pain Neuroscience Education + Exercise	Experimental	Behavioral: Pain Neuroscience Education, Behavioral: Standardized Exercise ProgramParticipants receive pain neuroscience education in addition to the standardized exercise program.
Routine Menstrual Health Education + Exercise	Active comparator	Behavioral: Standardized Exercise Program, Behavioral: Routine Menstrual Health EducationParticipants receive routine menstrual health education in addition to the same standardized exercise program.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Women aged 18-35 years
Menstrual cycles of 21-35 days
Symptoms consistent with primary dysmenorrhea for at least 6 months
At least 2 years since menarche
Recurrent menstrual pain during at least 2 menstrual cycles

Key exclusion criteria (9 listed)

Endometriosis, adenomyosis, pelvic inflammatory disease, uterine fibroids, or another gynecological pathology capable of explaining menstrual pain
Use of hormonal contraceptives or other hormonal treatment
Regular analgesic or antidepressant use
Severe orthopedic, neurological, gynecological, chronic, or systemic disease
Any health condition preventing participation in the exercise program

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
Pain Neuroscience EducationSix weekly 35-45-minute structured educational sessions addressing the protective function of pain, uterine nociception, peripheral and central sensitization, pain modulation, neuroplasticity, attention, expectations, stress, sleep, contextual influences, safe movement, and self-management.	Behavioural	Pain Neuroscience Education + Exercise
Standardized Exercise ProgramA six-week program performed three times weekly for 18 planned sessions, including aerobic activity, lumbopelvic mobility, trunk and hip strengthening, stretching, diaphragmatic breathing, and relaxation/down-training strategies.	Behavioural	Pain Neuroscience Education + Exercise, Routine Menstrual Health Education + Exercise
Routine Menstrual Health EducationParticipants received six weekly 35-45-minute time-matched educational sessions providing routine information about menstruation, menstrual health, lifestyle, and general self-management, without pain neuroscience education content.	Behavioural	Routine Menstrual Health Education + Exercise

Primary outcome

Change in Mean Menstrual Pain Intensity During the First 48 Hours of Menstruation
Time frame: Baseline and the first menstrual cycle following completion of the 6-week intervention (T1)
Menstrual pain intensity is recorded using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), three times daily (morning, afternoon, and evening) during menstrual days 1 and 2. The mean of the six ratings is calculated when at least four valid ratings are available. The primary treatment effect compares change from baseline to the first menstrual cycle following completion of the six-week intervention.

9 secondary outcomes

Activity Interference Due to Menstrual Pain
Time frame: Baseline, first menstrual cycle following the 6-week intervention (T1), and menstrual cycle closest to 3 months post-intervention
Duration of Menstrual Pain
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Analgesic Use Occasions
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Any Analgesic Use
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
School or Work Absence Due to Menstrual Pain
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Pain Catastrophizing Scale Score
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention
Pressure Pain Threshold (PPT)
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.
Pelvic Floor Mobility Assessed by Transperineal Ultrasound Description:
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.
Conditioned Pain Modulation
Time frame: Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention; assessments were performed during both painful and pain-free phases of the menstrual cycle.

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 16 Sep 2026.
Individual participant dataSharing planned: No. Individual participant data are not planned to be publicly shared.

Related trials for Primary Dysmenorrhea

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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?

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 8 inclusion and 9 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 16 Sep 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?

Change in Mean Menstrual Pain Intensity During the First 48 Hours of Menstruation (time frame: Baseline and the first menstrual cycle following completion of the 6-week intervention (T1)). 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 NCT07817628.

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 16 Sep 2026.