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Completed
NCT07817628
Pain Neuroscience Education Added to Exercise for Primary Dysmenorrhea
Conditions: Primary Dysmenorrhea
Sex: Female
Ages: 18 Years – 35 Years
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: Harran University
Location: Harran University Faculty of Medicine Training and Research Hospital Sanliurfa Şanlıurfa
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Pregnancy or lactation
* Menstrual irregularity outside the predefined cycle criteria
* Failure to meet the predefined menstrual pain-severity criterion
Source: ClinicalTrials.gov (NCT07817628). StuddyBuddy aggregates publicly available trial information.