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NCT Number: NCT07817628

Pain Neuroscience Education Added to Exercise for Primary Dysmenorrhea

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.

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Key information

Conditions

Primary Dysmenorrhea Behavior Dysmenorrhea Menstruation Disturbances Motor Activity Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harran University Faculty of Medicine Training and Research Hospital

Sanliurfa, Şanlıurfa, 63000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain neuroscience education

Behavioral

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 program

Behavioral

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 Education

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    The number of occasions on which analgesic medication was used for menstrual pain was recorded during each assessment cycle.

  4. 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

    Whether the participant used any analgesic medication for menstrual pain during the assessment cycle was recorded as a dichotomous outcome.

  5. 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

    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.

  6. 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

    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.

  7. 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.

    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.

  8. 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.

    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.

  9. 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.

    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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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