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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
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.
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.
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.
Harran University Faculty of Medicine Training and Research Hospital
Sanliurfa, Şanlıurfa, Turkey (Türkiye)
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.
Time frame: Baseline and the first menstrual cycle following completion of the 6-week intervention (T1)
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.
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
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.
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
The number of occasions on which analgesic medication was used for menstrual pain was recorded during each assessment cycle.
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
Whether the participant used any analgesic medication for menstrual pain during the assessment cycle was recorded as a dichotomous outcome.
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
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.
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
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.
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)
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.
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:
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.
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
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.
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.
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