Primary Dysmenorrhea
Conditions
Keywords
Primary dysmenorrhea, Pain neuroscience education, Exercise, Menstrual pain, Pain catastrophizing, Pelvic floor ultrasound
Brief 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.
Interventions
BEHAVIORALPain Neuroscience Education
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.
BEHAVIORALStandardized Exercise Program
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.
BEHAVIORALRoutine Menstrual Health Education
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.
Sponsors
Harran University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Menstrual Pain Intensity During the First 48 Hours of Menstruation | 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
| Measure | Time frame | Description |
|---|---|---|
| Activity Interference Due to Menstrual Pain | 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. |
| Duration of Menstrual Pain | 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. |
| Analgesic Use Occasions | 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. |
| Any Analgesic Use | 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. |
| School or Work Absence Due to Menstrual Pain | 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. |
| Pain Catastrophizing Scale Score | 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. |
| Pressure Pain Threshold (PPT) | 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. |
| Pelvic Floor Mobility Assessed by Transperineal Ultrasound Description: | 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. |
| Conditioned Pain Modulation | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed