Pain Neuroscience Education Added to Exercise for Primary Dysmenorrhea

NCT07817628 | Completed

• 1 other identifier: PD-PNE-RCT-2025-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary dysmenorrhea; Pain neuroscience education; Exercise; Menstrual pain; Pain catastrophizing; Pelvic floor ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and the first menstrual cycle following completion of the 6-week intervention (T1)

Secondary Outcomes (9)

• 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

• Duration of Menstrual Pain

  Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention

• Analgesic Use Occasions

  Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention

• Any Analgesic Use

  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

  Baseline, first menstrual cycle following completion of the 6-week intervention, and menstrual cycle closest to 3 months post-intervention

Study Arms (2)

Pain Neuroscience Education + Exercise

EXPERIMENTAL

Participants receive pain neuroscience education in addition to the standardized exercise program.

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.

Behavioral: Standardized Exercise Program; Behavioral: Routine Menstrual Health Education

Interventions

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.

Pain Neuroscience Education + Exercise

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.

Pain Neuroscience Education + Exercise; Routine Menstrual Health Education + Exercise

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.

Routine Menstrual Health Education + Exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University Faculty of Medicine Training and Research Hospital

Sanliurfa, Şanlıurfa, 63000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Dysmenorrhea

Condition Hierarchy (Ancestors)

Behavior; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 14, 2026
• Study Start: July 11, 2025
• Primary Completion: June 25, 2026
• Study Completion: July 5, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)