NCT07196150

Brief Summary

The goal of this clinical trial is to find out whether exercise, motor imagery training, and pain neuroscience education can help reduce menstrual pain and improve well-being in young women with primary dysmenorrhea. The study will also look at how these approaches affect menstrual symptoms, movement control, and cognitive flexibility. The main questions it aims to answer are:

  • Does adding motor imagery or pain neuroscience education to an exercise program reduce pain and menstrual symptoms more than exercise alone?
  • Do these approaches improve movement control, thinking flexibility, and knowledge about pain? Researchers will compare three groups:
  • Exercise only
  • Exercise plus motor imagery training
  • Exercise plus pain neuroscience education Participants will:
  • Attend supervised exercise sessions twice a week for 8 weeks
  • Practice either motor imagery or receive short pain neuroscience education, depending on their group
  • Complete questionnaires and tests before and after the program, during the first three days of menstruation

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2025Sep 2026

Study Start

First participant enrolled

February 25, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

September 19, 2025

Last Update Submit

September 19, 2025

Conditions

Keywords

Primary dysmenorrheaMenstrual painExerciseMotor imageryPain educationCognition

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    Pain intensity will be assessed using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain). Participants will be asked to report their average menstrual pain during the first three days of menstruation.

    Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up

  • Pressure Pain Threshold (PPT)

    Pressure pain threshold will be measured using a digital algometer (Baseline dolorimeter) applied to the abdominal region and standardized body sites. The minimum pressure (kg/cm²) at which pain is first perceived will be recorded.

    Baseline and after 8 weeks of intervention (first three days of menstruation)

  • Menstrual Symptom Severity

    Menstrual symptoms (e.g., cramps, headache, back pain, fatigue, mood changes) will be evaluated using the Menstrual Symptom Questionnaire (MSQ). Total and subscale scores will be calculated.

    Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up

Secondary Outcomes (7)

  • Lumbopelvic Motor Control

    Baseline and after 8 weeks of intervention

  • Movement Imagery Ability

    Baseline

  • Central Sensitization

    Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up

  • Cognitive Flexibility

    Baseline and after 8 weeks of intervention

  • Pain Catastrophizing

    Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up

  • +2 more secondary outcomes

Study Arms (3)

Exercise Only

EXPERIMENTAL

Participants will complete an 8-week supervised exercise program including lumbopelvic stabilization, stretching, and endurance training, delivered twice per week.

Behavioral: Exercise Program

Exercise + Motor Imagery

EXPERIMENTAL

Participants will complete the same 8-week supervised exercise program. In addition, they will practice kinesthetic motor imagery of the exercises before performing them.

Behavioral: Exercise ProgramBehavioral: Exercise plus Motor Imagery Training

Exercise + Pain Neuroscience Education

EXPERIMENTAL

Participants will complete the same 8-week supervised exercise program. In addition, they will receive weekly face-to-face pain neuroscience education sessions supported by home assignments.

Behavioral: Exercise ProgramBehavioral: Exercise plus Pain Neuroscience Education

Interventions

Participants will complete an 8-week supervised exercise program, delivered twice per week. The program includes lumbopelvic stabilization, stretching, and endurance training exercises designed to reduce menstrual pain and improve physical function.

Exercise + Motor ImageryExercise + Pain Neuroscience EducationExercise Only

Participants will complete the same 8-week supervised exercise program as the Exercise Only group. In addition, they will practice kinesthetic motor imagery of the prescribed movements prior to performing them, aiming to enhance motor control and pain modulation.

Exercise + Motor Imagery

Participants will complete the same 8-week supervised exercise program as the Exercise Only group. In addition, they will receive weekly face-to-face pain neuroscience education sessions focused on pain neurophysiology, supported with home assignments to reinforce learning.

Exercise + Pain Neuroscience Education

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as female and have biological capacity for menstruation (i.e., women of reproductive age with regular menstrual cycles) are eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female, aged 18-25 years
  • Gynecological examination and ultrasound confirming absence of pelvic pathology
  • History of primary dysmenorrhea for at least 6 months, with pain intensity ≥4 on the Numeric Rating Scale (0-10) during the first 3 days of menstruation
  • Regular menstrual cycles (21-35 days)
  • Nulliparous (no history of pregnancy or childbirth)
  • No systemic, metabolic, rheumatologic, or lumbar pathology
  • Willingness to participate in the 8-week intervention program and attend follow-up assessments

You may not qualify if:

  • Diagnosis of secondary dysmenorrhea (e.g., endometriosis, pelvic inflammatory disease, uterine fibroids, ovarian cysts)
  • Current pregnancy or planning to become pregnant during the study period
  • History of pelvic or abdominal surgery
  • History of sexually transmitted diseases
  • Current use of antidepressants, anxiolytics, or hormonal therapy (e.g., oral contraceptives, intrauterine device)
  • Known neurological, psychiatric, or systemic musculoskeletal disorders
  • Cognitive impairment or attention deficit that may interfere with participation
  • Participation in regular exercise in the last 6 months
  • Use of alternative therapies for dysmenorrhea (e.g., acupuncture, massage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PMID: 27351541BACKGROUND
  • Evans S, Dowding C, Olive L, Payne LA, Druitt M, Seidman LC, Skvarc D, Mikocka-Walus A. Pain catastrophizing, but not mental health or social support, is associated with menstrual pain severity in women with dysmenorrhea: A cross-sectional survey. Psychol Health Med. 2022 Jul;27(6):1410-1420. doi: 10.1080/13548506.2021.1948581. Epub 2021 Jun 30.

    PMID: 34190659BACKGROUND
  • Cuenca-Martinez F, Nieves-Gomez A, Millan-Isasi N, Fuentes-Aparicio L, Sempere-Rubio N. Effects of motor imagery and action observation on pelvic floor and related structures in healthy women: A randomized controlled trial. Hum Mov Sci. 2025 Feb;99:103313. doi: 10.1016/j.humov.2024.103313. Epub 2024 Dec 2.

    PMID: 39626586BACKGROUND
  • Kluska J, Malinowska E, Kowalski J. A pilot longitudinal study of decrease in cognitive functions during the most painful day of the period among women with primary dysmenorrhea. Arch Gynecol Obstet. 2025 Feb;311(2):341-346. doi: 10.1007/s00404-024-07617-9. Epub 2024 Jul 4.

    PMID: 38963585BACKGROUND
  • Carroquino-Garcia P, Jimenez-Rejano JJ, Medrano-Sanchez E, de la Casa-Almeida M, Diaz-Mohedo E, Suarez-Serrano C. Therapeutic Exercise in the Treatment of Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1371-1380. doi: 10.1093/ptj/pzz101.

    PMID: 31665789BACKGROUND

MeSH Terms

Conditions

DysmenorrheaMotor Activity

Interventions

Resistance TrainingExercise

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Muge Dereli PhD Candidate in Physiotherapy and Rehabilitation, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate in Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

September 19, 2025

First Posted

September 29, 2025

Study Start

February 25, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (pain intensity scores, pressure pain threshold values, questionnaire results, and demographic data) will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available beginning 6 months after study completion and will remain available for 5 years.
Access Criteria
Researchers who provide a methodologically sound proposal will be able to access the data for academic purposes. Data will be shared via email request to the principal investigator, subject to approval by the study team.

Locations