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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 0260 | Other Identifier | İzmir Katip Çelebi University Health Research Ethics Committee |
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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:
Researchers will compare three groups:
Participants will:
Primary dysmenorrhea is a common gynecological condition characterized by menstrual pain without underlying pathology. It negatively impacts quality of life and may affect cognitive functions such as attention and flexibility. Non-pharmacological interventions such as exercise, motor imagery, and pain neuroscience education are promising approaches for pain management without side effects. However, evidence on their effectiveness in primary dysmenorrhea is limited.
This randomized controlled trial is designed to compare the effects of three different interventions in young women with primary dysmenorrhea:
Eligible participants will be women aged 18-25 years who meet the diagnostic criteria for primary dysmenorrhea based on gynecological examination and ultrasound findings. Participants will be randomly assigned into one of the three groups. All groups will undergo an 8-week supervised exercise program (two sessions per week) focusing on lumbopelvic stabilization, flexibility, and endurance training. In addition:
Primary outcome measures are:
Secondary outcome measures are:
Assessments will be conducted at baseline and after the 8-week intervention, within the first three days of menstruation. Additional follow-up data will be collected through online forms one month after the intervention to evaluate persistence of effects.
The estimated sample size of 51 was calculated considering a 10% attrition rate. Statistical analyses will be performed using SPSS software. Depending on data distribution, repeated measures ANOVA or non-parametric equivalents will be used to compare changes over time and between groups.
This study is expected to provide new evidence regarding the effectiveness of combining exercise with motor imagery or pain neuroscience education for the management of pain, menstrual symptoms, and cognitive flexibility in women with primary dysmenorrhea. The findings may contribute to the development of safe and effective non-pharmacological strategies in women's health and pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Only | Experimental | Participants will complete an 8-week supervised exercise program including lumbopelvic stabilization, stretching, and endurance training, delivered twice per week. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbopelvic Motor Control | Lumbopelvic motor control will be assessed using the Physioupplies Core Stabilizer Unit, which measures pressure changes during standardized stabilization tasks. | Baseline and after 8 weeks of intervention |
| Movement Imagery Ability |
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Inclusion Criteria:
Exclusion Criteria:
Only 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muge Dereli PhD Candidate in Physiotherapy and Rehabilitation, MSc | Contact | +905375069568 | mugedereli97@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydın Adnan Menderes University | Recruiting | Aydin | Efeler | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27351541 | Background | 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. | |
| 34190659 | Background | 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. |
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De-identified individual participant data (pain intensity scores, pressure pain threshold values, questionnaire results, and demographic data) will be shared
Data will be available beginning 6 months after study completion and will remain available for 5 years.
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.
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Exercise plus Motor Imagery Training | Behavioral | 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 plus Pain Neuroscience Education | Behavioral | 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. |
|
Participants' ability to generate and control movement imagery will be assessed using the Movement Imagery Questionnaire. Higher scores indicate better imagery ability. |
| Baseline |
| Central Sensitization | Central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI). The total score reflects symptom severity. | Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up |
| Cognitive Flexibility | Cognitive flexibility and inhibitory control will be assessed using the EncephalApp Stroop application. Participants will complete the "off" and "on" runs. Primary variables will be total completion time (seconds) and error count; lower times and fewer errors indicate better performance. | Baseline and after 8 weeks of intervention |
| Pain Catastrophizing | Catastrophic thinking related to pain will be assessed with the Pain Catastrophizing Scale, which includes rumination, magnification, and helplessness subscales. | Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up |
| Pain Resilience | Resilience in response to pain will be measured using the Pain Resilience Scale. Higher scores indicate better psychological resilience. | Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up |
| Pain Neurophysiology Knowledge | Participants' knowledge of pain mechanisms will be evaluated using the Revised Neurophysiology of Pain Questionnaire (NPQ). Higher scores indicate greater understanding of pain biology. The questionnaire will be administered to all participants at baseline (before the start of the intervention). In addition, it will be repeated only in the Pain Neuroscience Education (PNE) group immediately after the 8-week intervention and 1 month later to evaluate changes in knowledge. | Baseline (all groups); post-intervention and 1-month follow-up (PNE group only) |
| 39626586 | Background | 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. |
| 38963585 | Background | 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. |
| 31665789 | Background | 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |