Aydın Adnan Menderes University
Aydin, Efeler, Turkey (Türkiye)
NCT Number: NCT07196150
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
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Notify Me18 year–25 year
Female
Interventional
Not applicable
Aydin, Efeler, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up
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.
Time frame: Baseline and after 8 weeks of intervention (first three days of menstruation)
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.
Time frame: Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up
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.
Time frame: Baseline and after 8 weeks of intervention
Lumbopelvic motor control will be assessed using the Physioupplies Core Stabilizer Unit, which measures pressure changes during standardized stabilization tasks.
Time frame: Baseline
Participants' ability to generate and control movement imagery will be assessed using the Movement Imagery Questionnaire. Higher scores indicate better imagery ability.
Time frame: Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up
Central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI). The total score reflects symptom severity.
Time frame: Baseline and after 8 weeks of intervention
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.
Time frame: Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up
Catastrophic thinking related to pain will be assessed with the Pain Catastrophizing Scale, which includes rumination, magnification, and helplessness subscales.
Time frame: Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up
Resilience in response to pain will be measured using the Pain Resilience Scale. Higher scores indicate better psychological resilience.
Time frame: Baseline (all groups); post-intervention and 1-month follow-up (PNE group only)
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.
Muge Dereli
Other
Comparison of the Effects of Exercise, Motor Imagery Training, and Pain Neuroscience Education on Pain, Menstrual Symptoms, and Cognitive Flexibility in Women With Primary Dysmenorrhea: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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