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临床试验/NCT07196150
NCT07196150已完成不适用

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

Muge Dereli1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2025年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Pressure Pain Threshold (PPT)

研究概览

简要总结

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

详细描述

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:

  • Exercise only (control group)
  • Exercise plus Motor Imagery Training
  • Exercise plus Pain Neuroscience Education (PNE)

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:

  • The Motor Imagery group will practice kinesthetic visualization of the exercises prior to performing them.
  • The PNE group will receive weekly face-to-face education sessions on pain mechanisms, supported with home assignments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Exercise Only

Experimental

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

干预措施: Exercise Program (Behavioral)

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.

干预措施: Exercise Program (Behavioral)

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.

干预措施: Exercise plus Motor Imagery Training (Behavioral)

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.

干预措施: Exercise Program (Behavioral)

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.

干预措施: Exercise plus Pain Neuroscience Education (Behavioral)

结局指标

主要结局

Pressure Pain Threshold (PPT)

时间窗: 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.

Menstrual Symptom Severity

时间窗: 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.

Pain Intensity

时间窗: 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.

次要结局

  • 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)
  • Pain Resilience(Baseline, after 8 weeks of intervention, and 1 month post-intervention follow-up)
  • Pain Neurophysiology Knowledge(Baseline (all groups); post-intervention and 1-month follow-up (PNE group only))

研究者

发起方
Muge Dereli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muge Dereli

Professor Derya Ozer Kaya, PhD - Principal Investigator; Professor of Physiotherapy and Rehabilitation

Izmir Katip Celebi University

研究点 (1)

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