Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endometriosis Health Profile-30 (EHP-30) questionnaire
研究概览
简要总结
This randomized, sham-controlled, double-blinded clinical trial aims to investigate the effects of pulsed electromagnetic field therapy (PEMF) on pain intensity, quality of life, and pelvic floor morphometric changes assessed by four-dimensional trans perineal ultrasound (4D TPUS) in women diagnosed with endometriosis. Participants will be randomly allocated into either a PEMF therapy group or a sham PEMF control group. Both groups will continue receiving stable standard medical care throughout the study period. Assessments will be conducted at baseline, after completion of the 8-week intervention period, and at 3-month follow-up.
详细描述
Endometriosis is a chronic inflammatory gynecological disorder characterized by ectopic endometrial tissue growth and commonly associated with chronic pelvic pain, dysmenorrhea, dyspareunia, and impaired quality of life. Myofascial dysfunction and pelvic floor muscle hypertonia are increasingly recognized as contributing factors to persistent pain and pelvic floor dysfunction in women with endometriosis. Pulsed electromagnetic field therapy (PEMF) is a non-invasive physical modality with reported analgesic, anti-inflammatory, and tissue-healing effects in musculoskeletal and chronic pain disorders. However, evidence regarding its use in women with endometriosis remains limited. Therefore, this study aims to evaluate the effectiveness of PEMF therapy on pain severity, disease-specific quality of life, and pelvic floor morphometric changes assessed using four-dimensional trans perineal ultrasound (4D TPUS). The study will also investigate whether improvements in ultrasound-derived levator hiatal dimensions and pelvic floor relaxation are associated with clinically meaningful reductions in chronic pelvic pain.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. The sham device will appear identical to the active device in shape, sound, and operating indicators without delivering therapeutic electromagnetic output. Treating therapists will not participate in outcome assessment or data analysis.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 45 years
- •Clinically, radiologically, or laparoscopically diagnosed endometriosis
- •Chronic pelvic pain persisting for at least 6 months
- •Stable pharmacological or hormonal treatment for at least 3 months before enrollment
- •Ability to understand study procedures and provide written informed consent
排除标准
- •Pregnancy or planned pregnancy during the study period
- •History of gynecological or pelvic malignancy
- •Active pelvic inflammatory disease or acute pelvic infection
- •Implanted electronic medical devices such as pacemakers or neurostimulators
- •Previous pelvic surgery within the past 6 months
- •Participation in another clinical trial during the previous 3 months
- •Neurological, rheumatological, or severe musculoskeletal disorders affecting assessment procedures
- •Contraindications to electromagnetic therapy
研究组 & 干预措施
Pulsed Electromagnetic Field Therapy Group
Participants in this group will receive pulsed electromagnetic field therapy in addition to stable standard medical care.
干预措施: Pulsed Electromagnetic Field Therapy (Device)
Sham Pulsed Electromagnetic Field Therapy Group
Participants in this group will receive sham pulsed electromagnetic field therapy sessions in addition to stable standard medical care.
干预措施: Sham pulsed electromagnetic field therapy (Device)
结局指标
主要结局
Endometriosis Health Profile-30 (EHP-30) questionnaire
时间窗: Baseline, 8 weeks and at 3-month follow-up.
The Endometriosis Health Profile-30 questionnaire will be used to assess disease-specific quality of life. The EHP-30 evaluates pain, emotional well-being, control and powerlessness, social support, and self-image. Scores are transformed to a scale ranging from 0 to 100, with higher scores indicating poorer health-related quality of life.
次要结局
- Trans-perineal Ultrasound Assessment(Baseline, 8 weeks and 3-month follow-up.)
- Pain Intensity scale (VAS)(Baseline, 8 weeks and 3-month follow-up.)
研究者
Marwa Elsayed Mohamed, PhD
Lecturer of Physiotherapy for Women Health
Beni-Suef University