Pelvic Floor Physical Therapy and Physical Exercise Versus Placebo for the Treatment of Endometriosis With Chronic Pelvic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Chronic Pelvic Pain Intensity
研究概览
简要总结
Endometriosis is a chronic gynecological condition that can cause persistent pelvic pain, painful menstruation, painful sexual intercourse, and reduced quality of life. This study will evaluate whether specialized pelvic floor physical therapy combined with a structured physical exercise program is more effective than a placebo intervention combined with the same exercise program in reducing chronic pelvic pain in women with endometriosis. Participants will be randomly assigned to one of the two groups and followed for 12 weeks.
详细描述
Endometriosis is a chronic estrogen-dependent inflammatory disease frequently associated with chronic pelvic pain, dysmenorrhea, dyspareunia, impaired quality of life, sexual dysfunction, and central pain sensitization. Although pelvic floor physical therapy and exercise have demonstrated potential benefits, high-quality randomized placebo-controlled trials evaluating their combined effects remain limited.
This study is a prospective, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the effectiveness of specialized pelvic floor physical therapy combined with a structured physical exercise program compared with a placebo intervention combined with the same exercise program in women with confirmed endometriosis and chronic pelvic pain.
Sixty-four participants will be randomly allocated (1:1) to either the intervention group or the placebo group. Both groups will participate in the same 12-week progressive exercise program. The intervention group will receive specialized pelvic floor physical therapy, whereas the control group will receive a placebo pelvic floor physical therapy protocol designed to maintain participant blinding without providing specific therapeutic effects.
Participants will be evaluated at baseline (week 0), after 8 weeks, and at the end of the 12-week intervention. The primary outcome is the intensity of chronic pelvic pain. Secondary outcomes include neuropathic pain symptoms, central sensitization, quality of life, sexual function, depressive symptoms, pelvic floor muscle function, treatment adherence, and participant satisfaction.
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 treatment allocation. The physical therapist delivering the interventions will not be blinded because of the nature of the interventions.
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
- •Female, aged 18 to 45 years.
- •Diagnosis of endometriosis confirmed by surgery and/or imaging examinations.
- •Chronic pelvic pain for at least 6 months.
- •Visual Analog Scale (VAS) score ≥4 for chronic pelvic pain.
- •Willingness and ability to provide written informed consent and comply with all study procedures.
排除标准
- •Current pregnancy or planned pregnancy during the study period.
- •Pelvic surgery within the previous 3 months.
- •Neuromodulation treatment within the previous 3 months.
- •Medical or musculoskeletal conditions that contraindicate participation in pelvic floor physical therapy or the exercise program.
结局指标
主要结局
Chronic Pelvic Pain Intensity
时间窗: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
The primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale in which 0 indicates no pain and 10 indicates the worst pain imaginable, for chronic pelvic pain, dysmenorrhea, and dyspareunia, from baseline to Week 8 and Week 12.
次要结局
- Neuropathic Pain Symptoms (painDETECT)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Central Sensitization Symptoms (CSI-A)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Female Sexual Function (FSFI)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Endometriosis-Specific Quality of Life (EHP-30)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- General Quality of Life (WHOQOL-BREF)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Depressive Symptoms (BDI)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Treatment Adherence(Throughout the 12-session intervention (approximately 12 weeks).)
- Participant Satisfaction(After completion of the 12-session intervention (approximately 12 weeks).)
- Pelvic Floor Muscle Strength (Modified Oxford Scale)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pelvic Floor Muscle Endurance(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Repetitions of Sustained Contractions(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Fast Contractions(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Resting Pelvic Floor Muscle Tone(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pelvic Floor Muscle Relaxation(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pain on Palpation(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pain Intensity on Palpation (Visual Analog Scale - VAS)(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pain Location on Palpation(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Pelvic Floor Muscle Elevation(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Co-contraction(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)
- Timing(Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).)