Pelvic Floor Physical Therapy and Exercise for Women With Endometriosis and Chronic Pelvic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pelvic Floor Physical Therapy, Placebo Pelvic Floor Physical Therapy, Physical Exercise.
- Who it may be relevant to
- Registry conditions: Endometriosis, Chronic Pelvic Pain. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pelvic Floor Physical Therapy and Physical Exercise Versus Placebo for the Treatment of Endometriosis With Chronic Pelvic Pain: A Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral Pelvic Floor Physical Therapy
Specialized pelvic floor physical therapy administered over 12 weeks, including individualized assessment and evidence-based treatment targeting pelvic floor dysfunction associated with endometriosis-related chronic pelvic pain. Treatment may include manual therapy, pelvic floor muscle training, therapeutic exercises, education, and other physiotherapy techniques according to participants' clinical findings. - Behavioral Placebo Pelvic Floor Physical Therapy
Placebo pelvic floor physical therapy administered over 12 weeks using procedures designed to maintain participant blinding without providing specific therapeutic effects. Participants will receive the same number and duration of sessions as the experimental group. - Behavioral Physical Exercise
A structured progressive physical exercise program administered over 12 weeks, consisting of six progressive phases and provided equally to participants in both study arms.
Primary outcome measures
- Chronic Pelvic Pain Intensity [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
Secondary outcome measures (12)
- Neuropathic Pain Symptoms (painDETECT) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Central Sensitization Symptoms (CSI-A) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Female Sexual Function (FSFI) [Time frame: 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) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- General Quality of Life (WHOQOL-BREF) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Depressive Symptoms (BDI) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Treatment Adherence [Time frame: Throughout the 12-session intervention (approximately 12 weeks).]
- Participant Satisfaction [Time frame: After completion of the 12-session intervention (approximately 12 weeks).]
- Pelvic Floor Muscle Strength (Modified Oxford Scale) [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Pelvic Floor Muscle Endurance [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Repetitions of Sustained Contractions [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
- Fast Contractions [Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Hospital de Clínicas de Porto Alegre — Porto Alegre
Identifiers
NCT: NCT07733583 · 2025-0492