Pelvic Floor Physical Therapy and Exercise for Women With Endometriosis and Chronic Pelvic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHospital de Clinicas de Porto Alegre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pelvic Floor Physical Therapy
BehavioralSpecialized 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.
Placebo Pelvic Floor Physical Therapy
BehavioralPlacebo 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.
Physical Exercise
BehavioralA structured progressive physical exercise program administered over 12 weeks, consisting of six progressive phases and provided equally to participants in both study arms.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Pelvic Floor Physical Therapy Plus Physical ExerciseExperimental treatment 2 interventions
Group B: Placebo Pelvic Floor Physical Therapy Plus Physical ExercisePlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Chronic Pelvic Pain Intensity
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.
Time frame
Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).Secondary outcomes
1
Neuropathic Pain Symptoms (painDETECT)
Neuropathic pain symptoms will be assessed using the painDETECT questionnaire. The outcome is the change in the total painDETECT score from baseline to after 8 treatment sessions and after completion of the 12-session intervention.
Time frame
Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).2
Central Sensitization Symptoms (CSI-A)
Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI-A). The outcome is the change in the total CSI-A score from baseline to after 8 treatment sessions and after completion of the 12-session intervention.
Time frame
Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).3
Female Sexual Function (FSFI)
Female sexual function will be assessed using the Female Sexual Function Index (FSFI). The outcome is the change in the total FSFI score from Baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 2 to 36 points, with higher scores indicating better female sexual function.
Time frame
Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).4
Endometriosis-Specific Quality of Life (EHP-30)
Health-related quality of life will be assessed using the Endometriosis Health Profile-30 (EHP-30). The EHP-30 is a 30-item questionnaire assessing five core domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Scores for each domain are transformed to a standardized 0-100 scale, with higher scores indicating worse health-related quality of life.
Time frame
Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital de Clinicas de Porto Alegre
Lead sponsor
Federal University of Rio Grande do Sul
Collaborator
Source ClinicalTrials.gov