An interventional study of Pelvic Floor Physical Therapy and Placebo Pelvic Floor Physical Therapy in Endometriosis and Chronic Pelvic Pain, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
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.
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.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's planned enrollment of 64 is close to the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will receive specialized pelvic floor physical therapy combined with a structured progressive physical exercise program for 12 weeks.
Behavioral: Pelvic Floor Physical Therapy · Behavioral: Physical Exercise
Participants assigned to this arm will receive a placebo pelvic floor physical therapy intervention combined with the same structured progressive physical exercise program for 12 weeks.
Behavioral: Placebo Pelvic Floor Physical Therapy · Behavioral: Physical Exercise
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.
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.
A structured progressive physical exercise program administered over 12 weeks, consisting of six progressive phases and provided equally to participants in both study arms.
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).
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).
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).
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).
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).
General Quality of Life (WHOQOL-BREF)
Health-related quality of life will be assessed using the World Health Organization Quality of Life Instrument, Brief Version (WHOQOL-BREF), a 26-item questionnaire that assesses four domains: physical health, psychological health, social relationships, and environment. The outcome is the change in domain scores 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).
Depressive Symptoms (BDI)
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The outcome is the change in the total BDI 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).
Treatment Adherence
Treatment adherence will be assessed throughout the intervention by recording attendance at supervised treatment sessions and adherence to the prescribed home exercise program using participant adherence records.
Time frame: Throughout the 12-session intervention (approximately 12 weeks).
Participant Satisfaction
Participant satisfaction will be assessed after completion of the 12-session intervention using a study-specific questionnaire composed of 13 items rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Individual item responses will be analyzed to evaluate participants' perceptions of the intervention.
Time frame: After completion of the 12-session intervention (approximately 12 weeks).
Pelvic Floor Muscle Strength (Modified Oxford Scale)
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale during standardized digital vaginal examination. The outcome is the change in muscle strength score from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 0 to 5, with higher scores indicating greater pelvic floor muscle strength.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Pelvic Floor Muscle Endurance
Pelvic floor muscle endurance will be assessed as the maximum duration of a sustained voluntary pelvic floor muscle contraction during standardized digital vaginal examination. The outcome is the change in contraction duration from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Endurance is recorded in seconds, with higher values indicating greater 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
Pelvic floor muscle repetitions will be assessed as the number of sustained voluntary contractions performed before fatigue during standardized digital vaginal examination. The outcome is the change in the number of repetitions from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Higher values indicate greater muscular endurance.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Fast Contractions
Fast pelvic floor muscle contractions will be assessed as the maximum number of rapid voluntary contractions completed in sequence during standardized digital vaginal examination. The outcome is the change in the number of fast contractions from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Higher values indicate better pelvic floor muscle performance.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Resting Pelvic Floor Muscle Tone
Resting pelvic floor muscle tone will be assessed during standardized digital vaginal examination. The outcome is the change in resting muscle tone classification from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Muscle tone is classified as hypotonic, normal, or hypertonic.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Pelvic Floor Muscle Relaxation
Pelvic floor muscle relaxation will be assessed during standardized digital vaginal examination following maximal voluntary contraction. The outcome is the change in relaxation ability from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Relaxation is classified as complete, partial, or absent.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Pain on Palpation
Pain on pelvic floor muscle palpation will be assessed during standardized digital vaginal examination. The outcome is the change in the presence or absence of pain on palpation 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).
Pain Intensity on Palpation (Visual Analog Scale - VAS)
Pain intensity during pelvic floor muscle palpation will be assessed using the Visual Analog Scale (VAS). The outcome is the change in pain intensity score from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Pain Location on Palpation
Pain location during standardized digital vaginal examination will be assessed by documenting the anatomical location(s) in which pain is reported during pelvic floor muscle palpation. The outcome is the change in pain location from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Pain location is recorded as superficial, deep, rectal, or other.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Pelvic Floor Muscle Elevation
Pelvic floor muscle elevation during voluntary contraction will be assessed during standardized digital vaginal examination. The outcome is the change in the presence of cranial elevation of the pelvic floor muscles from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Elevation is classified as present or absent.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Co-contraction
Co-contraction will be assessed during standardized digital vaginal examination by recording activation of synergistic muscles during voluntary pelvic floor muscle contraction. The outcome is the change in co-contraction pattern from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Co-contraction is classified as none, transversus abdominis, gluteal muscles, adductor muscles, multiple muscles, or other.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Timing
Timing of pelvic floor muscle contraction will be assessed by evaluating the ability to voluntarily contract the pelvic floor muscles before or simultaneously with increased intra-abdominal pressure during standardized digital vaginal examination. The outcome is the change in timing classification from baseline to after 8 treatment sessions and after completion of the 12-session intervention. Timing is classified as present or absent.
Time frame: Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks).
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 18 months is below that.
Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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