Endometriosis, Chronic Pelvic Pain
Conditions
Keywords
Pelvic Floor Physical Therapy, Chronic Pelvic Pain, Endometriosis, Randomized Controlled Trial, Physical Exercise, Quality of Life, Dyspareunia, Dysmenorrhea
Brief summary
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
BEHAVIORALPelvic 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.
BEHAVIORALPlacebo 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.
BEHAVIORALPhysical 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.
Sponsors
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the placebo control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pelvic Pain Intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Symptoms (painDETECT) | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Central Sensitization Symptoms (CSI-A) | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Female Sexual Function (FSFI) | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| 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). | 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. |
| General Quality of Life (WHOQOL-BREF) | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Depressive Symptoms (BDI) | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Treatment Adherence | Throughout the 12-session intervention (approximately 12 weeks). | 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. |
| Participant Satisfaction | After completion of the 12-session intervention (approximately 12 weeks). | 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. |
| 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 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. |
| Pelvic Floor Muscle Endurance | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Repetitions of Sustained Contractions | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Fast Contractions | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Resting Pelvic Floor Muscle Tone | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Pelvic Floor Muscle Relaxation | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Pain on Palpation | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| 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 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. |
| Pain Location on Palpation | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Pelvic Floor Muscle Elevation | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Co-contraction | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
| Timing | Baseline; after 8 treatment sessions (approximately 8 weeks); after completion of the 12-session intervention (approximately 12 weeks). | 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. |
Countries
Brazil
Contacts
CONTACTPriscila Peixoto da Fonseca, PT, MSc Candidate
STUDY_DIRECTORJoão da Cunha Filho, PhD
Hospital de Clínicas de Porto Alegre
Outcome results
None listed