Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis.

NCT ID: NCT06212349

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2026-12-22

Brief Summary

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This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program.

The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.

Detailed Description

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Conditions

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Endometriosis Chronic Pain Women's Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Experimental

They will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program,

Group Type EXPERIMENTAL

therapeutic-educational physiotherapy and pain education program

Intervention Type OTHER

The EG will carry out a total of 24 sessions, at a rate of 3 weekly sessions of 30 minutes each. The first session of each month will be in person and the rest will be done at home following video tutorials with an App (https://fisiotrack.com). The face-to-face sessions will be conducted by a women's health physiotherapist, and will consist on therapeutic exercises based on body awareness, motor control and respiratory awareness.They will also receive a pain education program with indications on pain education, as well as basic information and general advice on the positive effects of physical activity and a healthy lifestyle for endometriosis. In addition, biweekly supervision will be carried out via telephone or video conference by a specialized physiotherapist.

Control

They will receive the pain education program.

Group Type OTHER

pain education program

Intervention Type OTHER

They will receive instructions on pain education, as well as basic information and general advice about the positive effects of physical activity and a healthy lifestyle for your endometriosis, in writing via email. In addition, they will receive biweekly supervision via telephone or video conference by a specialized physical therapist.

Interventions

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therapeutic-educational physiotherapy and pain education program

The EG will carry out a total of 24 sessions, at a rate of 3 weekly sessions of 30 minutes each. The first session of each month will be in person and the rest will be done at home following video tutorials with an App (https://fisiotrack.com). The face-to-face sessions will be conducted by a women's health physiotherapist, and will consist on therapeutic exercises based on body awareness, motor control and respiratory awareness.They will also receive a pain education program with indications on pain education, as well as basic information and general advice on the positive effects of physical activity and a healthy lifestyle for endometriosis. In addition, biweekly supervision will be carried out via telephone or video conference by a specialized physiotherapist.

Intervention Type OTHER

pain education program

They will receive instructions on pain education, as well as basic information and general advice about the positive effects of physical activity and a healthy lifestyle for your endometriosis, in writing via email. In addition, they will receive biweekly supervision via telephone or video conference by a specialized physical therapist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of endometriosis made by imaging techniques (MRI or ultrasound) or by surgery.
* A period of 3 months or more since the last surgery if they have undergone surgery.
* Who are receiving hormone treatment and have their disease under control.
* Persistent pelvic pain for at least 3 months.
* With pain and hypertonus in the pelvic musculature, myofascial syndrome, vestibulodynia or pudendal neuropathy.
* Consent to participate in the study
* Capable of carrying out the follow-up of the study until the final visit.
* Who have audiovisual resources and the internet at their disposal.

Exclusion Criteria

* Women in the menopausal phase
* Women undergoing fertility treatment or planning to undergo fertility treatment in the next 3 months.
* Pregnant women.
* Women undergoing physiotherapy treatment or who have undergone physiotherapy treatment in the last 3 months.
* Having suffered a fracture in the last 3 months in the lower limb that limits their functional capacity.
* Cognitive illness that prevents correct comprehension of the exercises.
* Musculoskeletal pathology or neuropathy in acute phase.
* Having suffered or suffering from a neoplastic disease.
* Untreated endometriosis
* Acquired genital abnormalities of the pelvis or pelvic floor.
* Women in a situation of litigation or economic compensation, or pending the granting of a degree of disability.
* Severe mental illness (schizophrenia, borderline personality disorder, etc.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Fe

OTHER

Sponsor Role collaborator

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Laura Fuentes Aparicio

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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laura Fuentes Aparicio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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Hospital Universitari i Politècnic La Fe,

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Irene Juarez, MD

Role: CONTACT

961244000

Facility Contacts

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Iren Juarez, MD

Role: primary

961244000

Other Identifiers

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UV_Dep_FISIO

Identifier Type: -

Identifier Source: org_study_id

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