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

NCT06212349 | Recruiting

• 1 other identifier: UV_Dep_FISIO
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Chronic Pain; Women's Health

Keywords

endometriosis; Chronic Pain; Physical Therapy; Health education; Women

Outcome Measures

Primary Outcomes (4)

• Musculoskeletal pain - Pressure pain threshold

  Pressure pain threshold measured in rectus abdominis and lumbar muscles

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Musculoskeletal pain - quantitative Sensory Testing

  Quantitative sensory testing is a non-invasive technique used to assess and quantify sensory functions by determining sensation and pain thresholds using pressure.

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Musculoskeletal pain - pain drawing

  Identification of pain areas through a pain map: this consists of a human figure on a two-dimensional plane on which the patient can express the representation of the pain areas on a schematic of the body surface.

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Musculoskeletal pain - Central Sensitisation Inventory

  Central Sensitisation Inventory: is a self-report instrument that indirectly assesses somatic and emotional symptoms that have been found to be associated with Central Sensitisation.

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

Secondary Outcomes (17)

• Physical-Funcionality - Hand grip Strength

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Physical-Funcionality - functional performance

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Physical-Funcionality- Pelvic floor Dynamometry

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Physical-Funcionality - Body composition

  3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

• Physical-Funcionality - Motor control

  assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

Study Arms (2)

Experimental

EXPERIMENTAL

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

Other: therapeutic-educational physiotherapy and pain education program

Control

OTHER

They will receive the pain education program.

Other: pain education program

Interventions

therapeutic-educational physiotherapy and pain education program 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.

Experimental

pain education program 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.

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Universitario La Fe: collaborator
• Instituto de Investigacion Sanitaria La Fe: collaborator

Study Sites (1)

Hospital Universitari i Politècnic La Fe,

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Endometriosis; Chronic Pain; Health Education

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• laura Fuentes Aparicio, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Juarez, MD

CONTACT

961244000; ijuapa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: February 9, 2024
• Primary Completion: December 14, 2024
• Study Completion (Estimated): December 22, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)