Clinical trial NCT06212349: Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis.
Official title: Effect of a Therapeutic-educational Physiotherapy Program on Pain and the Physical-functional Sphere in Women With Endometriosis and Its Impact on Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Chronic Pain
Women's Health
Keywords: endometriosis
Chronic Pain
Physical Therapy
Health education
Women
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: Instituto de Investigacion Sanitaria La Fe
First posted: 2024-01-18
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Musculoskeletal pain - Pressure pain threshold
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Musculoskeletal pain - quantitative Sensory Testing
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Musculoskeletal pain - pain drawing
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Musculoskeletal pain - Central Sensitisation Inventory
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Secondary outcomes:
measure: Physical-Funcionality - Hand grip Strength
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - functional performance
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality- Pelvic floor Dynamometry
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - Body composition
timeFrame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - Motor control
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - Lumbar spine flexibility
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - Catastrophyzing
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Physical-Funcionality - Kinesophobia
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Quality of Life - Endometriosis
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Quality of Life - Gastrointestinal
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Quality of Life - Sexual Function
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Quality of Life - Stress
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Biomarkers - Inflamation
timeFrame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Patient's satisfaction
timeFrame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Patient's perception of change
timeFrame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: APP usability
timeFrame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
measure: Adherence to treatment
timeFrame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe,
Study officials:
affiliation: University of Valencia
name: laura Fuentes Aparicio, PhD
role: PRINCIPAL_INVESTIGATOR
References: