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Recruiting NCT06212349

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

No phase Interventional Endometriosis Chronic Pain Women's Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: therapeutic-educational physiotherapy and pain education program, pain education program.
Who it may be relevant to
Registry conditions: Endometriosis, Chronic Pain, Women's Health. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other 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
  • 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.

Primary outcome measures

  • Musculoskeletal pain - Pressure pain threshold [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Musculoskeletal pain - quantitative Sensory Testing [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Musculoskeletal pain - pain drawing [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Musculoskeletal pain - Central Sensitisation Inventory [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
Secondary outcome measures (12)
  • Physical-Funcionality - Hand grip Strength [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - functional performance [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality- Pelvic floor Dynamometry [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - Body composition [Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - Motor control [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - Lumbar spine flexibility [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - Catastrophyzing [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Physical-Funcionality - Kinesophobia [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Quality of Life - Endometriosis [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Quality of Life - Gastrointestinal [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Quality of Life - Sexual Function [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
  • Quality of Life - Stress [Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitari i Politècnic La Fe, — Valencia

Identifiers

NCT: NCT06212349 · UV_Dep_FISIO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗