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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Musculoskeletal pain - Pressure pain threshold [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Musculoskeletal pain - quantitative Sensory Testing [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Musculoskeletal pain - pain drawing [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Musculoskeletal pain - Central Sensitisation Inventory [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]

Вторичные конечные точки (12)

• Physical-Funcionality - Hand grip Strength [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - functional performance [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality- Pelvic floor Dynamometry [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - Body composition [Срок оценки: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - Motor control [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - Lumbar spine flexibility [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - Catastrophyzing [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Physical-Funcionality - Kinesophobia [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Quality of Life - Endometriosis [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Quality of Life - Gastrointestinal [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Quality of Life - Sexual Function [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]
• Quality of Life - Stress [Срок оценки: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitari i Politècnic La Fe, — Valencia

Идентификаторы

NCT: NCT06212349 · UV_Dep_FISIO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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