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NCT Number: NCT06212349

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

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.

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Key information

Conditions

Endometriosis Adherence Interventions Behavior Chronic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Health Behavior Health Education Medication Adherence Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Treatment Adherence and Compliance Urogenital Diseases Women's Health

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari i Politècnic La Fe,

Valencia, 46026, Spain

Location status: Recruiting

Location contact

Iren Juarez, MD

CONTACT

[email protected]

961244000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

Primary outcomes

  1. Musculoskeletal pain - Pressure pain threshold

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

    Pressure pain threshold measured in rectus abdominis and lumbar muscles

  2. Musculoskeletal pain - quantitative Sensory Testing

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

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

  3. Musculoskeletal pain - pain drawing

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

    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.

  4. Musculoskeletal pain - Central Sensitisation Inventory

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

    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.

Secondary outcomes

  1. Physical-Funcionality - Hand grip Strength

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

    Hand grip strength will be measured by the handgrip strength technique using a Jamar Plus+ digital hand dynamometer.

  2. Physical-Funcionality - functional performance

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

    To assess functional performance patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 s (30 second- Sit to stand).

  3. Physical-Funcionality- Pelvic floor Dynamometry

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

    Dynamometry of the pelvic floor muscles: measurement of basal tone (g) and tone at maximum contraction (Phenix Liberty Dynamometer).

  4. Physical-Funcionality - Body composition

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

    Body composition (% fat, % water, % muscle): record body composition (skeletal muscle mass and % body fat) with a bioimpedance scale (DC-430MA, Tanita Corporation of America, Inc, Arlignton Heights, IL, USA).

  5. Physical-Funcionality - Motor control

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

    Determine motor control: clinical test of lumpopelvic and thoracolumbar dissociation will be used.

  6. Physical-Funcionality - Lumbar spine flexibility

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

    Lumbar spine flexibility: It will be measured with the Schöber test

  7. Physical-Funcionality - Catastrophyzing

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

    Catastrophyzing: to assess catastrophic thinking related to pain the Pain Catastrophyzing Scale (PCS) will be used

  8. Physical-Funcionality - Kinesophobia

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

    Kinesophobia: it will be assessed with the Tampa Scale for Kinesophobia-11 (TSK-11), which consists of 11 items.

  9. Quality of Life - Endometriosis

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

    Quality of life will be assessed using the Spanish version of the Endometriosis Health Profile-30 (EHP-30).

  10. Quality of Life - Gastrointestinal

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

    Quality of life at the gastrointestinal level will be assessed using the Gastrointestinal Quality of Life Index, which addresses 5 domains (digestive symptoms, physical state, emotions, social dysfunction and effects of medical treatment).

  11. Quality of Life - Sexual Function

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

    the abbreviated Index of Female Sexual Function (IFSF-6) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function

  12. Quality of Life - Stress

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

    Stress using the Perceived stress scale (PSQ).

  13. Biomarkers - Inflamation

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

    Plasma markers of chronic inflammation and intestinal permeability will be assessed including a multiplex array of inflammation markers, and as specific markers of chronic inflammation associated with intestinal permeability, zonulin, C-reactive protein, Binding Protein , and bactericidal/permeability-increasing protein will be assessed.

  14. Patient's satisfaction

    Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

    Satisfaction with the treatment received will be assessed using the Satisfaction with Treatment Received Scale (CRES-4).

  15. Patient's perception of change

    Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

    Patient's Perception of change after the treatment will be measured by patients' global impression of change (PGIC) in a quantitative and qualitative way.

  16. APP usability

    Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

    A questionnaire on the usability of the application will be used. System Usability Scale.

  17. Adherence to treatment

    Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)

    Adherence to treatment: in the experimental group it will be measured through the records made in the application https://fisiotrack.com/, in the control group it will be measured through an ad hoc activity diary that will be provided to them.

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Juarez, MD

CONTACT

[email protected]

961244000

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital Universitario La Fe
  • Instituto de Investigacion Sanitaria La Fe

Registry information

Official study 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

Acronym: PHYSIO_ENDOM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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