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RecruitingNCT06212349PHYSIO_ENDOMUpdated May 19, 2026

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

An interventional study of therapeutic-educational physiotherapy and pain education program and pain education program in Endometriosis, Chronic Pain and Women's Health, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometriosis
  • Chronic Pain
  • Women's Health

Keywords

  • endometriosis
  • Chronic Pain
  • Physical Therapy
  • Health education
  • Women
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's planned enrollment of 62 is close to the median of 64 across 525 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • 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

  • Other
    Control

    They will receive the pain education program.

    Other: pain education program

Interventions

  • Othertherapeutic-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 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.

  • Otherpain 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.

06

What researchers measure

Primary outcomes

  1. Musculoskeletal pain - Pressure pain threshold

    Pressure pain threshold measured in rectus abdominis and lumbar muscles

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. Physical-Funcionality - Hand grip Strength

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

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

  2. Physical-Funcionality - functional performance

    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).

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

  3. Physical-Funcionality- Pelvic floor Dynamometry

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

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

  4. Physical-Funcionality - Body composition

    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).

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

  5. Physical-Funcionality - Motor control

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

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

  6. Physical-Funcionality - Lumbar spine flexibility

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

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

  7. Physical-Funcionality - Catastrophyzing

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

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

  8. Physical-Funcionality - Kinesophobia

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

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

  9. Quality of Life - Endometriosis

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

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

  10. Quality of Life - Gastrointestinal

    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).

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

  11. Quality of Life - Sexual Function

    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

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

  12. Quality of Life - Stress

    Stress using the Perceived stress scale (PSQ).

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

  13. Biomarkers - Inflamation

    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.

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

  14. Patient's satisfaction

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

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

  15. Patient's perception of change

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

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

  16. APP usability

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

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

  17. Adherence to treatment

    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.

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

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitari i Politècnic La Fe,
    Valencia, 46026, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06212349
Lead sponsor
University of Valencia
Collaborators
Hospital Universitario La Fe, Instituto de Investigacion Sanitaria La Fe
Responsible party
Laura Fuentes Aparicio (Doctor, University of Valencia) — Principal investigator
First posted
Jan 18, 2024
Start date
Sep 9, 2024
Primary completion
Sep 9, 2027 (estimated)
Completion
Dec 22, 2027 (estimated)
Last update
May 19, 2026

Study contacts

Irene Juarez, MD
Contact
ijuapa@gmail.com
961244000
laura Fuentes Aparicio, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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