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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Valencia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • therapeutic-educational physiotherapy and pain education program

    Other intervention

    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 intervention

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

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University of Valencia

Lead sponsor

Hospital Universitario La Fe

Collaborator

Instituto de Investigacion Sanitaria La Fe

Collaborator