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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
| Instituto de Investigacion Sanitaria La Fe | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | They will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, |
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| Control | Other | They will receive the pain education program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Musculoskeletal pain - Pressure pain threshold | Pressure pain threshold measured in rectus abdominis and lumbar muscles | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical-Funcionality - Hand grip Strength | Hand grip strength will be measured by the handgrip strength technique using a Jamar Plus+ digital hand dynamometer. | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality - functional performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Juarez, MD | Contact | 961244000 | ijuapa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| laura Fuentes Aparicio, PhD | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari i Politècnic La Fe, | Recruiting | Valencia | 46026 | Spain |
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| 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. |
|
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 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality- Pelvic floor Dynamometry | Dynamometry of the pelvic floor muscles: measurement of basal tone (g) and tone at maximum contraction (Phenix Liberty Dynamometer). | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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). | 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality - Motor control | Determine motor control: clinical test of lumpopelvic and thoracolumbar dissociation will be used. | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality - Lumbar spine flexibility | Lumbar spine flexibility: It will be measured with the Schöber test | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality - Catastrophyzing | Catastrophyzing: to assess catastrophic thinking related to pain the Pain Catastrophyzing Scale (PCS) will be used | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Physical-Funcionality - Kinesophobia | Kinesophobia: it will be assessed with the Tampa Scale for Kinesophobia-11 (TSK-11), which consists of 11 items. | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Quality of Life - Endometriosis | Quality of life will be assessed using the Spanish version of the Endometriosis Health Profile-30 (EHP-30). | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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). | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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 | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Quality of Life - Stress | Stress using the Perceived stress scale (PSQ). | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| Patient's satisfaction | Satisfaction with the treatment received will be assessed using the Satisfaction with Treatment Received Scale (CRES-4). | assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| APP usability | A questionnaire on the usability of the application will be used. System Usability Scale. | assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| 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. | assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention) |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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