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

Chronic Pain Clinical Trial

— PHYSIO_ENDOM  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212349
• Other study ID #: UV_Dep_FISIO
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: December 22, 2026

Study information

• Verified date: January 2024
• Source: University of Valencia
• Contact: Irene Juarez, MD
• Phone: 961244000
• Email: ijuapa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 22, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Chronic Pain
• Endometriosis
• Women's Health

Intervention

Other:
• 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 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
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari i Politècnic La Fe,	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Hospital Universitario La Fe, Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	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).	3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)