Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.

NCT06795243 | Recruiting

• 1 other identifier: SICEIA 2024-146
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to know if the application of both therapies, neuroscience pain education plus therapeutic exercise will modify pain, catastrophizing and quality of life in endometriosis.

Conditions

Endometriosis; Endometriosis Related Pain; Pain; Therapeutic Exercise; Exercise Adherence; Adherence, Treatment; Treatment Adherence and Compliance; Quality of Life; Endometriosis, Pain; Endometriosis-related Pain; Pain Intensity Assessment; Pain Management; Pain, Chronic Disease; Pain Score

Keywords

Endometriosis; Endometriosis Related Pain; Endometriosis, Pain; Pain; Pain Intensity Assessment; Pain Management; Pain, chronic disease; pain score; therapeutic exercise; exercise adherence; Adherence, Treatment; Treatment Adherence and Compliance; Quality of life

Outcome Measures

Primary Outcomes (6)

• Change from Self-report Pain magnitude

  Magnitude of chronic pain: Chronic pain grading scale. Likert-type scale with 8 items that are evaluated between 0 and 10 for items 2, 3, 4, 6, 7 and 8. Item 1 collects the number of days with pain in the last six months. Item 5 rates the impediment to the performance of usual tasks in the last three months, and can be evaluated between none and 90. The higher the score, the greater the chronic pain involvement. If the score is zero, the patient will be rated as having no pain. Chronic pain will be of low interference with grade I (low intensity) or grade II (high intensity) or of high interference with grade III (moderately limiting) or grade IV (severely limiting). Persistence will be graded as non-persistent or persistent pain.

  At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week

• Treatment Compliance

  Self-report of the person responsible for managing attendance at the group sessions in the experimental group. Participants who attend 80% or more of the sessions will be considered compliant.

  From enrollment to the end of treatment at 8 weeks

• Treatment adherence (Maintenance of the therapeutic exercise program at home )

  Adherence to treatment (experimental group), measured by visual analogue scale (VAS) included in the patient diary, in terms of: Maintenance of treatment at home: number of days that the proposed exercise is performed (100% being 3 times a week). Each patient will complete the VAS scale weekly. Participants with a score equal to or greater than 80 points out of 100 on the VAS scale will be considered to have high adherence.

  From the end of the intervention at 8 weeks (starting at week 9) to the end of treatment at 32 weeks

• Changes from Self-report pain catastrophizing

  Catastrophizing thoughts in the face of pain: Pain Catastrophizing Scale (PCS). Pain catastrophizing is a construct that is related to a negative and exaggerated orientation towards painful stimuli. The scale, validated in Spanish, is a list of 13 statements that describe different thoughts and feelings that may be related to pain in the dimensions of rumination, magnification and hopelessness. The person indicates the degree to which he/she has such thoughts or feelings by rating them between 0 (not at all) and 4 (all the time). The theoretical range of the instrument is between 13 and 62, with higher values indicating a higher index of catastrophizing.

  At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week

• Change from Self-report specific quality of life

  Specific quality of life: Endometriosis Health Profile (EHP-30+23) questionnaire Spanish version. The questionnaire is composed of two parts. Part 1 with 30 itmens and part 2 divided into five subscales: pain, control and helplessness, emotional well-being, social support and self-image. For part 1 and each subscale a total score is created as a percentage of the maximum possible score. 0 is considered the best possible health status and 100 the worst.

  At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week

• Changes in self-reported general quality of life

  Overall Quality of Life: EUROQOL-5 Dimensions- 3 Levels (EQ-5D-3L). It is a standardized instrument that measures health outcomes and is applicable to a wide range of diseases and treatments. It provides a simple descriptive profile and a single index of health status. The EQ-5D-3L covers 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed in 3 categories (no problems; moderate problems; extreme problems). The assessment consists of measuring each of the 5 domains in one of the 3 categories. In this work we use, as in our reference study, the validated Spanish version of the EQ-5D-3L in its current version for the adult population. EQ-5D © 2025 EuroQol Research Foundation.

  At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week

Secondary Outcomes (1)

• Exercise-related adverse events

  At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week

Study Arms (2)

Experimental Group

EXPERIMENTAL

Application of a multimodal physical therapy program based on pain education and therapeutic exercise. Sixteen sessions will be carried out. The sessions will be carried out with a frequency of two days a week. Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE), and 8 weeks (2 times/ week) of therapeutic exercise.

Procedure: PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM

Control Group

ACTIVE COMPARATOR

Usual Care. Application of standard medical treatment. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients.

Procedure: USUAL CARE

Interventions

USUAL CARE PROCEDURE

The treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients. Conventional medical care is based on hormonal, pharmacological and/or surgical treatment and is carried out on an individualized basis depending on the severity of the disease and the patient's needs, especially in matters of desire to become pregnant. Surgical treatment is carried out when pharmacological therapy (hormonal or anti-inflammatory) is ineffective or involves adverse events.

Control Group

PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM PROCEDURE

PAIN NEUROSCIENCE EDUCATION 1\. Introduction to the knowledge of pain in the XXI century. Pain as an alarm system. Types of pain. Differences between acute and chronic pain. 3. Chronic pain. Concepts of kinesiophobia, catastrophism and fear avoidance, self-determination and neuroplasticity. 4\. Main pain management tools based on scientific evidence. 5. . Transtheoretical model of change. Adherence to treatment, importance as a determinant in health. 6\. Messages for home. Strategies of active coping in the maintenance stage. THERAPEUTIC EXERCISE PROGRAM 10-min warm-up. Joint mobility exercises with dual task or gamification. 30-min main part. Sequence of balance work between strength and body flexibility dosed according to the specific needs of each participant. 10-min cool down including breathing exercises and motor imagery. Home exercise program: walking (150 minutes in total, 3 days alternating with the face-to-face sessions).

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (over 18 years of age) diagnosed with endometriosis.
• Women with the capacity to carry out a therapeutic program based on muscular exercise.
• Women with the capacity to understand the requirements of the study.

You may not qualify if:

• Women undergoing fertility and/or assisted reproduction treatment.
• Pregnant women.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universidad de Sevilla

Seville, Spain

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Endometriosis; Pain; Agnosia; Chronic Disease; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Disease Attributes; Pathologic Processes; Health Behavior; Behavior

Study Officials

• Carmen-María Suárez-Serrano

  Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.

  STUDY CHAIR

• José-Jesús Jiménez-Rejano

  Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.

  STUDY DIRECTOR

• Manuel Rebollo-Salas

  Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.

  STUDY DIRECTOR

• Inmaculada Villa-del-Pino

  Centro universitario San Isidoro, adscrito a Universidad Pablo de Olavide, Sevilla.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inmaculada Villa-del-Pino

CONTACT

+34679183871; inmvildel@alum.us.es

Manuel Rebollo-Salas

CONTACT

+34620399549; mrebollo@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available in the repository of the University of Seville once the research has been completed and the research report has been written.

Locations

ES (1)