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

March 30, 2026 updated by: Manuel Rebollo Salas, University of Seville
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a chronic and inflammatory gynecological condition characterized by the growth of endometrial- like tissue within and outside the pelvic cavity (uterus).

With current means and diagnostic systems, a prevalence of 10% is estimated, although the evidence warns that with the improvement of early diagnosis, these figures will be much higher in the future. One of the main problems with endometriosis is the late diagnosis, which takes an average of seven years. Added to this is the fact that until a definitive diagnosis, patients live in the adolescent stage with symptoms (around 50% with severe pelvic pain) that cause disability and changes in activity and participation in daily life.

At the social level, endometriosis patients are known to have limitations in academic and work activities, as well as in social participation. All of this causes high economic costs.

Chronic pelvic pain can cause the phenomenon of central nervous system sensitization in which pain processing is altered. Pain catastrophizing significantly affects pain disability and vice versa in endometriosis.

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 treatment and the patient's needs.

The multidisciplinary approach to endometriosis has gained relevance in recent decades and has been considered by leaders in the clinical and research sectors. Within the multidisciplinary team, physiotherapy has gained relevance in recent decades.

The multimodal approach of physiotherapy is the one that the Clinical Practice Guidelines and national and international documents demand with greater relevance. Therapeutic exercise based on the work of the abdominal stabilizing musculature and motor control appears to be effective in the treatment of nonspecific low back pain and in endometriosis-related pain. But there is no 'gold standard' in terms of dosage, considering the individualization of treatments.

In the biopsychosocial care paradigm, and specifically in the approach to pathologies with primary chronic pain, patients tend to be motivated and accompanied toward self-determination to achieve adherence to treatment through health education strategies, adequate information, and personalized and goal-oriented multimodal treatment.

However, today, nonadherence is positioned as a global problem, which is growing as the burden of chronicity of pathologies increases, influencing health outcomes and long-term healthcare costs.

Due to symptomatology especially related to chronic pain in endometriosis and in the context of the biopsychosocial paradigm demanded by the scientific community, the investigators consider pertinent the study of catastrophization and its relationship with quality of life and, therefore, disability, and an intervention that addresses in a multimodal way the physiotherapy treatment for endometriosis.

It is recognized that physiotherapeutic interventions based on therapeutic exercise programs, both individual and group, are most effective when tailored to the needs of everyone. Part of this customization should focus on the barriers that each patient recognizes to treatment adherence.

For this reason, the investigators found that studies that support further research to increase the basic understanding of the factors that act as a barrier to adherence in physical therapy treatments could facilitate the development of strategies to overcome nonadherence. And if the investigators follow international recommendations, these systems should address adherence and compliance to treatment from a multidimensional perspective.

Therefore, the investigators believe that measuring compliance and adherence to treatment in this way in patients with endometriosis would allow to know whether adherence to the proposed exercise programs in the target population and their effectiveness are really related or not to the adherence rates to treatment as suggested in recent publications.

In view of the above, this project aims to examine the relationship between the efficacy of physical therapy treatment in patients diagnosed with endometriosis measured in clinical and quality of life terms with short-term compliance and short- and medium-term adherence rates.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Manuel Rebollo-Salas
  • Phone Number: +34620399549
  • Email: mrebollo@us.es

Study Locations

  • Spain
      • Seville, Spain
        • Recruiting
        • Universidad de Sevilla
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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

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).
Active Comparator: Control Group
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Self-report Pain magnitude
Time Frame: 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
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
Time Frame: From enrollment to the end of treatment at 8 weeks
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
Changes from Self-report pain catastrophizing
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Treatment adherence (Maintenance of the therapeutic exercise program at home )
Time Frame: From the end of the intervention at 8 weeks (starting at week 9) to the end of treatment at 32 weeks.

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 2 times a week). Each patient will complete the VAS scale monthly. Participants with a score equal to or greater than 8 points out of 10 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise-related adverse events
Time Frame: 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
Possible occurrence of pain, frequency of flares and fatigue, measured qualitatively in narrative text through patient diary.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Study Chair: Carmen-María Suárez-Serrano, Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
  • Study Director: 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.
  • Principal Investigator: Inmaculada Villa-del-Pino, Centro universitario San Isidoro, adscrito a Universidad Pablo de Olavide, Sevilla.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SICEIA 2024-146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD.

The data to be provided will refer to all the variables of the study: independent, dependent and control variables.

Dependent (Catastrophic thoughts about pain, magnitude of chronic pain, general quality of life, specific quality of life, adverse events related to exercise ( pain, frequency of flares and fatigue), adherence and compliance to treatment Control variables:

  • Age (years).
  • Height: measured in centimeters.
  • Weight: measured in kilograms.
  • BMI: (kg/m2).
  • Work and/or academic activity: measured according to whether the person works, studies or both at the same time.
  • Academic level: measured according to whether the person has compulsory or higher education.
  • Stage of pathology: measured in stages according to the American Society for Reproductive Medicine.

All this will be carried out preserving the confidentiality of the data of the study participants according to the rules of the Ethics Committee of the University of Seville.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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