Clinical trial NCT06795243: Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.
Official title: Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Endometriosis Related Pain
Endometriosis, Pain
Endometriosis-related 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
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
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Self-report Pain magnitude
timeFrame: 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
measure: Treatment Compliance
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Treatment adherence (Maintenance of the therapeutic exercise program at home )
timeFrame: From the end of the intervention at 8 weeks (starting at week 9) to the end of treatment at 32 weeks
measure: Changes from Self-report pain catastrophizing
timeFrame: 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
measure: Change from Self-report specific quality of life
timeFrame: 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
measure: Changes in self-reported general quality of life
timeFrame: 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:
measure: Exercise-related adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Universidad de Sevilla
Study officials:
affiliation: Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
name: Carmen-María Suárez-Serrano
role: STUDY_CHAIR
affiliation: Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
name: José-Jesús Jiménez-Rejano
role: STUDY_DIRECTOR
affiliation: Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
name: Manuel Rebollo-Salas
role: STUDY_DIRECTOR
affiliation: Centro universitario San Isidoro, adscrito a Universidad Pablo de Olavide, Sevilla.
name: Inmaculada Villa-del-Pino
role: PRINCIPAL_INVESTIGATOR
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