Trials / Recruiting

RecruitingNCT06795243

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 32 (estimated)

Sponsor: University of Seville · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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).
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.

Timeline

Start date: 2025-05-01
Primary completion: 2026-05-31
Completion: 2026-07-01
First posted: 2025-01-28
Last updated: 2026-04-06

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06795243. Inclusion in this directory is not an endorsement.