Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Treatment adherence (Maintenance of the therapeutic exercise program at home )
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Women undergoing fertility and/or assisted reproduction treatment.
- •Pregnant women.
研究组 & 干预措施
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.
干预措施: PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM (Procedure)
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.
干预措施: USUAL CARE (Procedure)
结局指标
主要结局
Treatment adherence (Maintenance of the therapeutic exercise program at home )
时间窗: 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.
Change from Self-report Pain magnitude
时间窗: 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.
Treatment Compliance
时间窗: 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.
Changes from Self-report pain catastrophizing
时间窗: 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.
Change from Self-report specific quality of life
时间窗: 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.
Changes in self-reported general quality of life
时间窗: 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.
次要结局
- 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)
研究者
Manuel Rebollo Salas
Principal investigator
University of Seville