Effect of a Therapeutic-educational Physiotherapy Program on Pain and the Physical-functional Sphere in Women With Endometriosis and Its Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Musculoskeletal pain - Pressure pain threshold
研究概览
简要总结
This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of endometriosis made by imaging techniques (MRI or ultrasound) or by surgery.
- •A period of 3 months or more since the last surgery if they have undergone surgery.
- •Who are receiving hormone treatment and have their disease under control.
- •Persistent pelvic pain for at least 3 months.
- •With pain and hypertonus in the pelvic musculature, myofascial syndrome, vestibulodynia or pudendal neuropathy.
- •Consent to participate in the study
- •Capable of carrying out the follow-up of the study until the final visit.
- •Who have audiovisual resources and the internet at their disposal.
排除标准
- •Women in the menopausal phase
- •Women undergoing fertility treatment or planning to undergo fertility treatment in the next 3 months.
- •Pregnant women.
- •Women undergoing physiotherapy treatment or who have undergone physiotherapy treatment in the last 3 months.
- •Having suffered a fracture in the last 3 months in the lower limb that limits their functional capacity.
- •Cognitive illness that prevents correct comprehension of the exercises.
- •Musculoskeletal pathology or neuropathy in acute phase.
- •Having suffered or suffering from a neoplastic disease.
- •Untreated endometriosis
- •Acquired genital abnormalities of the pelvis or pelvic floor.
- •Women in a situation of litigation or economic compensation, or pending the granting of a degree of disability.
- •Severe mental illness (schizophrenia, borderline personality disorder, etc.)
研究组 & 干预措施
Experimental
They will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program,
干预措施: therapeutic-educational physiotherapy and pain education program (Other)
Control
They will receive the pain education program.
干预措施: pain education program (Other)
结局指标
主要结局
Musculoskeletal pain - Pressure pain threshold
时间窗: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Pressure pain threshold measured in rectus abdominis and lumbar muscles
Musculoskeletal pain - quantitative Sensory Testing
时间窗: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quantitative sensory testing is a non-invasive technique used to assess and quantify sensory functions by determining sensation and pain thresholds using pressure.
Musculoskeletal pain - pain drawing
时间窗: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Identification of pain areas through a pain map: this consists of a human figure on a two-dimensional plane on which the patient can express the representation of the pain areas on a schematic of the body surface.
Musculoskeletal pain - Central Sensitisation Inventory
时间窗: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Central Sensitisation Inventory: is a self-report instrument that indirectly assesses somatic and emotional symptoms that have been found to be associated with Central Sensitisation.
次要结局
- Physical-Funcionality - functional performance(3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Lumbar spine flexibility(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Catastrophyzing(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Kinesophobia(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Quality of Life - Stress(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Patient's satisfaction(assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Quality of Life - Endometriosis(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Hand grip Strength(3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Motor control(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality- Pelvic floor Dynamometry(3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Physical-Funcionality - Body composition(3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Quality of Life - Gastrointestinal(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Biomarkers - Inflamation(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- APP usability(assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Quality of Life - Sexual Function(assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Patient's perception of change(assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
- Adherence to treatment(assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention))
研究者
Laura Fuentes Aparicio
Doctor
University of Valencia