Neuroimaging of Patients With Severe Knee Osteoarthrosis - Evaluation of Cerebral Volumetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Cerebral Volumetry Comparison
研究概览
简要总结
Due to scarce published articles about this subject, the researchers aim to study the volume measurements of the brain cortex of patients with primary severe knee osteoarthrosis and those with chronic knee pain compared to healthy and non-symptomatic volunteers, correlating the neuroimaging of cerebral volumetry with pain intensity, pain duration, knee function and pressure pain threshold.
详细描述
The protocol was designed to include 31 patients in each observational arm, either patients with severe knee osteoarthrosis and chronic knee pain or healthy and non-symptomatic volunteers.
The researchers performed anamnesis to collect clinical and demographic information, the intensity of pain was assessed by the self-rated Visual Analogue Scale (VAS), the pressure pain threshold was evaluated with an algometer, the knee function was assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and the images were collected with the use of the Magnetic Resonance.
Covariates, such as age, gender, Body Mass Index (BMI) and comorbidities as diabetes, cardiac diseases, pulmonary diseases, endocrine diseases and the practice of physical activities were also collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 60 years old;
- •Both genders;
- •Clinical diagnosis of knee osteoarthrosis;
- •Self-rated VAS moderate to severe (VAS > 4);
- •Pain duration longer than 3 months prior to the evaluation;
- •Signed Informed Consent;
- •Light physical activity practice or sedentary (healthy volunteers only).
排除标准
- •Presence of psychiatric disorders;
- •Presence of fibromyalgia;
- •Presence of rheumatologic diseases;
- •Presence of previous knee surgery;
- •Presence of clinical symptoms (healthy volunteers only);
- •Presence of knee pain on the previous 6 months (healthy volunteers only);
- •History of neoplasia.
结局指标
主要结局
Cerebral Volumetry Comparison
时间窗: Baseline at time of evaluation.
Brain Magnetic Resonance on axial Fluid Attenuated Inversion Recovery (FLAIR) and axial volume comparison between the healthy and the Knee Osteoarthrosis Group.
次要结局
- Pressure Pain Threshold Comparison(Baseline at time of evaluation.)
- VAS Comparison(Baseline at time of evaluation.)
研究者
Marta Imamura
Coordinator of the Clinical Research Site of Institute of Physical and Rehabilitation Medicine of HC FMUSP
University of Sao Paulo