Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,887
- 主要终点
- Sensitivity of the tests
研究概览
简要总结
The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.
详细描述
Lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient and it is considered as an important health problem. Therefore, its correct diagnosis is essential. The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.
This is an epidemiological study of randomized consecutive cases which was observational, descriptive, transversal, double blinded and followed the STARD (Standards for Reporting Diagnostic accuracy studies) declaration.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of lumbar or lumbosacral radiculopathy
排除标准
- •Healthy subjects or with a radiculopathy already diagnosed
- •subjects with Diabetes, alcoholism, HIV+, herpes zoster infection, cancer, multiple sclerosis, hereditary neuropathy or lumbar surgery
- •persons with pacemaker or stent
- •known pregnancy
- •persons that refused to participate in the study or undergo the MRI scan.
结局指标
主要结局
Sensitivity of the tests
时间窗: Through study completion, an average of 2 years
Is is an indicator of the internal validity of the test. The probability that a subject with lumbar or lumbosacral radiculopathy have a positive results in the diagnostic test. It is obtained with the statistical analysis
Specificity of the tests
时间窗: Through study completion, an average of 2 years
Is is an indicator of the internal validity of the test. Indicates the percentage of healthy subjects confirmed with a test with negative results. It is obtained with the statistical analysis
Kappa index (K)
时间窗: Through study completion, an average of 2 years
It is used to estimate the reliability or accuracy of the tests. The range of values are interpreted as follows: Poor, \< 0.20; weak, between 0.21 and 0.40; Moderate, between 0.41 and 0.60; Good, between 0.61 and 0.80; Very good, between 0.80 and 1
Likelihood Ratio (LR+ y LR-).
时间窗: Through study completion, an average of 2 years
Is is an indicator of the external validity of the test.The range of values and their impact on the clinical utility are: LR+: \> 10 great increase, excellent test; 5-10 moderate increase, good test; 2-5: small increase, bad test; \< 2: minor increase, useless test. LR-: 0.5-1 minor decrease, useless test; 0,5-0,2 small decrease, bad test; 0,1-0,2 moderate decrease, good test; \< 0,1 great decrease, execelent test
Positive and negative predictive values (PV+ and PV-)
时间窗: Through study completion, an average of 2 years
Is is an indicator of the internal validity of the test. The range of values are interpreted as: 0-10% null, 10-30% very low; 30-60% low; 60-70% low moderate; 70-80% high moderate; 80-90% high; 90-100% very high.
次要结局
未报告次要终点
研究者
Elisa María Garrido Ardila
Clinical Professor
University of Extremadura