Sensitivity and Specificity of Naadi (Siddha Pulse) Examination in Detecting Individuals with Cervical Spondylopathy attending National Institute of Siddha - A Blinded Diagnostic Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 402
- 试验地点
- 1
研究概览
简要总结
The ancient practice of pulse diagnosis has been in existence since antiquity and continues to be used in traditional medical systems such as Unani, Ayurveda, and Chinese medicine. Siddha medicine emphasizes Naadi examination (siddha pulse diagnosis) as a fundamental tool for disease detection and patient assessment.This study aims to determine the accuracy of Naadi in diagnosing cervical spondylopathy, potentially as cost-effective, non-invasive screening tool.
PRIMARY OBJECTIVE: To determine the sensitivity and specificity of Naadiin detecting the individuals with cervical spondylopathy.
SECONDARY OBJECTIVES:
To determine the positive predictive value (PPV) and negative predictive value (NPV) of the Naadi examinationin diagnosing cervical spondylopathy using examination tests and radiological imaging as the reference standard.
To determine the positive likelihood ratio and negative likelihood ratio of the Naadi examination in diagnosing cervical spondylopathy using examination tests and radiological imaging as the reference standard.
To determine the pre-test odds and post-test odds of cervical spondylopathy based on Naadiexamination findings, using clinical examination tests and radiological imaging as the reference standard.
To determine the diagnostic performance of Naadi examination using receiver operating characteristic (ROC) curve analysis and area under the curve (AUC).
To estimate difference inNaadi pattern in different types of cervical spondylopathy.
To estimate the yakkai ilakkanam for participants with cervical spondylopathy through validated questionnaires.
STUDY TYPE:
Observational study.
STUDY DESIGN:
A prospective blinded diagnostic study.
STUDY SETTING:
Outpatient and Inpatient department,
Ayothidoss Pandithar Hospital,
National Institute of Siddha,
Chennai-600047.
STUDY PERIOD:
18 months.
SAMPLE SIZE: 402
NUMBER OF CASES: 134
NUMBER OF CONTROLS: 268
**PRIMARY OUTCOME:**Sensitivity and Specificity of Naadi examination for the diagnosis of Cervical spondylopathywill be determined.SECONDARY OUTCOMES:
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Naadi examination for Cervical spondylopathy will be estimated.
Positive Likelihood Ratio and Negative Likelihood Ratio of Naadi examination will be calculated.
Pre-test odds and Post-test odds of Cervical spondylopathy based on Naadi examination will be evaluated.
Diagnostic performance of Naadi examination will be assessed using ROC curve analysis and Area Under the Curve (AUC).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who have neck pain and/or upper limb paraesthesia, numbness, or pain for at least 3 months.
- •Positive responses to any 2 of the following clinical tests: Spurling Test, Lhermitte’s test, Hoffman test, Upper Limb Tension Test, Cervical Distraction Test, and less than 60° of cervical rotation on the impaired side.
- •Participants with evidence of cervical spondylopathy or other structural abnormality on imaging studies.
排除标准
- •Participants presenting with cervical pain showing no evidence of cervical spondylopathy or other structural abnormality on imaging studies.
- •Vulnerable group (Pregnant and lactating women, children, geriatric and cognitive impaired patients).
研究者
Dr B Sanju Vikashini
National Institute of Siddha