Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity

Conditions
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Radiculopathy, Lumbosacral Region

Intervention / Treatment
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* Diagnostic Test: Straight Leg Raise test (SLR) and Bragard test (B)
* Diagnostic Test: Fajersztajn test (F) and Sicard test (S)
* Diagnostic Test: Passive Neck Flexion test (PNF)and Kernig test (K)
* Diagnostic Test: Slump test (ST) and Dejerine triad (DT)
* Diagnostic Test: MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical suspicion of lumbar or lumbosacral radiculopathy Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Straight Leg Raise test and Bragard test<br>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests | Diagnostic Test: Straight Leg Raise test (SLR) and Bragard test (B)<br>* The following neurodynamic and/or orthopedic tension tests were done: the Straight Leg Raise test (SLR), the Bragard test (B) and another test which was the combined test of both (SLR+B)<br>* Other names: Index tests;Diagnostic Test: MRI scan<br>* All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard<br>* Other names: Gold Standard;|
| Fajersztajn test (F) and Sicard test (S)<br>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests | Diagnostic Test: Fajersztajn test (F) and Sicard test (S)<br>* The following neurodynamic and/or orthopedic tension tests were done: the Fajersztajn test (F), the Sicard test (S) and another test which was the combination of both (F+S)<br>* Other names: Index tests;Diagnostic Test: MRI scan<br>* All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard<br>* Other names: Gold Standard;|
| Passive Neck Flexion test (PNF)and Kernig test (K)<br>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests | Diagnostic Test: Passive Neck Flexion test (PNF)and Kernig test (K)<br>* The following neurodynamic and/or orthopedic tension tests were done: the Passive Neck Flexion test (PNF), the Kernig test (K) and another test which was the combination of both (PNF+K)<br>* Other names: Index tests;Diagnostic Test: MRI scan<br>* All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard<br>* Other names: Gold Standard;|
| Slump test (ST) and Dejerine triad (DT)<br>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests | Diagnostic Test: Slump test (ST) and Dejerine triad (DT)<br>* The following neurodynamic and/or orthopedic tension tests were done: the Slump test (ST), the Dejerine triad (DT) and another test which was the combination of both (ST+DT)<br>* Other names: Index tests;Diagnostic Test: MRI scan<br>* All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard<br>* Other names: Gold Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the tests | 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 | Through study completion, an average of 2 years | 
| Specificity of the tests | 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 | Through study completion, an average of 2 years | 
| Positive and negative predictive values (PV+ and PV-) | 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. | Through study completion, an average of 2 years | 
| Likelihood Ratio (LR+ y LR-). | 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 | Through study completion, an average of 2 years | 
| Kappa index (K) | 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 | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar radiculopathy, Neurodynamic tension tests, Orthopaedic tension tests, Lumbosacral radiculopathy