Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

Completed

• Conditions: Radiculopathy, Lumbosacral Region
• Interventions: Diagnostic Test: Slump test (ST) and Dejerine triad (DT); 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: MRI scan

• Registration Number: NCT04485572
• Lead Sponsor: University of Extremadura

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2016-08-30
• Study Completion: 2016-08-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-22
• Last Update Submitted: 2020-07-22
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1887

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Passive Neck Flexion test (PNF)and Kernig test (K)	MRI scan	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Slump test (ST) and Dejerine triad (DT)	Slump test (ST) and Dejerine triad (DT)	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Straight Leg Raise test and Bragard test	Straight Leg Raise test (SLR) and Bragard test (B)	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Fajersztajn test (F) and Sicard test (S)	Fajersztajn test (F) and Sicard test (S)	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Fajersztajn test (F) and Sicard test (S)	MRI scan	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Straight Leg Raise test and Bragard test	MRI scan	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Passive Neck Flexion test (PNF)and Kernig test (K)	Passive Neck Flexion test (PNF)and Kernig test (K)	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
Slump test (ST) and Dejerine triad (DT)	MRI scan	Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests

Primary Outcome Measures

Name	Time	Method
Sensitivity of the tests	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	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)	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-).	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-)	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.