Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

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

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.

Study Overview

• Status: Completed
• Conditions: Radiculopathy, Lumbosacral Region
• Intervention / Treatment: Diagnostic test: Straight Leg Raise test (SLR) and Bragard test (B); Diagnostic test: MRI scan; 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)

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 Type: Observational
• Enrollment (Actual): 1887

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population were all the patients referred to the Radiology Department of the 'Puerta del Mar University Hospital' in Cádiz (Spain) to undertake a MRI scan of the lumbar or lumbosacral spine

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Straight Leg Raise test and Bragard test; 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); 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); Other Names: Index tests; Diagnostic test: MRI scan; All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard; Other Names: Gold Standard
Fajersztajn test (F) and Sicard test (S); Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests	Diagnostic test: MRI scan; All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard; Other Names: Gold Standard; Diagnostic test: Fajersztajn test (F) and Sicard test (S); 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); Other Names: Index tests
Passive Neck Flexion test (PNF)and Kernig test (K); Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests	Diagnostic test: MRI scan; All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard; Other Names: Gold Standard; Diagnostic test: Passive Neck Flexion test (PNF)and Kernig test (K); 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); Other Names: Index tests
Slump test (ST) and Dejerine triad (DT); Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests	Diagnostic test: MRI scan; All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard; Other Names: Gold Standard; Diagnostic test: Slump test (ST) and Dejerine triad (DT); 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); Other Names: Index tests

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Extremadura
• Collaborators: University of Cadiz

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): August 30, 2016
• Study Completion (Actual): August 30, 2016

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Lumbar radiculopathy; Neurodynamic tension tests; Orthopaedic tension tests; Lumbosacral radiculopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 30/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No