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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04485572
Enrollment
1887
Registered
2020-07-24
Start date
2014-07-01
Completion date
2016-08-30
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiculopathy, Lumbosacral Region

Keywords

Lumbar radiculopathy, Neurodynamic tension tests, Orthopaedic tension tests, Lumbosacral radiculopathy

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.

Interventions

DIAGNOSTIC_TESTStraight 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)

DIAGNOSTIC_TESTFajersztajn 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)

DIAGNOSTIC_TESTPassive 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)

DIAGNOSTIC_TESTSlump 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)

DIAGNOSTIC_TESTMRI scan

All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard

Sponsors

University of Cadiz
CollaboratorOTHER
University of Extremadura
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of the testsThrough study completion, an average of 2 yearsIs 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 testsThrough study completion, an average of 2 yearsIs 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
Positive and negative predictive values (PV+ and PV-)Through study completion, an average of 2 yearsIs 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.
Likelihood Ratio (LR+ y LR-).Through study completion, an average of 2 yearsIs 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
Kappa index (K)Through study completion, an average of 2 yearsIt 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026