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Completed

NCT Number: NCT04485572

Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

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.

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Key information

Conditions

Radiculopathy, Lumbosacral Region Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Straight Leg Raise test (SLR) and Bragard test (B)

Diagnostic Test

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

Fajersztajn test (F) and Sicard test (S)

Diagnostic Test

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)

Diagnostic Test

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)

Diagnostic Test

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

MRI scan

Diagnostic Test

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

Other names: Gold Standard

Primary outcomes

  1. Sensitivity of the tests

    Time frame: 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

  2. Specificity of the tests

    Time frame: 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

  3. Positive and negative predictive values (PV+ and PV-)

    Time frame: 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.

  4. Likelihood Ratio (LR+ y LR-).

    Time frame: 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

  5. Kappa index (K)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Collaborators

  • University of Cadiz

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2020
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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