Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

Radiculopathy, Lumbosacral Region Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485572
• Other study ID #: 30/14
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: August 30, 2016

Study information

• Verified date: July 2020
• Source: University of Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1887
• Est. completion date: August 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiculopathy
• Radiculopathy, Lumbosacral Region

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Extremadura	University of Cadiz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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