Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests

NCT ID: NCT04485572

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1887 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2016-08-30

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.

Conditions

Radiculopathy, Lumbosacral Region

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Straight Leg Raise test and Bragard test

Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests

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

Intervention Type: 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)

MRI scan

Intervention Type: DIAGNOSTIC_TEST

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

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)

Intervention Type: 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)

MRI scan

Intervention Type: DIAGNOSTIC_TEST

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

Passive Neck Flexion test (PNF)and Kernig test (K)

Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests

Passive Neck Flexion test (PNF)and Kernig test (K)

Intervention Type: 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)

MRI scan

Intervention Type: DIAGNOSTIC_TEST

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

Slump test (ST) and Dejerine triad (DT)

Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests

Slump test (ST) and Dejerine triad (DT)

Intervention Type: 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)

MRI scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

MRI scan

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Index tests; Index tests; Index tests; Index tests; Gold Standard

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cadiz

OTHER

Sponsor Role: collaborator

University of Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Elisa María Garrido Ardila

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

30/14

Identifier Type: -

Identifier Source: org_study_id