NCT04485572

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,887

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

July 18, 2020

Last Update Submit

July 22, 2020

Conditions

Radiculopathy, Lumbosacral Region

Keywords

Lumbar radiculopathyNeurodynamic tension testsOrthopaedic tension testsLumbosacral radiculopathy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (4)

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)Diagnostic Test: MRI scan

Fajersztajn test (F) and Sicard test (S)

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

Diagnostic Test: Fajersztajn test (F) and Sicard test (S)Diagnostic Test: MRI scan

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: Passive Neck Flexion test (PNF)and Kernig test (K)Diagnostic Test: MRI scan

Slump test (ST) and Dejerine triad (DT)

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

Diagnostic Test: Slump test (ST) and Dejerine triad (DT)Diagnostic Test: MRI scan

Interventions

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)

Also known as: Index tests
Straight Leg Raise test and Bragard test
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)

Also known as: Index tests
Fajersztajn test (F) and Sicard test (S)
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)

Also known as: Index tests
Passive Neck Flexion test (PNF)and Kernig test (K)
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)

Also known as: Index tests
Slump test (ST) and Dejerine triad (DT)
MRI scanDIAGNOSTIC_TEST

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

Also known as: Gold Standard
Fajersztajn test (F) and Sicard test (S)Passive Neck Flexion test (PNF)and Kernig test (K)Slump test (ST) and Dejerine triad (DT)Straight Leg Raise test and Bragard test

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Clinical suspicion of lumbar or lumbosacral radiculopathy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 24, 2020

Study Start

July 1, 2014

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share