Radiculopathy, Lumbosacral RegionNCT04485572
Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests
An observational study of Radiculopathy, Lumbosacral Region, run by University of Extremadura.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiculopathy, Lumbosacral Region
- What is being tested?
- Straight Leg Raise test (SLR) and Bragard test (B), Fajersztajn test (F) and Sicard test (S) and Passive Neck Flexion test (PNF)and Kernig test (K)
- How many people
- 1,887 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 30 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Clinical suspicion of lumbar or lumbosacral radiculopathy
Who cannot join
- 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.
About this study
Official title: Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity
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.
Read the 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
- Being tested
- Straight Leg Raise test (SLR) and Bragard test (B), Fajersztajn test (F) and Sicard test (S), Passive Neck Flexion test (PNF)and Kernig test (K), Slump test (ST) and Dejerine triad (DT), MRI scan
- Keywords
- Lumbar radiculopathy, Neurodynamic tension tests, Orthopaedic tension tests, Lumbosacral radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight Leg Raise test (SLR) and Bragard test (B)Diagnostic test
Also called Index tests
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)Diagnostic test
Also called Index tests
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)Diagnostic test
Also called Index tests
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)Diagnostic test
Also called Index tests
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 scanDiagnostic test
Also called Gold Standard
All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard
| Study group | Role | What they receive |
|---|---|---|
| Straight Leg Raise test and Bragard test | Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Slump test (ST) and Dejerine triad (DT); Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jul 2014
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiculopathy, Lumbosacral RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,887 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cadiz
- Responsible party
- Principal investigator, Elisa María Garrido Ardila, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485572
- Sponsor's protocol ID
- 30/14
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity
- ClinicalTrials.gov ID
- NCT04485572
- Acronym / sponsor ID
- 30/14
- Conditions
- Radiculopathy, Lumbosacral Region
- Keywords
- Lumbar radiculopathy, Neurodynamic tension tests, Orthopaedic tension tests, Lumbosacral radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,887 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Collaborators
- University of Cadiz
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Straight Leg Raise test and Bragard test | – | Diagnostic Test: Straight Leg Raise test (SLR) and Bragard test (B), Diagnostic Test: MRI scanPatients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests |
| Fajersztajn test (F) and Sicard test (S) | – | Diagnostic Test: Fajersztajn test (F) and Sicard test (S), Diagnostic Test: MRI scanPatients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests |
| Passive Neck Flexion test (PNF)and Kernig test (K) | – | Diagnostic Test: Passive Neck Flexion test (PNF)and Kernig test (K), Diagnostic Test: MRI scanPatients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests |
| Slump test (ST) and Dejerine triad (DT) | – | Diagnostic Test: Slump test (ST) and Dejerine triad (DT), Diagnostic Test: MRI scanPatients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Clinical suspicion of lumbar or lumbosacral radiculopathy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straight Leg Raise test (SLR) and Bragard test (B)Also: Index testsThe 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 test | Straight Leg Raise test and Bragard test |
| Fajersztajn test (F) and Sicard test (S)Also: Index testsThe 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 test | Fajersztajn test (F) and Sicard test (S) |
| Passive Neck Flexion test (PNF)and Kernig test (K)Also: Index testsThe 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 test | Passive Neck Flexion test (PNF)and Kernig test (K) |
| Slump test (ST) and Dejerine triad (DT)Also: Index testsThe 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 test | Slump test (ST) and Dejerine triad (DT) |
| MRI scanAlso: Gold StandardAll participants will undergo a MRI scan to compare results between the index tests and the Gold Standard | Diagnostic test | 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 |
Primary outcome
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
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiculopathy, Lumbosacral Region, run by University of Extremadura.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the tests (time frame: Through study completion, an average of 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.