<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04485572</url>
  </required_header>
  <id_info>
    <org_study_id>30/14</org_study_id>
    <nct_id>NCT04485572</nct_id>
  </id_info>
  <brief_title>Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests</brief_title>
  <official_title>Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cadiz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Extremadura</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic&#xD;
      and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient&#xD;
      and it is considered as an important health problem. Therefore, its correct diagnosis is&#xD;
      essential. The objective of the present study is to analyse the diagnostic validity of 8&#xD;
      neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold&#xD;
      Standard.&#xD;
&#xD;
      This is an epidemiological study of randomized consecutive cases which was observational,&#xD;
      descriptive, transversal, double blinded and followed the STARD (Standards for Reporting&#xD;
      Diagnostic accuracy studies) declaration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">August 30, 2016</completion_date>
  <primary_completion_date type="Actual">August 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the tests</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of the tests</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and negative predictive values (PV+ and PV-)</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Likelihood Ratio (LR+ y LR-).</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Is is an indicator of the external validity of the test.The range of values and their impact on the clinical utility are: LR+: &gt; 10 great increase, excellent test; 5-10 moderate increase, good test; 2-5: small increase, bad test; &lt; 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; &lt; 0,1 great decrease, execelent test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kappa index (K)</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>It is used to estimate the reliability or accuracy of the tests. The range of values are interpreted as follows: Poor, &lt; 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</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1887</enrollment>
  <condition>Radiculopathy, Lumbosacral Region</condition>
  <arm_group>
    <arm_group_label>Straight Leg Raise test and Bragard test</arm_group_label>
    <description>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fajersztajn test (F) and Sicard test (S)</arm_group_label>
    <description>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive Neck Flexion test (PNF)and Kernig test (K)</arm_group_label>
    <description>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Slump test (ST) and Dejerine triad (DT)</arm_group_label>
    <description>Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Straight Leg Raise test (SLR) and Bragard test (B)</intervention_name>
    <description>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)</description>
    <arm_group_label>Straight Leg Raise test and Bragard test</arm_group_label>
    <other_name>Index tests</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fajersztajn test (F) and Sicard test (S)</intervention_name>
    <description>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)</description>
    <arm_group_label>Fajersztajn test (F) and Sicard test (S)</arm_group_label>
    <other_name>Index tests</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Passive Neck Flexion test (PNF)and Kernig test (K)</intervention_name>
    <description>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)</description>
    <arm_group_label>Passive Neck Flexion test (PNF)and Kernig test (K)</arm_group_label>
    <other_name>Index tests</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Slump test (ST) and Dejerine triad (DT)</intervention_name>
    <description>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)</description>
    <arm_group_label>Slump test (ST) and Dejerine triad (DT)</arm_group_label>
    <other_name>Index tests</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <description>All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard</description>
    <arm_group_label>Fajersztajn test (F) and Sicard test (S)</arm_group_label>
    <arm_group_label>Passive Neck Flexion test (PNF)and Kernig test (K)</arm_group_label>
    <arm_group_label>Slump test (ST) and Dejerine triad (DT)</arm_group_label>
    <arm_group_label>Straight Leg Raise test and Bragard test</arm_group_label>
    <other_name>Gold Standard</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population were all the patients referred to the Radiology Department of the&#xD;
        'Puerta del Mar University Hospital' in Cádiz (Spain) to undertake a MRI scan of the lumbar&#xD;
        or lumbosacral spine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical suspicion of lumbar or lumbosacral radiculopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects or with a radiculopathy already diagnosed&#xD;
&#xD;
          -  subjects with Diabetes, alcoholism, HIV+, herpes zoster infection, cancer, multiple&#xD;
             sclerosis, hereditary neuropathy or lumbar surgery&#xD;
&#xD;
          -  persons with pacemaker or stent&#xD;
&#xD;
          -  known pregnancy&#xD;
&#xD;
          -  persons that refused to participate in the study or undergo the MRI scan.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Extremadura</investigator_affiliation>
    <investigator_full_name>Elisa María Garrido Ardila</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Lumbar radiculopathy</keyword>
  <keyword>Neurodynamic tension tests</keyword>
  <keyword>Orthopaedic tension tests</keyword>
  <keyword>Lumbosacral radiculopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04485572
org study id: 30/14
nct id: NCT04485572
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Sensitivity of the tests
time frame: Through study completion, an average of 2 years
description: 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
measure: Specificity of the tests
time frame: Through study completion, an average of 2 years
description: 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
measure: Positive and negative predictive values (PV+ and PV-)
time frame: Through study completion, an average of 2 years
description: 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.
measure: Likelihood Ratio (LR+ y LR-).
time frame: Through study completion, an average of 2 years
description: 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
measure: Kappa index (K)
time frame: Through study completion, an average of 2 years
description: 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
arm group label: Straight Leg Raise test and Bragard test
description: Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
arm group label: Fajersztajn test (F) and Sicard test (S)
description: Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
arm group label: Passive Neck Flexion test (PNF)and Kernig test (K)
description: Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
arm group label: Slump test (ST) and Dejerine triad (DT)
description: Patients referred to the radiology department, allocated to undergo MRI scan and neurodynamic tension tests
intervention type: Diagnostic Test
intervention name: Straight Leg Raise test (SLR) and Bragard test (B)
description: 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)
arm group label: Straight Leg Raise test and Bragard test
other name: Index tests
intervention type: Diagnostic Test
intervention name: Fajersztajn test (F) and Sicard test (S)
description: 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)
arm group label: Fajersztajn test (F) and Sicard test (S)
other name: Index tests
intervention type: Diagnostic Test
intervention name: Passive Neck Flexion test (PNF)and Kernig test (K)
description: 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)
arm group label: Passive Neck Flexion test (PNF)and Kernig test (K)
other name: Index tests
intervention type: Diagnostic Test
intervention name: Slump test (ST) and Dejerine triad (DT)
description: 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)
arm group label: Slump test (ST) and Dejerine triad (DT)
other name: Index tests
intervention type: Diagnostic Test
intervention name: MRI scan
description: All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard
arm group label: Fajersztajn test (F) and Sicard test (S)
arm group label: Passive Neck Flexion test (PNF)and Kernig test (K)
arm group label: Slump test (ST) and Dejerine triad (DT)
arm group label: Straight Leg Raise test and Bragard test
other name: Gold Standard
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Extremadura
investigator full name: Elisa María Garrido Ardila
investigator title: Clinical Professor
mesh term: Radiculopathy
sharing ipd: No