<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/NCT03801356</url>
  </required_header>
  <id_info>
    <org_study_id>18-718</org_study_id>
    <nct_id>NCT03801356</nct_id>
  </id_info>
  <brief_title>Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy</brief_title>
  <official_title>Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lumbar Spine Research Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      SNRB, as measured by the change in pain and objective functional ability, can solicit crucial&#xD;
      information regarding a patient's clinical picture and can predict a patient's outcome&#xD;
      post-surgery. By using the walk test as an objective functional assessment, the aim is to&#xD;
      better standardize the threshold for a positive response to SNRB.&#xD;
&#xD;
      In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with&#xD;
      lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as&#xD;
      outlined above, are multifactorial. The proposed study aims to minimize the known limitations&#xD;
      of these injections and prospectively define their positive and negative predictive value in&#xD;
      a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and&#xD;
      radiculopathy. The design will define a threshold of response utilizing both subjective and&#xD;
      objective measures and more accurately predict excellent results following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will identify the threshold response level that quantifies the predictive&#xD;
      value of diagnostic SNRBs in patients who present with lumbar foraminal stenosis and&#xD;
      radiculopathy. Specifically, the proposed study will address the question of whether there is&#xD;
      a degree or length of response to SNRB, which predicts an excellent surgical outcome. The&#xD;
      hypothesis is that diagnostic SNRBs, when performed correctly, are useful in localizing the&#xD;
      level of involvement in LSS and improve the accuracy and efficacy of surgical intervention.&#xD;
      Use of diagnostic SNRBs will thus be used to clarify the clinical picture, giving the surgeon&#xD;
      the information to make the right decision to operate or not, and, in the case of operation,&#xD;
      predicting the optimal level(s) for surgical intervention. In addition, the investigators&#xD;
      plan to identify and fully characterize a standard threshold level and time of nerve block&#xD;
      response that will optimize the accuracy, specificity, and sensitivity of SNRB in predicting&#xD;
      surgical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated early due to a number of concurrent issues: low enrollment, limited&#xD;
    data and COVID-19.&#xD;
  </why_stopped>
  <start_date type="Actual">August 23, 2018</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 5, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects will be enrolled into a single treatment participant pool.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) Leg Pain Score</measure>
    <time_frame>12-months</time_frame>
    <description>Aim: 0-2 point improvement&#xD;
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index Questionnaire (ODI)</measure>
    <time_frame>12-Months</time_frame>
    <description>Aim: 15-point improvement&#xD;
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.&#xD;
Structure / Content&#xD;
There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.&#xD;
Scoring Method&#xD;
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage.&#xD;
If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5&#xD;
Interpretation&#xD;
1.0%-20%: Minimal disability. Usually no treatment is indicated.&#xD;
2.20%-40% Moderate disability&#xD;
3.40%-60%: Severe disability&#xD;
4.60%-80%: Crippled&#xD;
5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D Questionnaire</measure>
    <time_frame>12-Months</time_frame>
    <description>Aim: Improvement in quality of life&#xD;
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Disability Questionnaire (PDQ)</measure>
    <time_frame>12-months</time_frame>
    <description>Aim: 26-point improvement&#xD;
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain.&#xD;
PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Back Pain</condition>
  <condition>Radiculopathy Lumbar</condition>
  <condition>Degenerative Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Selective Nerve Root Block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selective Nerve Root Block</intervention_name>
    <description>Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
    <arm_group_label>Selective Nerve Root Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-80&#xD;
&#xD;
          -  Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal&#xD;
             stenosis&#xD;
&#xD;
          -  Patients scheduled for an associated lumbar foraminotomy procedure&#xD;
&#xD;
          -  Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that&#xD;
             does not demonstrate a clear neurogenic source of their pain&#xD;
&#xD;
          -  Subjects must be available for the entire study duration (12 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if there is a clear correlation between imaging and&#xD;
             radiculopathy&#xD;
&#xD;
          -  Radiculopathy associated with trauma, tumor or infection. Non-radicular lower&#xD;
             extremity pain will also be excluded&#xD;
&#xD;
          -  Patients who cannot tolerate the SNRB without IV sedation&#xD;
&#xD;
          -  Surgery requiring multi-level decompression and/or fusion&#xD;
&#xD;
          -  Surgical indication for malignancy, injection or acute or emergency trauma&#xD;
&#xD;
          -  History of major surgery within 3 months prior to enrollment&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Presence of severe acute, chronic medical or psychiatric condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Steinmetz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Main Campus</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>February 8, 2023</results_first_submitted>
  <results_first_submitted_qc>June 29, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2023</results_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Michael Steinmetz, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>back pain</keyword>
  <keyword>lumbar spine pain</keyword>
  <keyword>nerve root block</keyword>
  <keyword>foraminotomy</keyword>
  <keyword>radiculopathy</keyword>
  <keyword>lumbar</keyword>
  <keyword>foraminal stenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Radiculopathy</mesh_term>
    <mesh_term>Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03801356/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Selective Nerve Root Block</title>
          <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Selective Nerve Root Block</title>
          <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS) Leg Pain Score</title>
        <description>Aim: 0-2 point improvement&#xD;
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.</description>
        <time_frame>12-months</time_frame>
        <population>Paired T-Test was conducted to compare the change in VAS score from Baseline Visit to 12 Month Visit. Although 11 patients were consented and completed a Baseline Visit, only 7 patients had a 12 Month Visit. Analysis included the 7/11 patients that completed a 12 Month Visit that captured the VAS Leg Pain Score.</population>
        <group_list>
          <group group_id="O1">
            <title>Selective Nerve Root Block</title>
            <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) Leg Pain Score</title>
          <description>Aim: 0-2 point improvement&#xD;
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.</description>
          <population>Paired T-Test was conducted to compare the change in VAS score from Baseline Visit to 12 Month Visit. Although 11 patients were consented and completed a Baseline Visit, only 7 patients had a 12 Month Visit. Analysis included the 7/11 patients that completed a 12 Month Visit that captured the VAS Leg Pain Score.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="3.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oswestry Disability Index Questionnaire (ODI)</title>
        <description>Aim: 15-point improvement&#xD;
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.&#xD;
Structure / Content&#xD;
There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.&#xD;
Scoring Method&#xD;
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage.&#xD;
If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5&#xD;
Interpretation&#xD;
1.0%-20%: Minimal disability. Usually no treatment is indicated.&#xD;
2.20%-40% Moderate disability&#xD;
3.40%-60%: Severe disability&#xD;
4.60%-80%: Crippled&#xD;
5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.</description>
        <time_frame>12-Months</time_frame>
        <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an ODI Questionnaire at 12 Month Visit. Due to no patient completing the ODI at 12 Month Visit, no analysis was completed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Selective Nerve Root Block</title>
            <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
          </group>
        </group_list>
        <measure>
          <title>Oswestry Disability Index Questionnaire (ODI)</title>
          <description>Aim: 15-point improvement&#xD;
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.&#xD;
Structure / Content&#xD;
There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.&#xD;
Scoring Method&#xD;
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage.&#xD;
If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5&#xD;
Interpretation&#xD;
1.0%-20%: Minimal disability. Usually no treatment is indicated.&#xD;
2.20%-40% Moderate disability&#xD;
3.40%-60%: Severe disability&#xD;
4.60%-80%: Crippled&#xD;
5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.</description>
          <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an ODI Questionnaire at 12 Month Visit. Due to no patient completing the ODI at 12 Month Visit, no analysis was completed for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EQ-5D Questionnaire</title>
        <description>Aim: Improvement in quality of life&#xD;
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.</description>
        <time_frame>12-Months</time_frame>
        <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an EQ-5D Questionnaire at 12 Month Visit. Due to no patient completing the EQ-5D at 12 Month Visit, no analysis was completed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Selective Nerve Root Block</title>
            <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
          </group>
        </group_list>
        <measure>
          <title>EQ-5D Questionnaire</title>
          <description>Aim: Improvement in quality of life&#xD;
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.</description>
          <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an EQ-5D Questionnaire at 12 Month Visit. Due to no patient completing the EQ-5D at 12 Month Visit, no analysis was completed for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Disability Questionnaire (PDQ)</title>
        <description>Aim: 26-point improvement&#xD;
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain.&#xD;
PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).</description>
        <time_frame>12-months</time_frame>
        <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed a PDQ Questionnaire at 12 Month Visit. Due to no patient completing the PDQ at 12 Month Visit, no analysis was completed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Selective Nerve Root Block</title>
            <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Disability Questionnaire (PDQ)</title>
          <description>Aim: 26-point improvement&#xD;
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain.&#xD;
PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).</description>
          <population>Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed a PDQ Questionnaire at 12 Month Visit. Due to no patient completing the PDQ at 12 Month Visit, no analysis was completed for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For subjects who completed study, adverse events were collected during time on study, an average of 12 months. Adverse events were not collected after study termination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Selective Nerve Root Block</title>
          <description>Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.&#xD;
Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early due to a number of concurrent issues. We found it difficult to enroll patients. Many of the patients were from out of region and/or had presented with a concurrent spinal injection. A new study injection could not be ordered due to the aforementioned issues. We attempted to mitigate, but it proved to be difficult.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Michael Steinmetz</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-445-5754</phone>
      <email>STEINMM@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801356
org study id: 18-718
nct id: NCT03801356
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial
      information regarding a patient's clinical picture and can predict a patient's outcome
      post-surgery. By using the walk test as an objective functional assessment, the aim is to
      better standardize the threshold for a positive response to SNRB.

      In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with
      lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as
      outlined above, are multifactorial. The proposed study aims to minimize the known limitations
      of these injections and prospectively define their positive and negative predictive value in
      a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and
      radiculopathy. The design will define a threshold of response utilizing both subjective and
      objective measures and more accurately predict excellent results following surgery.
The proposed study will identify the threshold response level that quantifies the predictive
      value of diagnostic SNRBs in patients who present with lumbar foraminal stenosis and
      radiculopathy. Specifically, the proposed study will address the question of whether there is
      a degree or length of response to SNRB, which predicts an excellent surgical outcome. The
      hypothesis is that diagnostic SNRBs, when performed correctly, are useful in localizing the
      level of involvement in LSS and improve the accuracy and efficacy of surgical intervention.
      Use of diagnostic SNRBs will thus be used to clarify the clinical picture, giving the surgeon
      the information to make the right decision to operate or not, and, in the case of operation,
      predicting the optimal level(s) for surgical intervention. In addition, the investigators
      plan to identify and fully characterize a standard threshold level and time of nerve block
      response that will optimize the accuracy, specificity, and sensitivity of SNRB in predicting
      surgical outcomes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects will be enrolled into a single treatment participant pool.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Visual Analog Scale (VAS) Leg Pain Score
time frame: 12-months
description: Aim: 0-2 point improvement
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.
measure: Oswestry Disability Index Questionnaire (ODI)
time frame: 12-Months
description: Aim: 15-point improvement
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Structure / Content
There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.
Scoring Method
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage.
If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5
Interpretation
1.0%-20%: Minimal disability. Usually no treatment is indicated.
2.20%-40% Moderate disability
3.40%-60%: Severe disability
4.60%-80%: Crippled
5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.
measure: EQ-5D Questionnaire
time frame: 12-Months
description: Aim: Improvement in quality of life
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
measure: Pain Disability Questionnaire (PDQ)
time frame: 12-months
description: Aim: 26-point improvement
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain.
PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).
arm group label: Selective Nerve Root Block
arm group type: Other
description: Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.
intervention type: Drug
intervention name: Selective Nerve Root Block
description: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
arm group label: Selective Nerve Root Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Michael Steinmetz, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Michael Steinmetz, MD
investigator title: Principal Investigator
mesh term: Spinal Stenosis
mesh term: Radiculopathy
mesh term: Back Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early due to a number of concurrent issues. We found it difficult to enroll patients. Many of the patients were from out of region and/or had presented with a concurrent spinal injection. A new study injection could not be ordered due to the aforementioned issues. We attempted to mitigate, but it proved to be difficult.
point of contact: 