<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/NCT02226159</url>
  </required_header>
  <id_info>
    <org_study_id>9086-14019</org_study_id>
    <nct_id>NCT02226159</nct_id>
  </id_info>
  <brief_title>Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain</brief_title>
  <acronym>SPIES</acronym>
  <official_title>Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoCarolina Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charlotte Surgery Center an affiate of SCA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>OrthoCarolina Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cervical radicular pain is a common cause of disability and pain in the upper extremity and&#xD;
      neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and&#xD;
      includes relative rest, use of anti-inflammatory and analgesic medication, as well as&#xD;
      physical therapy and home exercise. For patients who have persistent and significant&#xD;
      symptoms, interventional pain management and surgical management are considered. Cervical&#xD;
      epidural injections are the mainstay of the interventional, non-surgical modalities. They can&#xD;
      be considered to provide short and long-term relief when disc herniation, foraminal stenosis&#xD;
      or central canal stenosis pathology is identified. We are not aware of any published&#xD;
      prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of&#xD;
      cervical transforaminal epidural steroid injections. However, the North American Spine&#xD;
      Society (NASS) Review and Recommendation Statement states that based on the literature and&#xD;
      expert opinion, a minimum of one or two cervical epidural steroid injections would be very&#xD;
      appropriate in the treatment of a specific episode of cervical radicular pain.&#xD;
&#xD;
      The purpose of this study is to determine the effectiveness of cervical transforaminal&#xD;
      epidural steroid injections in decreasing the need for an operation in patients with cervical&#xD;
      radicular pain, otherwise considered to be operative candidates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical radicular pain is a common cause of disability and pain in the upper extremity and&#xD;
      neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and&#xD;
      includes relative rest, use of anti-inflammatory and analgesic medication, as well as&#xD;
      physical therapy and home exercise. For patients who have persistent and significant&#xD;
      symptoms, interventional pain management and surgical management are considered. Cervical&#xD;
      epidural injections are the mainstay of the interventional, non-surgical modalities. They can&#xD;
      be considered to provide short and long-term relief when disc herniation, foraminal stenosis&#xD;
      or central canal stenosis pathology is identified.&#xD;
&#xD;
      Cervical epidural injections can be performed by two different approaches, transforaminal and&#xD;
      interlaminar. Transforaminal epidural injections allow delivery of medication to the ventral&#xD;
      epidural space, while the interlaminar approach reaches the ventral epidural space in only&#xD;
      28% of injections (2-4). The results of cervical epidural injections remain controversial and&#xD;
      their efficacy in decreasing the need for surgery in patients who would otherwise be&#xD;
      operative candidates has not been thoroughly investigated. Studies have been limited by small&#xD;
      sample sizes, lack of control groups, and lack of randomization. Kolstad et al reported that&#xD;
      23% (5/21) of patients waiting for cervical disc surgery cancelled surgery when assessed at&#xD;
      four months after having a series of two cervical epidural injections (6). Lin et al reported&#xD;
      that 63% (44/70) of patients who were deemed to be surgical candidates were able to avoid&#xD;
      surgery with an average of 13-month follow up (7). Lee et al reported that over 80% of 98&#xD;
      patients evaluated with cervical radiculopathy were able to avoid surgery with a 2-year&#xD;
      follow-up (8). Anderberg et al reported that there was no short-term difference in symptoms&#xD;
      of cervical radiculopathy between patients who received transforaminal injections of steroid&#xD;
      with local anesthetic versus saline with local anesthetic. However, this study did not&#xD;
      evaluate whether the injections were successful in the patients avoiding surgery (11).&#xD;
&#xD;
      In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that steroid&#xD;
      injections obviated the need for surgery in patients with lumbar radiculopathy. Moreover,&#xD;
      Reiw et al showed that steroid combined with local anesthetic was more effective than local&#xD;
      anesthetic alone in a prospective, randomized, controlled, double-blinded study (9). Riew et&#xD;
      al later studied the efficacy of cervical transforaminal epidural injections in the same&#xD;
      fashion, but the findings were not statistically significant (p&lt;0.35) and not published (10).&#xD;
&#xD;
      We are not aware of any published prospective, randomized, controlled, double-blinded studies&#xD;
      demonstrating the efficacy of cervical transforaminal epidural steroid injections. However,&#xD;
      the North American Spine Society (NASS) Review and Recommendation Statement states that based&#xD;
      on the literature and expert opinion, a minimum of one or two cervical epidural steroid&#xD;
      injections would be very appropriate in the treatment of a specific episode of cervical&#xD;
      radicular pain. This literature also suggests that a maximum of four injections can be used&#xD;
      within six months, assuming there was a positive response and improvement seen with the&#xD;
      previous injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Avoidance of Neck Surgery</measure>
    <time_frame>12 months after the first injection</time_frame>
    <description>The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>4 weeks</time_frame>
    <description>Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Scre</measure>
    <time_frame>4 weeks</time_frame>
    <description>Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>6 Months</time_frame>
    <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>12 Months</time_frame>
    <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Score</measure>
    <time_frame>6 Months</time_frame>
    <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Score</measure>
    <time_frame>12 Months</time_frame>
    <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Pain, Radiating</condition>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine with Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <arm_group_label>Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine with Dexamethasone</intervention_name>
    <arm_group_label>Lidocaine with Dexamethasone</arm_group_label>
    <other_name>Lidocaine</other_name>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have cervical radicular pain without significant neurologic deficit&#xD;
             (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT&#xD;
             findings of neural compression (neural compression is defined as disc herniation or&#xD;
             central or foraminal spinal stenosis),&#xD;
&#xD;
          -  Failed 6 weeks of conservative treatment (conservative treatment is defined as&#xD;
             relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or&#xD;
             analgesic medications),&#xD;
&#xD;
          -  Deemed to be good operative candidates by spine surgeons (patients with MRI/CT&#xD;
             findings of neural compression with concordant symptoms) and had agreed to possible&#xD;
             operative intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of&#xD;
&#xD;
               1. acute trauma,&#xD;
&#xD;
               2. diabetes (type I or type II),&#xD;
&#xD;
               3. active infection&#xD;
&#xD;
          -  Active progressive neurological deficit (neurologic is deficit defined as manual&#xD;
             muscle testing less than 3/5),&#xD;
&#xD;
          -  Medical condition that may affect the cervical spine neurological exam and/or pain&#xD;
             assessment (e.g. peripheral neuropathy),&#xD;
&#xD;
          -  Bilateral disease,&#xD;
&#xD;
          -  More than one cervical level requiring injection,&#xD;
&#xD;
          -  Bleeding disorders or other medical contraindications to the injection procedure,&#xD;
&#xD;
          -  Absence of substantial radicular pain (radicular pain is defined as arm pain greater&#xD;
             than neck pain),&#xD;
&#xD;
          -  Involvement in workers' compensation claim, or any litigation related to neck injury.&#xD;
&#xD;
          -  Patients who are pregnant, or who plan to become pregnant in the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sam Bhagia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OrthoCarolina Research Institute, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OrthoCarolina</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.</citation>
    <PMID>8186959</PMID>
  </reference>
  <reference>
    <citation>Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011.</citation>
    <PMID>11880836</PMID>
  </reference>
  <reference>
    <citation>Strub WM, Brown TA, Ying J, Hoffmann M, Ernst RJ, Bulas RV. Translaminar cervical epidural steroid injection: short-term results and factors influencing outcome. J Vasc Interv Radiol. 2007 Sep;18(9):1151-5. doi: 10.1016/j.jvir.2007.06.011.</citation>
    <PMID>17804778</PMID>
  </reference>
  <reference>
    <citation>Lieberman R, Dreyfuss P, Baker R. Fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 Oct;84(10):1568-9; author reply 1569. doi: 10.1016/j.apmr.2003.08.072. No abstract available.</citation>
    <PMID>14594016</PMID>
  </reference>
  <reference>
    <citation>Manchikanti L, Falco FJ, Diwan S, Hirsch JA, Smith HS. Cervical radicular pain: the role of interlaminar and transforaminal epidural injections. Curr Pain Headache Rep. 2014 Jan;18(1):389. doi: 10.1007/s11916-013-0389-9.</citation>
    <PMID>24338702</PMID>
  </reference>
  <reference>
    <citation>Kolstad F, Leivseth G, Nygaard OP. Transforaminal steroid injections in the treatment of cervical radiculopathy. A prospective outcome study. Acta Neurochir (Wien). 2005 Oct;147(10):1065-70; discussion 1070. doi: 10.1007/s00701-005-0542-2. Epub 2005 Jun 9.</citation>
    <PMID>15924210</PMID>
  </reference>
  <reference>
    <citation>Lin EL, Lieu V, Halevi L, Shamie AN, Wang JC. Cervical epidural steroid injections for symptomatic disc herniations. J Spinal Disord Tech. 2006 May;19(3):183-6. doi: 10.1097/01.bsd.0000190558.13248.e1.</citation>
    <PMID>16770215</PMID>
  </reference>
  <reference>
    <citation>Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.</citation>
    <PMID>22024908</PMID>
  </reference>
  <reference>
    <citation>Riew KD, Yin Y, Gilula L, Bridwell KH, Lenke LG, Lauryssen C, Goette K. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am. 2000 Nov;82(11):1589-93. doi: 10.2106/00004623-200011000-00012.</citation>
    <PMID>11097449</PMID>
  </reference>
  <reference>
    <citation>Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. Transforaminal steroid injections for the treatment of cervical radiculopathy: a prospective and randomised study. Eur Spine J. 2007 Mar;16(3):321-8. doi: 10.1007/s00586-006-0142-8. Epub 2006 Jul 12.</citation>
    <PMID>16835737</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>September 1, 2020</results_first_submitted>
  <results_first_submitted_qc>September 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 20, 2020</results_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical</keyword>
  <keyword>radicular pain</keyword>
  <keyword>transforaminal epidural steroid injections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <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>April 17, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT02226159/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lidocaine</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
        </group>
        <group group_id="P2">
          <title>Lidocaine With Dexamethasone</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lidocaine</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
        </group>
        <group group_id="B2">
          <title>Lidocaine With Dexamethasone</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" lower_limit="44" upper_limit="58"/>
                    <measurement group_id="B2" value="53.5" lower_limit="46" upper_limit="62"/>
                    <measurement group_id="B3" value="52" lower_limit="45" upper_limit="60"/>
                  </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="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </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="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="27"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Verbal Numeric Pain Score</title>
          <description>On a scale of 1-10 with 10 indicating the greatest among of pain</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5" lower_limit="5" upper_limit="7"/>
                    <measurement group_id="B2" value="7" lower_limit="5" upper_limit="8"/>
                    <measurement group_id="B3" value="6.5" lower_limit="5" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Neck Disability Index</title>
          <description>Scored from 0-50, with 50 indicating the greatest amount of disability</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" lower_limit="26" upper_limit="40"/>
                    <measurement group_id="B2" value="35" lower_limit="24" upper_limit="48"/>
                    <measurement group_id="B3" value="34" lower_limit="26" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Scored from 0-10 with 10 indicating the greatest among of patient satisfaction</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="B2" value="3" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="B3" value="3.5" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Avoidance of Neck Surgery</title>
        <description>The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.</description>
        <time_frame>12 months after the first injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Avoidance of Neck Surgery</title>
          <description>The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No(had surgery)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes (Did not have surgery)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability</title>
        <description>Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Disability</title>
          <description>Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
          <units>units 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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" spread="14.1"/>
                    <measurement group_id="O2" value="22.8" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Pain Scre</title>
        <description>Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Scre</title>
          <description>Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.8"/>
                    <measurement group_id="O2" value="3.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" spread="2.8"/>
                    <measurement group_id="O2" value="6.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability</title>
        <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Disability</title>
          <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
          <units>units 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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" spread="15.3"/>
                    <measurement group_id="O2" value="18.3" spread="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability</title>
        <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
        <time_frame>6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Disability</title>
          <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
          <units>units 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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="14.0"/>
                    <measurement group_id="O2" value="16.3" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability</title>
        <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Disability</title>
          <description>Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).</description>
          <units>units 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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" spread="14.4"/>
                    <measurement group_id="O2" value="15.4" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Pain Score</title>
        <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Score</title>
          <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.4"/>
                    <measurement group_id="O2" value="3.4" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Pain Score</title>
        <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
        <time_frame>6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Score</title>
          <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.4"/>
                    <measurement group_id="O2" value="2.2" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Pain Score</title>
        <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Score</title>
          <description>Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="2.8"/>
                    <measurement group_id="O2" value="3.2" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="2.4"/>
                    <measurement group_id="O2" value="6.6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="2.4"/>
                    <measurement group_id="O2" value="7.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lidocaine</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Lidocaine With Dexamethasone</title>
            <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction</description>
          <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="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="2.8"/>
                    <measurement group_id="O2" value="6.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lidocaine</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline&#xD;
Lidocaine</description>
        </group>
        <group group_id="E2">
          <title>Lidocaine With Dexamethasone</title>
          <description>Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)&#xD;
Lidocaine with Dexamethasone</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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness and tingling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Flu-like symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>hot/flushed feeling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pain at injection site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Increased arm/neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>shortness of breath</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Susan Odum</name_or_title>
      <organization>OrthoCarolina Research Institute</organization>
      <phone>7049457710</phone>
      <email>susan.odum@orthocarolina.com</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/NCT02226159
org study id: 9086-14019
nct id: NCT02226159
lead sponsor: 
collaborator: 
has dmc: Yes
Cervical radicular pain is a common cause of disability and pain in the upper extremity and
      neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
      includes relative rest, use of anti-inflammatory and analgesic medication, as well as
      physical therapy and home exercise. For patients who have persistent and significant
      symptoms, interventional pain management and surgical management are considered. Cervical
      epidural injections are the mainstay of the interventional, non-surgical modalities. They can
      be considered to provide short and long-term relief when disc herniation, foraminal stenosis
      or central canal stenosis pathology is identified. We are not aware of any published
      prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of
      cervical transforaminal epidural steroid injections. However, the North American Spine
      Society (NASS) Review and Recommendation Statement states that based on the literature and
      expert opinion, a minimum of one or two cervical epidural steroid injections would be very
      appropriate in the treatment of a specific episode of cervical radicular pain.

      The purpose of this study is to determine the effectiveness of cervical transforaminal
      epidural steroid injections in decreasing the need for an operation in patients with cervical
      radicular pain, otherwise considered to be operative candidates.
Cervical radicular pain is a common cause of disability and pain in the upper extremity and
      neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
      includes relative rest, use of anti-inflammatory and analgesic medication, as well as
      physical therapy and home exercise. For patients who have persistent and significant
      symptoms, interventional pain management and surgical management are considered. Cervical
      epidural injections are the mainstay of the interventional, non-surgical modalities. They can
      be considered to provide short and long-term relief when disc herniation, foraminal stenosis
      or central canal stenosis pathology is identified.

      Cervical epidural injections can be performed by two different approaches, transforaminal and
      interlaminar. Transforaminal epidural injections allow delivery of medication to the ventral
      epidural space, while the interlaminar approach reaches the ventral epidural space in only
      28% of injections (2-4). The results of cervical epidural injections remain controversial and
      their efficacy in decreasing the need for surgery in patients who would otherwise be
      operative candidates has not been thoroughly investigated. Studies have been limited by small
      sample sizes, lack of control groups, and lack of randomization. Kolstad et al reported that
      23% (5/21) of patients waiting for cervical disc surgery cancelled surgery when assessed at
      four months after having a series of two cervical epidural injections (6). Lin et al reported
      that 63% (44/70) of patients who were deemed to be surgical candidates were able to avoid
      surgery with an average of 13-month follow up (7). Lee et al reported that over 80% of 98
      patients evaluated with cervical radiculopathy were able to avoid surgery with a 2-year
      follow-up (8). Anderberg et al reported that there was no short-term difference in symptoms
      of cervical radiculopathy between patients who received transforaminal injections of steroid
      with local anesthetic versus saline with local anesthetic. However, this study did not
      evaluate whether the injections were successful in the patients avoiding surgery (11).

      In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that steroid
      injections obviated the need for surgery in patients with lumbar radiculopathy. Moreover,
      Reiw et al showed that steroid combined with local anesthetic was more effective than local
      anesthetic alone in a prospective, randomized, controlled, double-blinded study (9). Riew et
      al later studied the efficacy of cervical transforaminal epidural injections in the same
      fashion, but the findings were not statistically significant (p<0.35) and not published (10).

      We are not aware of any published prospective, randomized, controlled, double-blinded studies
      demonstrating the efficacy of cervical transforaminal epidural steroid injections. However,
      the North American Spine Society (NASS) Review and Recommendation Statement states that based
      on the literature and expert opinion, a minimum of one or two cervical epidural steroid
      injections would be very appropriate in the treatment of a specific episode of cervical
      radicular pain. This literature also suggests that a maximum of four injections can be used
      within six months, assuming there was a positive response and improvement seen with the
      previous injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Avoidance of Neck Surgery
time frame: 12 months after the first injection
description: The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.
measure: Disability
time frame: 4 weeks
description: Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
measure: Numeric Pain Scre
time frame: 4 weeks
description: Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
measure: Patient Satisfaction
time frame: 4 weeks
description: Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
measure: Disability
time frame: 12 weeks
description: Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
measure: Disability
time frame: 6 Months
description: Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
measure: Disability
time frame: 12 Months
description: Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
measure: Numeric Pain Score
time frame: 12 weeks
description: Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
measure: Numeric Pain Score
time frame: 6 Months
description: Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
measure: Numeric Pain Score
time frame: 12 Months
description: Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
measure: Patient Satisfaction
time frame: 12 weeks
description: Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
measure: Patient Satisfaction
time frame: 6 months
description: Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
measure: Patient Satisfaction
time frame: 12 months
description: Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
arm group label: Lidocaine
arm group type: Active Comparator
description: Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
arm group label: Lidocaine with Dexamethasone
arm group type: Experimental
description: Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
intervention type: Drug
intervention name: Lidocaine
arm group label: Lidocaine
intervention type: Drug
intervention name: Lidocaine with Dexamethasone
arm group label: Lidocaine with Dexamethasone
other name: Lidocaine
other name: Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sam Bhagia, MD
role: Principal Investigator
affiliation: OrthoCarolina Research Institute, Inc.
facility: 
country: United States
citation: Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.
PMID: 8186959
citation: Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011.
PMID: 11880836
citation: Strub WM, Brown TA, Ying J, Hoffmann M, Ernst RJ, Bulas RV. Translaminar cervical epidural steroid injection: short-term results and factors influencing outcome. J Vasc Interv Radiol. 2007 Sep;18(9):1151-5. doi: 10.1016/j.jvir.2007.06.011.
PMID: 17804778
citation: Lieberman R, Dreyfuss P, Baker R. Fluoroscopically guided interlaminar cervical epidural injections. Arch Phys Med Rehabil. 2003 Oct;84(10):1568-9; author reply 1569. doi: 10.1016/j.apmr.2003.08.072. No abstract available.
PMID: 14594016
citation: Manchikanti L, Falco FJ, Diwan S, Hirsch JA, Smith HS. Cervical radicular pain: the role of interlaminar and transforaminal epidural injections. Curr Pain Headache Rep. 2014 Jan;18(1):389. doi: 10.1007/s11916-013-0389-9.
PMID: 24338702
citation: Kolstad F, Leivseth G, Nygaard OP. Transforaminal steroid injections in the treatment of cervical radiculopathy. A prospective outcome study. Acta Neurochir (Wien). 2005 Oct;147(10):1065-70; discussion 1070. doi: 10.1007/s00701-005-0542-2. Epub 2005 Jun 9.
PMID: 15924210
citation: Lin EL, Lieu V, Halevi L, Shamie AN, Wang JC. Cervical epidural steroid injections for symptomatic disc herniations. J Spinal Disord Tech. 2006 May;19(3):183-6. doi: 10.1097/01.bsd.0000190558.13248.e1.
PMID: 16770215
citation: Lee SH, Kim KT, Kim DH, Lee BJ, Son ES, Kwack YH. Clinical outcomes of cervical radiculopathy following epidural steroid injection: a prospective study with follow-up for more than 2 years. Spine (Phila Pa 1976). 2012 May 20;37(12):1041-7. doi: 10.1097/BRS.0b013e31823b4d1f.
PMID: 22024908
citation: Riew KD, Yin Y, Gilula L, Bridwell KH, Lenke LG, Lauryssen C, Goette K. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am. 2000 Nov;82(11):1589-93. doi: 10.2106/00004623-200011000-00012.
PMID: 11097449
citation: Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. Transforaminal steroid injections for the treatment of cervical radiculopathy: a prospective and randomised study. Eur Spine J. 2007 Mar;16(3):321-8. doi: 10.1007/s00586-006-0142-8. Epub 2006 Jul 12.
PMID: 16835737
responsible party type: Sponsor
mesh term: Pain
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Lidocaine
mesh term: BB 1101
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 