<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/NCT03291197</url>
  </required_header>
  <id_info>
    <org_study_id>20170066-01H</org_study_id>
    <nct_id>NCT03291197</nct_id>
  </id_info>
  <brief_title>Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome</brief_title>
  <official_title>Assessing the Tolerability of Suprascapular and Median Nerve Blocks for the Treatment of Shoulder-hand Syndrome - a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life.&#xD;
      Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating&#xD;
      it can be hard. Recent research has shown that certain nerve blocks are good for treating&#xD;
      shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators&#xD;
      think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve)&#xD;
      and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will&#xD;
      use ultrasound guidance to accurately inject these nerves. These injections have never been&#xD;
      described for SHS patients however, so investigators want to make sure people with SHS can go&#xD;
      through with the injections without too much pain or discomfort. That is, the investigators&#xD;
      want to test the tolerance of these injections for people with SHS. Investigators are also&#xD;
      hoping to better understand how consistent a set of diagnostic criteria, called the Budapest&#xD;
      criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">October 14, 2018</completion_date>
  <primary_completion_date type="Actual">October 14, 2018</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>Open label preliminary study testing the tolerability of the procedure.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>measured at baseline, within 1 hour after, and 2 weeks post intervention</time_frame>
    <description>Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter-rater Agreement of Budapest Criteria</measure>
    <time_frame>12 months</time_frame>
    <description>Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Shoulder Hand Syndrome</condition>
  <condition>Complex Regional Pain Syndromes</condition>
  <arm_group>
    <arm_group_label>Open label treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These patients will receive suprascapular and median nerve blocks for shoulder hand syndrome. Investigators will assess the tolerability of his procedure using pre-defined criteria (outlined elsewhere).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Suprascapular and median nerve blocks</intervention_name>
    <description>Ultrasound guided injection of the median and suprascapular nerve of the affected side.</description>
    <arm_group_label>Open label treatment</arm_group_label>
    <other_name>Bupivacaine, kenalog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are required to be 18 years of age or older and have a presumptive diagnosis&#xD;
             of SHS post-stroke with a minimum visual analog scale of 40mm (greater than 40mm is&#xD;
             considered moderate pain).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded from the study if they have significant cognitive impairment&#xD;
             (mini-mental state examination &lt;23) and language deficits (difficulty cooperating due&#xD;
             to aphasia) as this may affect their response to the outcome measures. Subjects with&#xD;
             uncontrolled hypertension (&gt;180/110), septicemia, and brachial plexus injuries will be&#xD;
             excluded. Patients who are blind and deaf will also be excluded, as they will be&#xD;
             unable to adequately complete the post-procedure survey and VAS. Patients on&#xD;
             anticoagulation medications will also be excluded on a case-by-case basis and&#xD;
             medications will be held prior to injection if required for safety. Patients with INR&#xD;
             &gt;1.5 will be excluded.&#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>T Mark Campbell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Elisabeth Bruyere Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1N5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>July 3, 2019</results_first_submitted>
  <results_first_submitted_qc>September 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 30, 2019</results_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suprascapular nerve block</keyword>
  <keyword>Median nerve block</keyword>
  <keyword>CRPS</keyword>
  <keyword>Shoulder hand syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Complex Regional Pain Syndromes</mesh_term>
    <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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>April 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03291197/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period was from September 2017 to 2018. This was a 12 month period in which patient with shoulder and hand pain following stroke were recruited.</recruitment_details>
      <pre_assignment_details>All participants were recruited to for suprascapular and median nerve blocks once a diagnosis of shoulder-hand-syndrome was made using the Budapest criteria</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Open Label Treatment</title>
          <description>These patients received suprascapular and median nerve blocks for shoulder hand syndrome. Investigators assessed the tolerability of his procedure using pre-defined criteria (outlined elsewhere).&#xD;
Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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>Open Label Treatment</title>
          <description>These patients will receive suprascapular and median nerve blocks for shoulder hand syndrome. Investigators will assess the tolerability of his procedure using pre-defined criteria (outlined elsewhere).&#xD;
Suprascapular and median nerve blocks: Ultrasound guided injection of the median and suprascapular nerve of the affected side.&#xD;
Outcome measure were recorded for each participant before, immediately after, and 2 weeks post intervention.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.5" spread="9.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Right Hand Dominant</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mini Mental Status Exam</title>
          <description>Cognitive test. Total score out of 30 points. A total score below 24 is considered cognitively impaired. We are not including subscales and report only on the total score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke Location</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Right middle cerebral artery</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right posterior limb of internal capsule</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Left pons</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time interval, days</title>
          <description>The number of days from the date of study enrolment to the date the participants received peripheral nerve injections.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks</title>
        <description>To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.</description>
        <time_frame>12 months</time_frame>
        <population>All participants tolerated the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Tolerability</title>
            <description>Composite score of: a) change in VAS by &gt; 18mm; b) rate of serious adverse events; c) level of patient satisfaction</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks</title>
          <description>To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.</description>
          <population>All participants tolerated the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS)</title>
        <description>Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.</description>
        <time_frame>measured at baseline, within 1 hour after, and 2 weeks post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Baseline VAS</title>
            <description>visual analog pain scale at baseline prior to intervention</description>
          </group>
          <group group_id="O2">
            <title>1 Hour VAS</title>
            <description>VAS measured within 1 hour after intervetion</description>
          </group>
          <group group_id="O3">
            <title>2 Weeks VAS</title>
            <description>VAS measured 2 weeks post intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS)</title>
          <description>Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Shoulder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="66.5" upper_limit="90.5"/>
                    <measurement group_id="O2" value="17" lower_limit="0" upper_limit="29.5"/>
                    <measurement group_id="O3" value="22" lower_limit="0" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="24.5" upper_limit="80.5"/>
                    <measurement group_id="O2" value="16" lower_limit="0" upper_limit="32.5"/>
                    <measurement group_id="O3" value="28" lower_limit="0" upper_limit="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inter-rater Agreement of Budapest Criteria</title>
        <description>Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants will be assessed using the Budapest Criteria by both a staff physician and a resident. The inter-rater agreement will be determined to assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS.</description>
          </group>
        </group_list>
        <measure>
          <title>Inter-rater Agreement of Budapest Criteria</title>
          <description>Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.</description>
          <units>Intraclass correlation coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during and immediately following the procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tolerability</title>
          <description>Composite score</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="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </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="5"/>
              </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>Some of these results should be considered hypothesis-generating due to the small sample size of our study, and the inability to assess other factors that may affect the response to pain (i.e. co-morbidities, psychological profile).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Marc Monsour</name_or_title>
      <organization>Physical Medicine and Rehabilitation Ottawa Resident</organization>
      <phone>6137377350</phone>
      <email>mmonsour051@gmail.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/NCT03291197
org study id: 20170066-01H
nct id: NCT03291197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shoulder-hand syndrome (SHS) in stroke patients is painful and lowers quality of life.
      Unfortunately, the cause of SHS is not known, diagnosing SHS can be difficult, and treating
      it can be hard. Recent research has shown that certain nerve blocks are good for treating
      shoulder pain for stroke patients, but no one has looked specifically as SHS. Investigators
      think that specific nerve blocks involving a shoulder nerve (the suprascapular, or SSc nerve)
      and a hand nerve (the median nerve) will be helpful in reducing SHS pain. Investigators will
      use ultrasound guidance to accurately inject these nerves. These injections have never been
      described for SHS patients however, so investigators want to make sure people with SHS can go
      through with the injections without too much pain or discomfort. That is, the investigators
      want to test the tolerance of these injections for people with SHS. Investigators are also
      hoping to better understand how consistent a set of diagnostic criteria, called the Budapest
      criteria, are at diagnosing SHS in order to be able to accurately diagnose this condition.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Open label preliminary study testing the tolerability of the procedure.
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks
time frame: 12 months
description: To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.
measure: Visual Analog Scale (VAS)
time frame: measured at baseline, within 1 hour after, and 2 weeks post intervention
description: Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.
measure: Inter-rater Agreement of Budapest Criteria
time frame: 12 months
description: Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.
arm group label: Open label treatment
arm group type: Experimental
description: These patients will receive suprascapular and median nerve blocks for shoulder hand syndrome. Investigators will assess the tolerability of his procedure using pre-defined criteria (outlined elsewhere).
intervention type: Drug
intervention name: Suprascapular and median nerve blocks
description: Ultrasound guided injection of the median and suprascapular nerve of the affected side.
arm group label: Open label treatment
other name: Bupivacaine, kenalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: T Mark Campbell, MD
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Complex Regional Pain Syndromes
mesh term: Reflex Sympathetic Dystrophy
mesh term: Syndrome
mesh term: Bupivacaine
sharing ipd: Yes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Some of these results should be considered hypothesis-generating due to the small sample size of our study, and the inability to assess other factors that may affect the response to pain (i.e. co-morbidities, psychological profile).
point of contact: 