<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/NCT03770091</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY18090019</org_study_id>
    <nct_id>NCT03770091</nct_id>
  </id_info>
  <brief_title>Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis</brief_title>
  <official_title>Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>John Fowler</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40,&#xD;
      which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are&#xD;
      both conservative and surgical with surgical options including osteotomy, bone excision,&#xD;
      ligament reconstruction, and various prosthetic implants. The conservative treatment options,&#xD;
      however, are limited to NSAIDs and bracing or steroid injections.&#xD;
&#xD;
      Advances in topical therapies have the potential to deliver focused treatment to the CMC&#xD;
      joint. Novel treatment of inflammation can potentially reduce inflammation and pain&#xD;
      associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that&#xD;
      has theoretical impact on inflammation reduction in human subjects treated with the topical&#xD;
      foam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in&#xD;
      patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic&#xD;
      surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon&#xD;
      as per standard protocols. Patients who are recommended to follow a conservative treatment&#xD;
      modality and are interested in participating in this study will be randomized into treatment&#xD;
      or control groups. Both groups will undergo symptom assessment, strength testing, and range&#xD;
      of motion testing prior to starting the standard conservative treatment of bracing. The&#xD;
      treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2&#xD;
      weeks for at least 6 hours per night. Control group will use a compression wrap for the same&#xD;
      time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion&#xD;
      testing and symptom assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder, and Hand (DASH) Score</measure>
    <time_frame>2 weeks</time_frame>
    <description>patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thumb Range of Motion</measure>
    <time_frame>2 weeks</time_frame>
    <description>This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Grip Strength</measure>
    <time_frame>2 weeks</time_frame>
    <description>This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pinch Strength</measure>
    <time_frame>2 weeks</time_frame>
    <description>This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Foam and Compression Wrap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will use Theraworx foam and a compression wrap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Foam and Compression Wrap</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will use placebo foam and a compression wrap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foam alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will use Theraworx foam without compression wrap</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Theraworx</intervention_name>
    <description>Theraworx foam applied to skin and/or compression wrap</description>
    <arm_group_label>Foam alone</arm_group_label>
    <arm_group_label>Foam and Compression Wrap</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo foam</description>
    <arm_group_label>Placebo Foam and Compression Wrap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Thumb CMC arthritis&#xD;
&#xD;
          2. greater than or equal to age 18&#xD;
&#xD;
          3. Interested in non-operative treatment of thumb arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recent corticosteroid injection into the thumb joint&#xD;
&#xD;
          2. Non-English speaking&#xD;
&#xD;
          3. skin lesions or rashes on the thumb&#xD;
&#xD;
          4. current use of topical anti-inflammatory medications&#xD;
&#xD;
          5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the&#xD;
             PI)&#xD;
&#xD;
          6. known allergy to magnesium&#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>John R Fowler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univ. of Pittsburgh Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaufmann Building</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <results_first_submitted>June 12, 2021</results_first_submitted>
  <results_first_submitted_qc>July 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 14, 2021</results_first_posted>
  <last_update_submitted>July 13, 2021</last_update_submitted>
  <last_update_submitted_qc>July 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>John Fowler</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT03770091/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Foam and Compression Wrap</title>
          <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
        </group>
        <group group_id="P2">
          <title>Placebo Foam and Compression Wrap</title>
          <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
        </group>
        <group group_id="P3">
          <title>Foam Alone</title>
          <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Foam and Compression Wrap</title>
          <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
        </group>
        <group group_id="B2">
          <title>Placebo Foam and Compression Wrap</title>
          <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
        </group>
        <group group_id="B3">
          <title>Foam Alone</title>
          <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
        </group>
        <group group_id="B4">
          <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="15"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" spread="10"/>
                    <measurement group_id="B2" value="60" spread="8"/>
                    <measurement group_id="B3" value="60" spread="9"/>
                    <measurement group_id="B4" value="60" spread="9"/>
                  </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="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="35"/>
                  </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 group_id="B4" 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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Numeric Pain Rating Scale</title>
        <description>patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foam and Compression Wrap</title>
            <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
          <group group_id="O2">
            <title>Placebo Foam and Compression Wrap</title>
            <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
          </group>
          <group group_id="O3">
            <title>Foam Alone</title>
            <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Pain Rating Scale</title>
          <description>patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.</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="15"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.3"/>
                    <measurement group_id="O2" value="2.4" spread="1.5"/>
                    <measurement group_id="O3" value="3.2" spread="2.1"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA performed</non_inferiority_desc>
            <p_value>0.6</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Disabilities of the Arm, Shoulder, and Hand (DASH) Score</title>
        <description>patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foam and Compression Wrap</title>
            <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
          <group group_id="O2">
            <title>Placebo Foam and Compression Wrap</title>
            <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
          </group>
          <group group_id="O3">
            <title>Foam Alone</title>
            <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
        </group_list>
        <measure>
          <title>Disabilities of the Arm, Shoulder, and Hand (DASH) Score</title>
          <description>patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported</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="15"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="10.9"/>
                    <measurement group_id="O2" value="35.9" spread="17.1"/>
                    <measurement group_id="O3" value="26.35" spread="12.5"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.59</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thumb Range of Motion</title>
        <description>This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foam and Compression Wrap</title>
            <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
          <group group_id="O2">
            <title>Placebo Foam and Compression Wrap</title>
            <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
          </group>
          <group group_id="O3">
            <title>Foam Alone</title>
            <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
        </group_list>
        <measure>
          <title>Thumb Range of Motion</title>
          <description>This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="10"/>
                    <measurement group_id="O2" value="60" spread="12"/>
                    <measurement group_id="O3" value="70" spread="10"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Grip Strength</title>
        <description>This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foam and Compression Wrap</title>
            <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
          <group group_id="O2">
            <title>Placebo Foam and Compression Wrap</title>
            <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
          </group>
          <group group_id="O3">
            <title>Foam Alone</title>
            <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
        </group_list>
        <measure>
          <title>Grip Strength</title>
          <description>This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="9.6"/>
                    <measurement group_id="O2" value="67" spread="8.7"/>
                    <measurement group_id="O3" value="72" spread="9.4"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.45</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pinch Strength</title>
        <description>This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Foam and Compression Wrap</title>
            <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
          <group group_id="O2">
            <title>Placebo Foam and Compression Wrap</title>
            <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
          </group>
          <group group_id="O3">
            <title>Foam Alone</title>
            <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
          </group>
        </group_list>
        <measure>
          <title>Pinch Strength</title>
          <description>This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="10.5"/>
                    <measurement group_id="O2" value="29" spread="17.1"/>
                    <measurement group_id="O3" value="25" spread="14.7"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Collected information on reactions to foam or placebo over course of study (2 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Foam and Compression Wrap</title>
          <description>Patients will use Theraworx foam and a compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</description>
        </group>
        <group group_id="E2">
          <title>Placebo Foam and Compression Wrap</title>
          <description>Patients will use placebo foam and a compression wrap&#xD;
Placebo: Placebo foam</description>
        </group>
        <group group_id="E3">
          <title>Foam Alone</title>
          <description>Patients will use Theraworx foam without compression wrap&#xD;
Theraworx: Theraworx foam applied to skin and/or compression wrap</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </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>John Fowler</name_or_title>
      <organization>UPMC</organization>
      <phone>412-605-3245</phone>
      <email>fowlerjr@upmc.edu</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/NCT03770091
org study id: STUDY18090019
nct id: NCT03770091
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40,
      which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are
      both conservative and surgical with surgical options including osteotomy, bone excision,
      ligament reconstruction, and various prosthetic implants. The conservative treatment options,
      however, are limited to NSAIDs and bracing or steroid injections.

      Advances in topical therapies have the potential to deliver focused treatment to the CMC
      joint. Novel treatment of inflammation can potentially reduce inflammation and pain
      associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that
      has theoretical impact on inflammation reduction in human subjects treated with the topical
      foam.
This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in
      patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic
      surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon
      as per standard protocols. Patients who are recommended to follow a conservative treatment
      modality and are interested in participating in this study will be randomized into treatment
      or control groups. Both groups will undergo symptom assessment, strength testing, and range
      of motion testing prior to starting the standard conservative treatment of bracing. The
      treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2
      weeks for at least 6 hours per night. Control group will use a compression wrap for the same
      time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion
      testing and symptom assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Numeric Pain Rating Scale
time frame: 2 weeks
description: patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Score
time frame: 2 weeks
description: patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported
measure: Thumb Range of Motion
time frame: 2 weeks
description: This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.
measure: Grip Strength
time frame: 2 weeks
description: This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks
measure: Pinch Strength
time frame: 2 weeks
description: This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks
arm group label: Foam and Compression Wrap
arm group type: Experimental
description: Patients will use Theraworx foam and a compression wrap
arm group label: Placebo Foam and Compression Wrap
arm group type: Placebo Comparator
description: Patients will use placebo foam and a compression wrap
arm group label: Foam alone
arm group type: Experimental
description: Patients will use Theraworx foam without compression wrap
intervention type: Drug
intervention name: Theraworx
description: Theraworx foam applied to skin and/or compression wrap
arm group label: Foam alone
arm group label: Foam and Compression Wrap
intervention type: Drug
intervention name: Placebo
description: Placebo foam
arm group label: Placebo Foam and Compression Wrap
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John R Fowler, MD
role: Principal Investigator
affiliation: Univ. of Pittsburgh Orthopaedic Surgery
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: John Fowler
investigator title: Assistant Professor
mesh term: Arthritis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 