<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/NCT02216812</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000561</org_study_id>
    <nct_id>NCT02216812</nct_id>
  </id_info>
  <brief_title>Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?</brief_title>
  <official_title>Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reported prevalence of disproportionate pain and disability among patients recovering&#xD;
      from a fracture of the distal radius varies widely. Literature reports numbers between 1% and&#xD;
      37%, perhaps in part because it is poorly defined, known by so many different names,&#xD;
      subjective, and unverifiable.&#xD;
&#xD;
      The investigators are interested in the effect of vitamin C after distal radius fractures on&#xD;
      objective measurement of finger motion, patient reported outcome measures, and pain&#xD;
      intensity, instead of the previously used, subjective and imprecise criteria for complex&#xD;
      regional pain syndrome.&#xD;
&#xD;
      Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius&#xD;
      fracture will be asked to participate in this clinical trial. Patient will be randomly&#xD;
      assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as&#xD;
      regarded by the treating physician at follow-up or for 6 weeks.&#xD;
&#xD;
      The investigators hypothesize no difference in finger stiffness at 6 weeks measured by&#xD;
      distance to palmar crease of the index through little finger between patients taking vitamin&#xD;
      C or placebo after a distal radius fracture. Additionally, the investigators assess finger&#xD;
      stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper&#xD;
      extremity function and pain score both measured at six months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 22, 2017</completion_date>
  <primary_completion_date type="Actual">December 22, 2017</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance to Palmar Crease Index Through Small Finger</measure>
    <time_frame>Day 1 (baseline), 6 weeks</time_frame>
    <description>To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Active Flexion Index Through Small Finger</measure>
    <time_frame>Day 1 (baseline), 6 weeks</time_frame>
    <description>Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thumb Motion</measure>
    <time_frame>Day 1 (baseline), 6 weeks</time_frame>
    <description>Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Upper Extremity - CAT</measure>
    <time_frame>Day 1 (baseline), 6 weeks, 6 months</time_frame>
    <description>The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>0-10 Ordinal Pain Score</measure>
    <time_frame>Day 1 (baseline), 6 weeks, 6 months</time_frame>
    <description>Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Finger Stiffness</condition>
  <condition>Distal Radius Fracture</condition>
  <arm_group>
    <arm_group_label>500 mg vitamin C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm will take 1 placebo pill per day for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>500 mg vitamin c, 1 pill per day for 6 weeks</intervention_name>
    <arm_group_label>500 mg vitamin C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 placebo pill for 6 weeks</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult (age 18 or greater) patients presenting to the Hand and Orthopaedic Trauma&#xD;
             Services of the Massachusetts General Hospital (MGH) within two weeks of a fracture of&#xD;
             the distal radius, either operatively or nonoperatively treated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe kidney failure, known allergy for vitamin C or pregnancy&#xD;
&#xD;
          -  Multiple fractures, except for ulna fractures&#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>Neal Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>June 29, 2018</results_first_submitted>
  <results_first_submitted_qc>September 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 17, 2018</results_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Neal Chung-Jen Chen</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Finger stiffness</keyword>
  <keyword>Range of motion</keyword>
  <keyword>Distal radius fracture</keyword>
  <keyword>Vitamin C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_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>February 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT02216812/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>500 mg Vitamin C</title>
          <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>500 mg Vitamin C</title>
          <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</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="67"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="134"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="48" spread="17"/>
                    <measurement group_id="B2" value="50" spread="17"/>
                    <measurement group_id="B3" value="49" spread="17"/>
                  </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="47"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Non-causcasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dominant extremity injured</title>
          <description>The number of participants whose injured arm is the same side as that of their dominant hand (i.e., the hand with which they write or perform fine motor skills).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-operative treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Carpal tunnel release</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS Pain Interference CAT</title>
          <description>The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring the amount pain interferes in the subjects' activities. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T scores above 50 represents more of the measured variable than the average. Investigators measured this at enrollment.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" spread="6.4"/>
                    <measurement group_id="B2" value="61" spread="7.1"/>
                    <measurement group_id="B3" value="63" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Distance to Palmar Crease Index Through Small Finger</title>
        <description>To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.</description>
        <time_frame>Day 1 (baseline), 6 weeks</time_frame>
        <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>500 mg Vitamin C</title>
            <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Distance to Palmar Crease Index Through Small Finger</title>
          <description>To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.</description>
          <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="6.7"/>
                    <measurement group_id="O2" value="7.1" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="4.0"/>
                    <measurement group_id="O2" value="2.0" spread="3.8"/>
                  </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>We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.63</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Active Flexion Index Through Small Finger</title>
        <description>Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints</description>
        <time_frame>Day 1 (baseline), 6 weeks</time_frame>
        <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>500 mg Vitamin C</title>
            <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Active Flexion Index Through Small Finger</title>
          <description>Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints</description>
          <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
          <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="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="725" spread="159"/>
                    <measurement group_id="O2" value="732" spread="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="896" spread="108"/>
                    <measurement group_id="O2" value="904" spread="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Thumb Motion</title>
        <description>Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction</description>
        <time_frame>Day 1 (baseline), 6 weeks</time_frame>
        <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>500 mg Vitamin C</title>
            <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Thumb Motion</title>
          <description>Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction</description>
          <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
          <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="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" spread="59"/>
                    <measurement group_id="O2" value="155" spread="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229" spread="49"/>
                    <measurement group_id="O2" value="232" spread="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PROMIS Upper Extremity - CAT</title>
        <description>The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.</description>
        <time_frame>Day 1 (baseline), 6 weeks, 6 months</time_frame>
        <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>500 mg Vitamin C</title>
            <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Upper Extremity - CAT</title>
          <description>The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.</description>
          <population>Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="7.9"/>
                    <measurement group_id="O2" value="27" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" spread="6.9"/>
                    <measurement group_id="O2" value="36" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="8.4"/>
                    <measurement group_id="O2" value="48" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>0-10 Ordinal Pain Score</title>
        <description>Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.</description>
        <time_frame>Day 1 (baseline), 6 weeks, 6 months</time_frame>
        <population>Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up</population>
        <group_list>
          <group group_id="O1">
            <title>500 mg Vitamin C</title>
            <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>0-10 Ordinal Pain Score</title>
          <description>Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.</description>
          <population>Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up</population>
          <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="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.4"/>
                    <measurement group_id="O2" value="3.8" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="2.2"/>
                    <measurement group_id="O2" value="1.8" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="2.3"/>
                    <measurement group_id="O2" value="1.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>500 mg Vitamin C</title>
          <description>Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks&#xD;
500 mg vitamin c, 1 pill per day for 6 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Arm will take 1 placebo pill per day for 6 weeks&#xD;
1 placebo pill for 6 weeks</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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </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="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </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>Dr. Neal Chen</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-4700</phone>
      <email>nchen1@mgh.harvard.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/NCT02216812
org study id: 2014P000561
nct id: NCT02216812
lead sponsor: 
has dmc: Yes
The reported prevalence of disproportionate pain and disability among patients recovering
      from a fracture of the distal radius varies widely. Literature reports numbers between 1% and
      37%, perhaps in part because it is poorly defined, known by so many different names,
      subjective, and unverifiable.

      The investigators are interested in the effect of vitamin C after distal radius fractures on
      objective measurement of finger motion, patient reported outcome measures, and pain
      intensity, instead of the previously used, subjective and imprecise criteria for complex
      regional pain syndrome.

      Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius
      fracture will be asked to participate in this clinical trial. Patient will be randomly
      assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as
      regarded by the treating physician at follow-up or for 6 weeks.

      The investigators hypothesize no difference in finger stiffness at 6 weeks measured by
      distance to palmar crease of the index through little finger between patients taking vitamin
      C or placebo after a distal radius fracture. Additionally, the investigators assess finger
      stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper
      extremity function and pain score both measured at six months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Distance to Palmar Crease Index Through Small Finger
time frame: Day 1 (baseline), 6 weeks
description: To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.
measure: Active Flexion Index Through Small Finger
time frame: Day 1 (baseline), 6 weeks
description: Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints
measure: Thumb Motion
time frame: Day 1 (baseline), 6 weeks
description: Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction
measure: PROMIS Upper Extremity - CAT
time frame: Day 1 (baseline), 6 weeks, 6 months
description: The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.
measure: 0-10 Ordinal Pain Score
time frame: Day 1 (baseline), 6 weeks, 6 months
description: Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.
arm group label: 500 mg vitamin C
arm group type: Experimental
description: Arm will take 1 pill of 500 mg vitamin C per day for 6 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Arm will take 1 placebo pill per day for 6 weeks
intervention type: Drug
intervention name: 500 mg vitamin c, 1 pill per day for 6 weeks
arm group label: 500 mg vitamin C
intervention type: Drug
intervention name: 1 placebo pill for 6 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Chen, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Neal Chung-Jen Chen
investigator title: Medical Doctor
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 