<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/NCT02252939</url>
  </required_header>
  <id_info>
    <org_study_id>2013P000827</org_study_id>
    <nct_id>NCT02252939</nct_id>
  </id_info>
  <brief_title>Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition</brief_title>
  <official_title>Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are doing this research study to discover factors, such as job, hobbies, or&#xD;
      race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis&#xD;
      is one of the most common kinds of arthritis. About 116 people will take part in this&#xD;
      research study at Massachusetts General Hospital (MGH).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age</measure>
    <time_frame>Baseline at Day 1</time_frame>
    <description>Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint</measure>
    <time_frame>Day 1, baseline</time_frame>
    <description>Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH (Disability of the Arm, Shoulder, and Hand)</measure>
    <time_frame>Day 1, baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Trapeziometacarpal Arthrosis</condition>
  <arm_group>
    <arm_group_label>Patients with Trapeziometacarpal (TMC) Arthrosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>X-Ray</intervention_name>
    <description>X-ray as part of standard care</description>
    <arm_group_label>Patients with Trapeziometacarpal (TMC) Arthrosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  55 years and older&#xD;
&#xD;
          -  Not seeking care for TMC arthrosis from hand surgeon at the time of visit&#xD;
&#xD;
          -  english fluency and literacy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 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>
  <reference>
    <citation>Allegrante JP, Marks R. Self-efficacy in management of osteoarthritis. Rheum Dis Clin North Am. 2003 Nov;29(4):747-68, vi-vii. doi: 10.1016/s0889-857x(03)00060-7.</citation>
    <PMID>14603581</PMID>
  </reference>
  <reference>
    <citation>Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M. Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis. 2010 Mar;69(3):585-7. doi: 10.1136/ard.2009.104562. Epub 2010 Feb 2. Erratum In: Ann Rheum Dis. 2011 Nov;70(11):2060. Ann Rheum Dis. 2012 Jun;71(6):1106.</citation>
    <PMID>20124359</PMID>
  </reference>
  <reference>
    <citation>Buckelew SP, Parker JC. Coping with arthritis pain. A review of the literature. Arthritis Care Res. 1989 Dec;2(4):136-45. doi: 10.1002/anr.1790020408.</citation>
    <PMID>2487718</PMID>
  </reference>
  <reference>
    <citation>Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16. Erratum In: Ann Rheum Dis. 2005 Aug;64(8):1248.</citation>
    <PMID>15374852</PMID>
  </reference>
  <reference>
    <citation>Das De S, Vranceanu AM, Ring DC. Contribution of kinesophobia and catastrophic thinking to upper-extremity-specific disability. J Bone Joint Surg Am. 2013 Jan 2;95(1):76-81. doi: 10.2106/JBJS.L.00064.</citation>
    <PMID>23283376</PMID>
  </reference>
  <reference>
    <citation>DeGood DE, Tait RC. Assessment of pain beliefs and pain coping. In: Turk DC, Melzack R (Eds.) Handbook of pain assessment, 2nd ed. New York, Guilford Press, 2001: 320-45.</citation>
  </reference>
  <reference>
    <citation>Dolce JJ, Crocker MF, Moletteire C, Doleys DM. Exercise quotas, anticipatory concern and self-efficacy expectancies in chronic pain: a preliminary report. Pain. 1986 Mar;24(3):365-372. doi: 10.1016/0304-3959(86)90122-3.</citation>
    <PMID>3960576</PMID>
  </reference>
  <reference>
    <citation>Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013.</citation>
    <PMID>15252092</PMID>
  </reference>
  <reference>
    <citation>Hoffman BM, Papas RK, Chatkoff DK, Kerns RD. Meta-analysis of psychological interventions for chronic low back pain. Health Psychol. 2007 Jan;26(1):1-9. doi: 10.1037/0278-6133.26.1.1.</citation>
    <PMID>17209691</PMID>
  </reference>
  <reference>
    <citation>Jensen MP, Turner JA, Romano JM, Karoly P. Coping with chronic pain: a critical review of the literature. Pain. 1991 Dec;47(3):249-283. doi: 10.1016/0304-3959(91)90216-K.</citation>
    <PMID>1784498</PMID>
  </reference>
  <reference>
    <citation>Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.</citation>
    <PMID>2912463</PMID>
  </reference>
  <reference>
    <citation>Lozano-Calderon SA, Souer JS, Jupiter JB, Ring D. Psychological differences between patients that elect operative or nonoperative treatment for trapeziometacarpal joint arthrosis. Hand (N Y). 2008 Sep;3(3):271-5. doi: 10.1007/s11552-008-9098-y. Epub 2008 Mar 29.</citation>
    <PMID>18780109</PMID>
  </reference>
  <reference>
    <citation>Marshall M, van der Windt D, Nicholls E, Myers H, Dziedzic K. Radiographic thumb osteoarthritis: frequency, patterns and associations with pain and clinical assessment findings in a community-dwelling population. Rheumatology (Oxford). 2011 Apr;50(4):735-9. doi: 10.1093/rheumatology/keq371. Epub 2010 Dec 6.</citation>
    <PMID>21134961</PMID>
  </reference>
  <reference>
    <citation>Ring D, Guss D, Malhotra L, Jupiter JB. Idiopathic arm pain. J Bone Joint Surg Am. 2004 Jul;86(7):1387-91. doi: 10.2106/00004623-200407000-00005.</citation>
    <PMID>15252084</PMID>
  </reference>
  <reference>
    <citation>Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.</citation>
    <PMID>16322609</PMID>
  </reference>
  <reference>
    <citation>Vranceanu AM, Barsky A, Ring D. Psychosocial aspects of disabling musculoskeletal pain. J Bone Joint Surg Am. 2009 Aug;91(8):2014-8. doi: 10.2106/JBJS.H.01512.</citation>
    <PMID>19651964</PMID>
  </reference>
  <reference>
    <citation>Wolf JM, Delaronde S. Current trends in nonoperative and operative treatment of trapeziometacarpal osteoarthritis: a survey of US hand surgeons. J Hand Surg Am. 2012 Jan;37(1):77-82. doi: 10.1016/j.jhsa.2011.10.010. Epub 2011 Nov 25.</citation>
    <PMID>22119601</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>September 5, 2017</results_first_submitted>
  <results_first_submitted_qc>October 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patients With Trapeziometacarpal (TMC) Arthrosis</title>
          <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </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="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patients With Trapeziometacarpal (TMC) Arthrosis</title>
          <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="61" upper_limit="76"/>
                  </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="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age</title>
        <description>Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.</description>
        <time_frame>Baseline at Day 1</time_frame>
        <population>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Trapeziometacarpal Arthrosis Eaton Stage I</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage I&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
          <group group_id="O2">
            <title>Patients With Trapeziometacarpal Arthrosis Eaton Stage II</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage II&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
          <group group_id="O3">
            <title>Patients With Trapeziometacarpal Arthrosis Eaton Stage III-IV</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis, Eaton Stage III-IV&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
        </group_list>
        <measure>
          <title>Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age</title>
          <description>Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.</description>
          <population>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</population>
          <units>Years</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="36"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="56" upper_limit="66"/>
                    <measurement group_id="O2" value="66" lower_limit="62" upper_limit="70"/>
                    <measurement group_id="O3" value="75" lower_limit="66" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint</title>
        <description>Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)</description>
        <time_frame>Day 1, baseline</time_frame>
        <population>All patients with TMC Arthrosis analyzed for hyperextension of MCP joint.</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Thumb Pain</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis with thumb pain&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
          <group group_id="O2">
            <title>Patients Without Thumb Pain</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis with thumb pain&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
        </group_list>
        <measure>
          <title>Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint</title>
          <description>Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)</description>
          <population>All patients with TMC Arthrosis analyzed for hyperextension of MCP joint.</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="11"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>QuickDASH (Disability of the Arm, Shoulder, and Hand)</title>
        <time_frame>Day 1, baseline</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Patients With Trapeziometacarpal (TMC) Arthrosis</title>
            <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</description>
          </group>
        </group_list>
        <measure>
          <title>QuickDASH (Disability of the Arm, Shoulder, and Hand)</title>
          <population>Data were not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Patients With Trapeziometacarpal (TMC) Arthrosis</title>
          <description>Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis&#xD;
X-Ray: X-ray as part of standard care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="59"/>
              </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="59"/>
              </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>Rachel Gottlieb, Research Coordinator</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-726-1569</phone>
      <email>rgottileb3@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/NCT02252939
org study id: 2013P000827
nct id: NCT02252939
lead sponsor: 
has dmc: No
The investigators are doing this research study to discover factors, such as job, hobbies, or
      race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis
      is one of the most common kinds of arthritis. About 116 people will take part in this
      research study at Massachusetts General Hospital (MGH).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age
time frame: Baseline at Day 1
description: Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.
measure: Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint
time frame: Day 1, baseline
description: Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)
measure: QuickDASH (Disability of the Arm, Shoulder, and Hand)
time frame: Day 1, baseline
arm group label: Patients with Trapeziometacarpal (TMC) Arthrosis
arm group type: Experimental
description: Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis
intervention type: Radiation
intervention name: X-Ray
description: X-ray as part of standard care
arm group label: Patients with Trapeziometacarpal (TMC) Arthrosis
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Neal Chen, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
citation: Allegrante JP, Marks R. Self-efficacy in management of osteoarthritis. Rheum Dis Clin North Am. 2003 Nov;29(4):747-68, vi-vii. doi: 10.1016/s0889-857x(03)00060-7.
PMID: 14603581
citation: Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M. Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis. 2010 Mar;69(3):585-7. doi: 10.1136/ard.2009.104562. Epub 2010 Feb 2. Erratum In: Ann Rheum Dis. 2011 Nov;70(11):2060. Ann Rheum Dis. 2012 Jun;71(6):1106.
PMID: 20124359
citation: Buckelew SP, Parker JC. Coping with arthritis pain. A review of the literature. Arthritis Care Res. 1989 Dec;2(4):136-45. doi: 10.1002/anr.1790020408.
PMID: 2487718
citation: Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16. Erratum In: Ann Rheum Dis. 2005 Aug;64(8):1248.
PMID: 15374852
citation: Das De S, Vranceanu AM, Ring DC. Contribution of kinesophobia and catastrophic thinking to upper-extremity-specific disability. J Bone Joint Surg Am. 2013 Jan 2;95(1):76-81. doi: 10.2106/JBJS.L.00064.
PMID: 23283376
citation: DeGood DE, Tait RC. Assessment of pain beliefs and pain coping. In: Turk DC, Melzack R (Eds.) Handbook of pain assessment, 2nd ed. New York, Guilford Press, 2001: 320-45.
citation: Dolce JJ, Crocker MF, Moletteire C, Doleys DM. Exercise quotas, anticipatory concern and self-efficacy expectancies in chronic pain: a preliminary report. Pain. 1986 Mar;24(3):365-372. doi: 10.1016/0304-3959(86)90122-3.
PMID: 3960576
citation: Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013.
PMID: 15252092
citation: Hoffman BM, Papas RK, Chatkoff DK, Kerns RD. Meta-analysis of psychological interventions for chronic low back pain. Health Psychol. 2007 Jan;26(1):1-9. doi: 10.1037/0278-6133.26.1.1.
PMID: 17209691
citation: Jensen MP, Turner JA, Romano JM, Karoly P. Coping with chronic pain: a critical review of the literature. Pain. 1991 Dec;47(3):249-283. doi: 10.1016/0304-3959(91)90216-K.
PMID: 1784498
citation: Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
PMID: 2912463
citation: Lozano-Calderon SA, Souer JS, Jupiter JB, Ring D. Psychological differences between patients that elect operative or nonoperative treatment for trapeziometacarpal joint arthrosis. Hand (N Y). 2008 Sep;3(3):271-5. doi: 10.1007/s11552-008-9098-y. Epub 2008 Mar 29.
PMID: 18780109
citation: Marshall M, van der Windt D, Nicholls E, Myers H, Dziedzic K. Radiographic thumb osteoarthritis: frequency, patterns and associations with pain and clinical assessment findings in a community-dwelling population. Rheumatology (Oxford). 2011 Apr;50(4):735-9. doi: 10.1093/rheumatology/keq371. Epub 2010 Dec 6.
PMID: 21134961
citation: Ring D, Guss D, Malhotra L, Jupiter JB. Idiopathic arm pain. J Bone Joint Surg Am. 2004 Jul;86(7):1387-91. doi: 10.2106/00004623-200407000-00005.
PMID: 15252084
citation: Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.
PMID: 16322609
citation: Vranceanu AM, Barsky A, Ring D. Psychosocial aspects of disabling musculoskeletal pain. J Bone Joint Surg Am. 2009 Aug;91(8):2014-8. doi: 10.2106/JBJS.H.01512.
PMID: 19651964
citation: Wolf JM, Delaronde S. Current trends in nonoperative and operative treatment of trapeziometacarpal osteoarthritis: a survey of US hand surgeons. J Hand Surg Am. 2012 Jan;37(1):77-82. doi: 10.1016/j.jhsa.2011.10.010. Epub 2011 Nov 25.
PMID: 22119601
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Neal Chung-Jen Chen
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Joint Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 