<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/NCT03274570</url>
  </required_header>
  <id_info>
    <org_study_id>Hand function in RA</org_study_id>
    <nct_id>NCT03274570</nct_id>
  </id_info>
  <brief_title>Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life</brief_title>
  <official_title>Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of the research are:&#xD;
&#xD;
        -  To predict factors affecting hand dysfunction in patient with rheumatoid arthritis&#xD;
&#xD;
        -  To study the effect of hand dysfunction on quality of life in patient with rheumatoid&#xD;
           arthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory&#xD;
      arthritis, associated with considerable impairments of Quality of life .&#xD;
&#xD;
      Hand is the principle means by which an individual interacts with people and objects in the&#xD;
      external environment .Many factors affect hand function in addition to arthritis ,. Many RA&#xD;
      patients suffer from an increased loss of muscle mass with a significant impact on these&#xD;
      patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis&#xD;
      multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA&#xD;
      .So assessment of factors causing hand dysfunction can provide us a quick and early insight&#xD;
      on the debilitating effects of RA on functioning and disability.Thus Early intervention can&#xD;
      then be initiated which will help limit joint damage and thereby improve functional outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>quality of life</measure>
    <time_frame>one year</time_frame>
    <description>Health assessment questionnaire disability index (HAQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hand function</measure>
    <time_frame>one year</time_frame>
    <description>measured by musculoskeletal ultrasound</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      CBC;ESR,liver function test and kidney function test&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patient attending the Rheumatology and Rehabilitation outpatient clinic and in-patient&#xD;
        department, Faculty of Medicine, Assuit University Hospitals during the period from&#xD;
        September 2017 until September 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010)&#xD;
             criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and&#xD;
             in-patient department, Faculty of Medicine, Assuit University Hospitals.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other rheumatic diseases.&#xD;
&#xD;
          -  Patients less than 18 years old.&#xD;
&#xD;
          -  Patients with co-morbidities influencing disease activity and hand function (e.g.,&#xD;
             end- stage liver or renal disease, serious infections, or severe cardiac, respiratory,&#xD;
             gastrointestinal disease) .&#xD;
&#xD;
          -  Patient with any recent history of hand trauma, or surgery.&#xD;
&#xD;
          -  Patient with neurological involvement as , peripheral neuropathy and radiculopathy&#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>Safaa A Mahran, professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Essam Abda, professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Essraa abd el razek, doctor</last_name>
    <phone>01009558495</phone>
    <email>essraamohammed2016@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manal Hassanien, lecturer</last_name>
    <phone>01062679200</phone>
    <email>manal_hassanien@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Essraa Mohammed</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03274570
org study id: Hand function in RA
nct id: NCT03274570
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aims of the research are:

        -  To predict factors affecting hand dysfunction in patient with rheumatoid arthritis

        -  To study the effect of hand dysfunction on quality of life in patient with rheumatoid
           arthritis
Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory
      arthritis, associated with considerable impairments of Quality of life .

      Hand is the principle means by which an individual interacts with people and objects in the
      external environment .Many factors affect hand function in addition to arthritis ,. Many RA
      patients suffer from an increased loss of muscle mass with a significant impact on these
      patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis
      multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA
      .So assessment of factors causing hand dysfunction can provide us a quick and early insight
      on the debilitating effects of RA on functioning and disability.Thus Early intervention can
      then be initiated which will help limit joint damage and thereby improve functional outcomes.
observational model: Case-Only
time perspective: Cross-Sectional
measure: quality of life
time frame: one year
description: Health assessment questionnaire disability index (HAQ)
measure: hand function
time frame: one year
description: measured by musculoskeletal ultrasound
CBC;ESR,liver function test and kidney function test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Safaa A Mahran, professor
role: Study Director
affiliation: Assiut University
last name: Essam Abda, professor
role: Study Director
affiliation: Assiut University
last name: Essraa abd el razek, doctor
phone: 01009558495
email: essraamohammed2016@yahoo.com
last name: Manal Hassanien, lecturer
phone: 01062679200
email: manal_hassanien@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Essraa Mohammed
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid