xml: <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/NCT05975281</url>
    </required_header>
    <id_info>
      <org_study_id>28052023</org_study_id>
      <nct_id>NCT05975281</nct_id>
    </id_info>
    <brief_title>Neuropathic Pain Symptoms in Arthritis</brief_title>
    <official_title>Comparison of Neuropathic Pain Symptoms in Hand Osteoarthritis and Rheumatoid Arthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sisli Hamidiye Etfal Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid&#xD;
        arthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid&#xD;
        arthritis who applied to the Physical Medicine and Rehabilitation Clinic of our hospital will&#xD;
        be included. In both patient groups, the duration, character and treatments of their&#xD;
        complaints will be compared. Neuropathic pain will be evaluated with the Visual Analog Score&#xD;
        (VAS), Dolor Neuropathic 4 Questions (DN-4) and Pain Detect pain questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 27, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale</measure>
      <time_frame>Day 1</time_frame>
      <description>0-10 ; higher score : severe pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DN-4</measure>
      <time_frame>Day 1</time_frame>
      <description>0-10 ; &gt; 4 neuropathic pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain detect pain questionnaire</measure>
      <time_frame>Day 1</time_frame>
      <description>0-38 ; &lt; 13 negative, 13-18 unclear, &gt;18 positive</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Neuropathic Pain</condition>
    <arm_group>
      <arm_group_label>Hand osteoarthritis</arm_group_label>
      <description>Those diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rheumatoid arthritis</arm_group_label>
      <description>Those diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid&#xD;
          arthritis who applied to the Physical Medicine and Rehabilitation Clinic of Şişli Hamidiye&#xD;
          Etfal Training and Research Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of Hand Osteoarthritis and Rheumatoid Arthritis&#xD;
  &#xD;
            -  Presence of neuropathic complaints&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of hand injury, peripheral nerve injury, fracture, and hand operation in the&#xD;
               last 3 months&#xD;
  &#xD;
            -  Do not want to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Selda Çiftci, MD</last_name>
      <phone>+905414857850</phone>
      <email>seldavd@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Şişli Hamidiye Etfal Training and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Selda Çiftci</investigator_full_name>
      <investigator_title>Medical Doctor, Department of Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>hand osteoarthritis</keyword>
    <keyword>neuropathic pain</keyword>
    <keyword>neuropathic symptom</keyword>
    <keyword>rheumatoid arthritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975281
  org study id: 28052023
  nct id: NCT05975281
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid
        arthritis.
  The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid
        arthritis who applied to the Physical Medicine and Rehabilitation Clinic of our hospital will
        be included. In both patient groups, the duration, character and treatments of their
        complaints will be compared. Neuropathic pain will be evaluated with the Visual Analog Score
        (VAS), Dolor Neuropathic 4 Questions (DN-4) and Pain Detect pain questionnaire.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Visual Analog Scale
  time frame: Day 1
  description: 0-10 ; higher score : severe pain
  measure: DN-4
  time frame: Day 1
  description: 0-10 ; > 4 neuropathic pain
  measure: Pain detect pain questionnaire
  time frame: Day 1
  description: 0-38 ; < 13 negative, 13-18 unclear, >18 positive
  arm group label: Hand osteoarthritis
  description: Those diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria
  arm group label: Rheumatoid arthritis
  description: Those diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Selda Çiftci, MD
  phone: +905414857850
  email: seldavd@gmail.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
  investigator full name: Selda Çiftci
  investigator title: Medical Doctor, Department of Physical Medicine and Rehabilitation
  mesh term: Arthritis
  mesh term: Neuralgia
  mesh term: Pain