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/NCT05999266</url>
    </required_header>
    <id_info>
      <org_study_id>15082023</org_study_id>
      <nct_id>NCT05999266</nct_id>
    </id_info>
    <brief_title>The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis</brief_title>
    <official_title>The Effect of Ultrasonographic Cartilage Thickness and Quadriceps/Hamstring Muscle Thickness on Knee Pain in Patients With 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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The knee pain status of the patients who are followed in the rheumatology special branch of&#xD;
        the Physical Medicine and Rehabilitation Outpatient Clinic and who meet the inclusion&#xD;
        criteria will be questioned. In patients with or without knee pain, the cartilage thickness&#xD;
        measurement of the knee joint will be measured from 3 points by ultrasound. At the same time,&#xD;
        Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the&#xD;
        midpoints where the muscle thickness is the highest. The physician who performed the&#xD;
        ultrasonographic measurements of the knee pain status of the patients does not know.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Week</target_duration>
    <primary_outcome>
      <measure>Ultrasonographic Cartilage Thickness Measurement</measure>
      <time_frame>through study completion, an average of 1 month</time_frame>
      <description>Tibial cartilage thickness will be visualized by ultrasound with the knee held in 30 degrees of flexion, and 3 measurements will be taken from the medial, lateral and midline.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ultrasonographic Muscle Measurement Thickness Measurement</measure>
      <time_frame>through study completion, an average of 1 month</time_frame>
      <description>The quadriceps muscle thickness will be measured by determining the midpoint between the SIAS and the patella while the patient is lying in the supine position. Hamstring muscle thickness will be measured at the intersection of a line drawn at 60% distal between the greater trochanter and the outer femoral condyle, and at the midline of the popliteal fossa, with the patient lying on the prone. These 2 measurements will be proportional to each other.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Rheumatoid Arthritis</condition>
    <condition>Knee Pain Chronic</condition>
    <condition>Muscle Loss</condition>
    <condition>Cartilage Degeneration</condition>
    <arm_group>
      <arm_group_label>Rheumatoid Arthritis Patients with Knee Pain</arm_group_label>
      <description>In patients with knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rheumatoid Arthritis Patients without Knee Pain</arm_group_label>
      <description>In patients without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasonographic Measurements</intervention_name>
      <description>In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.</description>
      <arm_group_label>Rheumatoid Arthritis Patients with Knee Pain</arm_group_label>
      <arm_group_label>Rheumatoid Arthritis Patients without Knee Pain</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Rheumatoid Arthritis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Rheumatoid Arthritis &gt; Diagnosed for 1 year&#xD;
  &#xD;
            -  -Female gender&#xD;
  &#xD;
            -  -The patient has been in remission or low disease activity for at least 3 months&#xD;
  &#xD;
            -  -Be able to ambulatory&#xD;
  &#xD;
            -  -No significant deformity in the lower extremity joints&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with active arthritis or high disease activity&#xD;
  &#xD;
                 -  - Significant deformity of the lower extremity joints and inability to ambulate&#xD;
  &#xD;
                 -  -Pregnant patient&#xD;
  &#xD;
                 -  - Presence of malignancy&#xD;
  &#xD;
                 -  - Patient with a severe psychiatric disorder and difficulty in cooperation&#xD;
  &#xD;
                 -  - Presence of cardiovascular and pulmonary comorbidities that will prevent&#xD;
                    exercise&#xD;
  &#xD;
                 -  -Male gender&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Aylin Ayyıldız</investigator_full_name>
      <investigator_title>Medical Doctor</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>
  
  
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/NCT05999266
  org study id: 15082023
  nct id: NCT05999266
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The knee pain status of the patients who are followed in the rheumatology special branch of
        the Physical Medicine and Rehabilitation Outpatient Clinic and who meet the inclusion
        criteria will be questioned. In patients with or without knee pain, the cartilage thickness
        measurement of the knee joint will be measured from 3 points by ultrasound. At the same time,
        Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the
        midpoints where the muscle thickness is the highest. The physician who performed the
        ultrasonographic measurements of the knee pain status of the patients does not know.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Ultrasonographic Cartilage Thickness Measurement
  time frame: through study completion, an average of 1 month
  description: Tibial cartilage thickness will be visualized by ultrasound with the knee held in 30 degrees of flexion, and 3 measurements will be taken from the medial, lateral and midline.
  measure: Ultrasonographic Muscle Measurement Thickness Measurement
  time frame: through study completion, an average of 1 month
  description: The quadriceps muscle thickness will be measured by determining the midpoint between the SIAS and the patella while the patient is lying in the supine position. Hamstring muscle thickness will be measured at the intersection of a line drawn at 60% distal between the greater trochanter and the outer femoral condyle, and at the midline of the popliteal fossa, with the patient lying on the prone. These 2 measurements will be proportional to each other.
  arm group label: Rheumatoid Arthritis Patients with Knee Pain
  description: In patients with knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
  arm group label: Rheumatoid Arthritis Patients without Knee Pain
  description: In patients without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
  intervention type: Diagnostic Test
  intervention name: Ultrasonographic Measurements
  description: In patients with or without knee pain, the cartilage thickness measurement of the knee joint will be measured from 3 points by ultrasound. At the same time, Quadriceps and Hamstring muscle thickness measurements of the patients will be made from the midpoints where the muscle thickness is the highest.
  arm group label: Rheumatoid Arthritis Patients with Knee Pain
  arm group label: Rheumatoid Arthritis Patients without Knee Pain
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 30 Years
  maximum age: 50 Years
  responsible party type: Principal Investigator
  investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
  investigator full name: Aylin Ayyıldız
  investigator title: Medical Doctor
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid