<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/NCT03789526</url>
  </required_header>
  <id_info>
    <org_study_id>REC-AFMG 2018/6</org_study_id>
    <nct_id>NCT03789526</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus</brief_title>
  <official_title>Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al-Azhar University</source>
  <oversight_info>
    <has_dmc>No</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>
      Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the&#xD;
      management of tenosynovitis in DM patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study will based on follow up study, conducted among patients presenting at&#xD;
      outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes&#xD;
      mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness&#xD;
      grade 3.&#xD;
&#xD;
      All patients will randomized in two groups: Group one: 26 patients DM patients with&#xD;
      tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26&#xD;
      patients DM patients with tenosynovitis were injected by triamcinolone under clinical&#xD;
      guidance.&#xD;
&#xD;
      The affected tendons will scanned and scored for inflammation using ultrasound in all&#xD;
      patients before the triamcinolone injection and then to be reassessed one month after the&#xD;
      injection to determine the change in the tendons in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>
    <intervention_model_description>Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.&#xD;
Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Tenosynovitis pain</measure>
    <time_frame>one month</time_frame>
    <description>changes in VAS scale for pain,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Tenosynovitis tenderness</measure>
    <time_frame>one month</time_frame>
    <description>changes in Richie index for tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes in ultrasound images of the Tenoasynovitis.</measure>
    <time_frame>one month</time_frame>
    <description>changes in Gery scale images, and power Doppler images of the tendons</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Ultrasound Guided Injection</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound guidance</intervention_name>
    <description>ultrasound guidance of tendon injection</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Diabetes mellitus.&#xD;
&#xD;
               -  Disease duration 3 years or more.&#xD;
&#xD;
               -  Tenosynovitis of hand tendons with Richie tenderness grade 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with recent hand trauma.&#xD;
&#xD;
               -  Patients with inflammatory hand arthritis.&#xD;
&#xD;
               -  Previous tendon surgery.&#xD;
&#xD;
               -  Previous tendon injection.&#xD;
&#xD;
               -  Patients with contraindication for injection as related infection, uncontrolled&#xD;
                  DM or bleeding tendency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Al-Azhar university hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 10, 2019</last_update_submitted>
  <last_update_submitted_qc>June 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Ahmed Abogamal</investigator_full_name>
    <investigator_title>clinical professor of Rheumatology</investigator_title>
  </responsible_party>
  <keyword>Tenosynovitis</keyword>
  <keyword>ultrasound</keyword>
  <keyword>diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenosynovitis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03789526
org study id: REC-AFMG 2018/6
nct id: NCT03789526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the
      management of tenosynovitis in DM patients.
The current study will based on follow up study, conducted among patients presenting at
      outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes
      mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness
      grade 3.

      All patients will randomized in two groups: Group one: 26 patients DM patients with
      tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26
      patients DM patients with tenosynovitis were injected by triamcinolone under clinical
      guidance.

      The affected tendons will scanned and scored for inflammation using ultrasound in all
      patients before the triamcinolone injection and then to be reassessed one month after the
      injection to determine the change in the tendons in both groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
primary purpose: Treatment
masking: None (Open Label)
measure: change in Tenosynovitis pain
time frame: one month
description: changes in VAS scale for pain,
measure: change in Tenosynovitis tenderness
time frame: one month
description: changes in Richie index for tenderness.
measure: changes in ultrasound images of the Tenoasynovitis.
time frame: one month
description: changes in Gery scale images, and power Doppler images of the tendons
arm group label: Group 1
arm group type: Experimental
description: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
arm group label: Group 2
arm group type: No Intervention
description: Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
intervention type: Procedure
intervention name: ultrasound guidance
description: ultrasound guidance of tendon injection
arm group label: Group 1
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Ahmed Abogamal
investigator title: clinical professor of Rheumatology
mesh term: Tenosynovitis
mesh term: Diabetes Mellitus
sharing ipd: No