<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/NCT03790969</url>
  </required_header>
  <id_info>
    <org_study_id>JEP-2018-654</org_study_id>
    <nct_id>NCT03790969</nct_id>
  </id_info>
  <brief_title>Minimizing Pain Experience In Trigger Finger Steroid Injection.</brief_title>
  <official_title>Minimizing Pain Experience In Trigger Finger Steroid Injection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Malaysia</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the pain experience of trigger finger steroid injection with 26 gauge needle as&#xD;
      compared to 23 gauge needle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      compare pain experience of trigger finger steroid injection between 26 gauge needle and 23&#xD;
      gauge needle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 30, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analog scale-pain</measure>
    <time_frame>one minute after injection</time_frame>
    <description>A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Trigger Finger</condition>
  <arm_group>
    <arm_group_label>26 gauge needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>23 gauge needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>26 gauge needle</intervention_name>
    <description>smaller gauge needle</description>
    <arm_group_label>26 gauge needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>23 gauge needle</intervention_name>
    <description>control group</description>
    <arm_group_label>23 gauge needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 year old&#xD;
&#xD;
          -  Male or female(non-pregnant)&#xD;
&#xD;
          -  Single trigger finger&#xD;
&#xD;
          -  Clinically diagnosed trigger finger- Green classification Grade I or II&#xD;
&#xD;
          -  No prior surgery to the involved finger&#xD;
&#xD;
          -  Subject is able to provide voluntary, written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 year old&#xD;
&#xD;
          -  Allergy to lignocaine or corticosteroid&#xD;
&#xD;
          -  Trigger finger with Green classification grade III or IV&#xD;
&#xD;
          -  Previous surgery on the affected finger&#xD;
&#xD;
          -  Any wound, neurovascular injury, or skin disease at injection site&#xD;
&#xD;
          -  Concomitant ipsilateral fingers/wrist/forearm/arm injury&#xD;
&#xD;
          -  Preexisting congenital/acquired deformities of hand (such as rheumatoid arthritis,&#xD;
             contracture)&#xD;
&#xD;
          -  Insensate hand&#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>Chuah Sion Keat</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Chuah Sion Keat</last_name>
    <phone>+617-3818580</phone>
    <email>cskeat@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chuah Sion Keat</name>
      <address>
        <city>Cheras</city>
        <state>Kuala Lumpur</state>
        <zip>56000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHUAH S KEAT</last_name>
      <phone>173818580</phone>
      <email>cskeat@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Malaysia</investigator_affiliation>
    <investigator_full_name>CHUAH SION KEAT</investigator_full_name>
    <investigator_title>medical officer</investigator_title>
  </responsible_party>
  <keyword>steroid injection</keyword>
  <keyword>pain</keyword>
  <keyword>needle gauge</keyword>
  <keyword>trigger finger</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigger Finger Disorder</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/NCT03790969
org study id: JEP-2018-654
nct id: NCT03790969
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To study the pain experience of trigger finger steroid injection with 26 gauge needle as
      compared to 23 gauge needle.
compare pain experience of trigger finger steroid injection between 26 gauge needle and 23
      gauge needle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Visual analog scale-pain
time frame: one minute after injection
description: A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain
arm group label: 26 gauge needle
arm group type: Experimental
description: intervention group
arm group label: 23 gauge needle
arm group type: Active Comparator
description: control group
intervention type: Device
intervention name: 26 gauge needle
description: smaller gauge needle
arm group label: 26 gauge needle
intervention type: Device
intervention name: 23 gauge needle
description: control group
arm group label: 23 gauge needle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chuah Sion Keat
role: Principal Investigator
last name: Chuah Sion Keat
phone: +617-3818580
email: cskeat@hotmail.com
facility: 
status: Recruiting
contact: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: National University of Malaysia
investigator full name: CHUAH SION KEAT
investigator title: medical officer
mesh term: Trigger Finger Disorder
sharing ipd: No