<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/NCT03238183</url>
  </required_header>
  <id_info>
    <org_study_id>MOST 106-2314-B-341-003</org_study_id>
    <nct_id>NCT03238183</nct_id>
  </id_info>
  <brief_title>Effects of Dextrose on Knee Osteoarthritis</brief_title>
  <official_title>Additional Therapeutic Effects of Dextrose to Hyaluronic Acid on Knee Osteoarthritis: a Double Blind, Randomized-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</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>
      Using double blind, randomized controlled design to study the immediate, short-term and&#xD;
      intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and&#xD;
      hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 106 patients will be collected. The participants will be randomized into two&#xD;
      groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.&#xD;
&#xD;
      The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three&#xD;
      weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid&#xD;
      combined dextrose injection per week in three weeks.&#xD;
&#xD;
      The pain, physical activity, and functional performance will be evaluated.&#xD;
&#xD;
      All the evaluations will be re-evaluated at one week after injection, one month after&#xD;
      injection, three months after injection, and six month after injection.&#xD;
&#xD;
      Subjects and the evaluator will be both blinded to the group's classification during the&#xD;
      whole course of study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>physical activity-on level walking time</measure>
    <time_frame>changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection</time_frame>
    <description>10 meter walking</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physical activity-stair climbing time</measure>
    <time_frame>changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection</time_frame>
    <description>stairs climbing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physical activity-chair rising time</measure>
    <time_frame>changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection</time_frame>
    <description>chair rising</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional performance</measure>
    <time_frame>changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection</time_frame>
    <description>Western Ontario and McMaster Universities Osteoarthritis index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection</time_frame>
    <description>Knee Injury and Osteoarthritis Outcome Score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">106</enrollment>
  <condition>Physical Activity</condition>
  <condition>Functional Disturbance</condition>
  <arm_group>
    <arm_group_label>hyaluronic acid combined dextrose group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hyaluronic acid group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dextrose</intervention_name>
    <description>compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis</description>
    <arm_group_label>hyaluronic acid combined dextrose group</arm_group_label>
    <other_name>glucose water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hyaluronic acid</intervention_name>
    <description>compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis</description>
    <arm_group_label>hyaluronic acid combined dextrose group</arm_group_label>
    <arm_group_label>hyaluronic acid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  knee osteoarthritis with Kellgren/Lawrence grade II or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who have neurological deficit, such as stroke who have implant in knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ru-Lan Hsieh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shin Kong Wu Ho-Su Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ru-Lan Hsieh</last_name>
    <phone>228332211</phone>
    <email>M001052@ms.skh.org.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ru-Lan Hsieh</last_name>
    <phone>228332211</phone>
    <email>rulan@tmu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shin Kong Wu Ho-Su Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>111-01</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Ru-Lan Hsieh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>knee osteoarthritis</keyword>
  <keyword>hyaluronic acid</keyword>
  <keyword>dextrose</keyword>
  <keyword>therapeutic effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_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/NCT03238183
org study id: MOST 106-2314-B-341-003
nct id: NCT03238183
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Using double blind, randomized controlled design to study the immediate, short-term and
      intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and
      hyaluronic acid combined dextrose injection to patients with knee osteoarthritis.
A total of 106 patients will be collected. The participants will be randomized into two
      groups, including hyaluronic acid group and hyaluronic acid combined dextrose group.

      The hyaluronic acid group will receive 3 times of hyaluronic acid injection per week in three
      weeks; the hyaluronic acid combined dextrose group will receive 3 times of hyaluronic acid
      combined dextrose injection per week in three weeks.

      The pain, physical activity, and functional performance will be evaluated.

      All the evaluations will be re-evaluated at one week after injection, one month after
      injection, three months after injection, and six month after injection.

      Subjects and the evaluator will be both blinded to the group's classification during the
      whole course of study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: physical activity-on level walking time
time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
description: 10 meter walking
measure: physical activity-stair climbing time
time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
description: stairs climbing
measure: physical activity-chair rising time
time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
description: chair rising
measure: functional performance
time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
description: Western Ontario and McMaster Universities Osteoarthritis index
measure: quality of life
time frame: changes from baseline to at one week after injection, one month after injection, three months after injection, and six month after injection
description: Knee Injury and Osteoarthritis Outcome Score
arm group label: hyaluronic acid combined dextrose group
arm group type: Active Comparator
description: Hyaluronic acid (2 cc) combined 25% dextrose (3.5 cc 50% dextrose plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
arm group label: hyaluronic acid group
arm group type: Placebo Comparator
description: Hyaluronic acid (2 cc) combined normal saline (3.5 cc normal saline plus 3.5 cc 2% lidocaine) injection: one injection per week, for 3 weeks, to compare the additional therapeutic effects of combined hyaluronic acid and dextrose injections to hyaluronic acid injections
intervention type: Drug
intervention name: dextrose
description: compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
arm group label: hyaluronic acid combined dextrose group
other name: glucose water
intervention type: Device
intervention name: hyaluronic acid
description: compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
arm group label: hyaluronic acid combined dextrose group
arm group label: hyaluronic acid group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ru-Lan Hsieh
role: Principal Investigator
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
last name: Ru-Lan Hsieh
phone: 228332211
email: M001052@ms.skh.org.tw
last name: Ru-Lan Hsieh
phone: 228332211
email: rulan@tmu.edu.tw
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Ru-Lan Hsieh
investigator title: Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hyaluronic Acid
sharing ipd: No