<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/NCT04406337</url>
  </required_header>
  <id_info>
    <org_study_id>PMR</org_study_id>
    <nct_id>NCT04406337</nct_id>
  </id_info>
  <brief_title>Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis</brief_title>
  <official_title>A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Health and Sports, Myanmar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Medicine (1), Yangon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Physical Medicine and Rehabilitation, Yangon General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ministry of Health and Sports, Myanmar</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>
      To compare the effects of low intensity pulsed ultrasound with high intensity continuous&#xD;
      ultrasound in knee osteoarthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Knee osteoarthritis is a common disorder affecting elderly and obese. Currently, there are 3&#xD;
      types of treatment; pharmacological, non-pharmacological and surgery. Though ultrasound, a&#xD;
      non-pharmacological treatment, is increasingly used in knee osteoarthritis, the advantages&#xD;
      and disadvantages of low intensity pulsed ultrasound (LIPUS) and high intensity continuous&#xD;
      ultrasound (HICUS) are yet to be clarified. Therefore, a randomized control trial will be&#xD;
      done to compare LIPUS and HICUS in participants with knee osteoarthritis presenting to&#xD;
      Department of Physical Medicine and Rehabilitation, Yangon General Hospital, Myanmar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>It is one of the most commonly used measures of pain intensity and it is divided into 10 ordinal ratings with 0 being &quot;no pain&quot; and 10 being &quot;pain as bad as it could be&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)</measure>
    <time_frame>8 weeks</time_frame>
    <description>This index measures clinically important symptoms of pain, stiffness and function. It consists of 23 questions (5 pain, 2 stiffness and 16 physical function) and the maximum score is 100, indicating the worst outcome while the minimum score is 0, indicating the best outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with skin irritation</measure>
    <time_frame>8 weeks</time_frame>
    <description>Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with tingling</measure>
    <time_frame>8 weeks</time_frame>
    <description>Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with oedema</measure>
    <time_frame>8 weeks</time_frame>
    <description>Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with burns</measure>
    <time_frame>8 weeks</time_frame>
    <description>Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis</condition>
  <condition>Rheumatic Diseases</condition>
  <condition>Musculoskeletal Diseases</condition>
  <arm_group>
    <arm_group_label>Low intensity pulsed ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive low intensity pulsed ultrasound therapy on the affected knees for 20 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High intensity continuous ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm will receive high intensity continuous ultrasound therapy on the affected knees for 10 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low intensity pulsed ultrasound</intervention_name>
    <description>Low intensity pulsed ultrasound therapy will use ultrasound with frequency of 1.5 MHz, power intensity of 30 mW/cm^2 (0.03 W/cm^2 ) and 20% duty cycle.</description>
    <arm_group_label>Low intensity pulsed ultrasound</arm_group_label>
    <other_name>Osteotron IV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High intensity continuous ultrasound</intervention_name>
    <description>High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.</description>
    <arm_group_label>High intensity continuous ultrasound</arm_group_label>
    <other_name>US 50 (Medical Italia)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with knee pain (VAS 3 to 6)&#xD;
&#xD;
          -  Kellgren and Lawrence grade 2 and 3 in X' ray knee joint&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis, Gouty arthritis, Spondyloarthropathies, Metabolic arthropathies&#xD;
&#xD;
          -  Infection of knee joint&#xD;
&#xD;
          -  Tumor of knee joint&#xD;
&#xD;
          -  History of hypersensitivity to heat&#xD;
&#xD;
          -  Previous knee surgery in affected side&#xD;
&#xD;
          -  Intra-articular injection within previous 3 months&#xD;
&#xD;
          -  Participants taking treatment with other physical modalities such as low-level laser&#xD;
             therapy and Trans Cutaneous Electrical Nerve Stimulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khin Myo Hla, PhD M.B.,B.S</last_name>
    <role>Study Chair</role>
    <affiliation>Physical Medicine and Rehabilitation Department, Yangon General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Soe Soe Khaing, PhD M.B.,B.S</last_name>
    <role>Study Director</role>
    <affiliation>Physical Medicine and Rehabilitation Department, Yangon General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wunn Lei Thwe, M.B.,B.S</last_name>
    <phone>+959786478599</phone>
    <email>wunnleithwe92@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Physical Medicine and Rehabilitation, Yangon General Hospital</name>
      <address>
        <city>Yangon</city>
        <country>Myanmar</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wunn Lei Thwe, M.B.,B.S</last_name>
      <phone>+959786478599</phone>
      <email>wunnleithwe92@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Myanmar</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health and Sports, Myanmar</investigator_affiliation>
    <investigator_full_name>Wunn Lei Thwe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Low intensity pulsed ultrasound (LIPUS)</keyword>
  <keyword>High intensity continuous ultrasound</keyword>
  <keyword>Knee pain</keyword>
  <keyword>Knee stiffness</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Myanmar</keyword>
  <keyword>Osteotron</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>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT04406337
org study id: PMR
nct id: NCT04406337
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the effects of low intensity pulsed ultrasound with high intensity continuous
      ultrasound in knee osteoarthritis
Knee osteoarthritis is a common disorder affecting elderly and obese. Currently, there are 3
      types of treatment; pharmacological, non-pharmacological and surgery. Though ultrasound, a
      non-pharmacological treatment, is increasingly used in knee osteoarthritis, the advantages
      and disadvantages of low intensity pulsed ultrasound (LIPUS) and high intensity continuous
      ultrasound (HICUS) are yet to be clarified. Therefore, a randomized control trial will be
      done to compare LIPUS and HICUS in participants with knee osteoarthritis presenting to
      Department of Physical Medicine and Rehabilitation, Yangon General Hospital, Myanmar.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analog Scale (VAS)
time frame: 8 weeks
description: It is one of the most commonly used measures of pain intensity and it is divided into 10 ordinal ratings with 0 being "no pain" and 10 being "pain as bad as it could be".
measure: Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)
time frame: 8 weeks
description: This index measures clinically important symptoms of pain, stiffness and function. It consists of 23 questions (5 pain, 2 stiffness and 16 physical function) and the maximum score is 100, indicating the worst outcome while the minimum score is 0, indicating the best outcome.
measure: Percentage of participants with skin irritation
time frame: 8 weeks
description: Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
measure: Percentage of participants with tingling
time frame: 8 weeks
description: Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
measure: Percentage of participants with oedema
time frame: 8 weeks
description: Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
measure: Percentage of participants with burns
time frame: 8 weeks
description: Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
arm group label: Low intensity pulsed ultrasound
arm group type: Experimental
description: Participants in this arm will receive low intensity pulsed ultrasound therapy on the affected knees for 20 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given.
arm group label: High intensity continuous ultrasound
arm group type: Active Comparator
description: Participants in this arm will receive high intensity continuous ultrasound therapy on the affected knees for 10 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given.
intervention type: Device
intervention name: Low intensity pulsed ultrasound
description: Low intensity pulsed ultrasound therapy will use ultrasound with frequency of 1.5 MHz, power intensity of 30 mW/cm^2 (0.03 W/cm^2 ) and 20% duty cycle.
arm group label: Low intensity pulsed ultrasound
other name: Osteotron IV
intervention type: Device
intervention name: High intensity continuous ultrasound
description: High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.
arm group label: High intensity continuous ultrasound
other name: US 50 (Medical Italia)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Khin Myo Hla, PhD M.B.,B.S
role: Study Chair
affiliation: Physical Medicine and Rehabilitation Department, Yangon General Hospital
last name: Soe Soe Khaing, PhD M.B.,B.S
role: Study Director
affiliation: Physical Medicine and Rehabilitation Department, Yangon General Hospital
last name: Wunn Lei Thwe, M.B.,B.S
phone: +959786478599
email: wunnleithwe92@gmail.com
facility: 
status: Recruiting
contact: 
country: Myanmar
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health and Sports, Myanmar
investigator full name: Wunn Lei Thwe
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Rheumatic Diseases
mesh term: Musculoskeletal Diseases
mesh term: Collagen Diseases
sharing ipd: No