<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/NCT03287570</url>
  </required_header>
  <id_info>
    <org_study_id>DUBH2017-0002</org_study_id>
    <nct_id>NCT03287570</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Cettum for Knee Osteoarthritis</brief_title>
  <official_title>Clinical Research on the Efficacy and Safety of Cettum on Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eun Jung Kim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DongGuk 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>
      The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion)&#xD;
      for patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigator targets the patients with knee osteoarthritis. After treatment in 3 groups -&#xD;
      Cettum treatment, traditional indirect moxibustion treatment, and usual care groups - the&#xD;
      investigators will compare the effects of pain relieving and daily performing improvement. So&#xD;
      the investigators will confirm the efficacy of Cettum, and further the best treatment method.&#xD;
      In addition, the investigators are going to evaluate the safety of abnormal reaction during&#xD;
      the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain NRS (Numeric Rating Scale) change</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Numeric Rating Scale is a unidimensional measure of pain intensity. The 11-point numeric scale ranges from '0' representing 'no pain' to '10' representing 'worst pain imaginable'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>100mm Pain VAS (Visual Analogue Scale)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The patient is asked to indicate their perceived pain intensity along a 100mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WOMAC (Western Ontario and McMaster Universities) total</measure>
    <time_frame>6 weeks</time_frame>
    <description>WOMAC scale is widely used to evaluate the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the joints. The WOMAC scale measures 5 items for pain, 2 for stiffness, and 17 for functional limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGA (Patient Global Assessment)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The patient may choose to answer the question of how much better the symptom has improved compared to the previous treatment: Very good, Good, Fair, Poor, Very poor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature sense threshold</measure>
    <time_frame>6 weeks</time_frame>
    <description>Investigator attaches the temperature sensor to the measurement area and increase or decrease the temperature by starting with reference temperature. Warm pain threshold and heat pain threshold are recorded to compare the difference between the value at baseline and the value at the end of the treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>6 weeks</time_frame>
    <description>Any unpredicted symptoms are checked at each visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">138</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Cettum (Electric moxibustion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group receive Cettum (Electric moxibustion) treatment prescribed by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional indirect moxibustion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this group receive traditional indirect moxibustion treatment using the same points, applied by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients in this group maintain the usual treatment and self-care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cettum</intervention_name>
    <description>The treatment is applied twice a week for 15 minutes for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Electric moxibustion, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea) is used.</description>
    <arm_group_label>Cettum (Electric moxibustion)</arm_group_label>
    <other_name>Electric moxibustion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional indirect moxibustion</intervention_name>
    <description>The treatment is applied twice a week for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Traditional indirect moxibustion, Taekeukttum manufactured by Haenglim Seowon Medical Co.(China) is used. A total of three moxibustion cones are applied indirectly to each point per treatment session.</description>
    <arm_group_label>Traditional indirect moxibustion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>The patients in this group maintain the usual treatment and self-care.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 40 years of age, but below 70 years of age&#xD;
&#xD;
          2. Presence of knee osteoarthritis diagnosed according to American College of&#xD;
             Rheumatology classification criteria and satisfying the following 2 conditions&#xD;
&#xD;
               -  Knee pain when weight load in one or both knees in the last 6 months&#xD;
&#xD;
                    -  Knee pain rated &gt;4cm on a 10cm Visual Analog Scale (VAS)&#xD;
&#xD;
          3. Feeling temperature sense to distinguish temperature differences&#xD;
&#xD;
          4. An understanding of the objectives and methods of the clinical trial, and willingness&#xD;
             in completing the consent form&#xD;
&#xD;
          5. Those who are reliable and willing to cooperate in this test, and obey the&#xD;
             restrictions for the next 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Trauma to the knee(s) within 6 months prior to enrollment, causing pain or functional&#xD;
             problems&#xD;
&#xD;
          2. Surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional&#xD;
             problems&#xD;
&#xD;
          3. A history of intra-articular injection within the last 3 months&#xD;
&#xD;
          4. A physical or laboratory finding indicating presence of an inflammatory arthritis&#xD;
             (e.g. rheumatoid arthritis, autoimmune disease)&#xD;
&#xD;
          5. Presence of physical or psychiatric disorder that may affect moxibustion treatment&#xD;
&#xD;
          6. Presence of neurological disorder including paralysis symptoms on local or general&#xD;
             sensation&#xD;
&#xD;
          7. A female who is pregnant or is lactating&#xD;
&#xD;
          8. Being afraid of moxibustion treatment or expected to cause side effects&#xD;
&#xD;
          9. When researchers evaluate that it is not appropriate to participate in this clinical&#xD;
             test&#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>Eun Jung Kim, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>DongGuk University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dongguk University Ilsan Oriental Hospital</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10326</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Bundang Oriental Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>DongGuk University</investigator_affiliation>
    <investigator_full_name>Eun Jung Kim</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis, Knee</keyword>
  <keyword>Moxibustion</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03287570
org study id: DUBH2017-0002
nct id: NCT03287570
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is verify the efficacy and safety of Cettum (Electric moxibustion)
      for patients with knee osteoarthritis.
The investigator targets the patients with knee osteoarthritis. After treatment in 3 groups -
      Cettum treatment, traditional indirect moxibustion treatment, and usual care groups - the
      investigators will compare the effects of pain relieving and daily performing improvement. So
      the investigators will confirm the efficacy of Cettum, and further the best treatment method.
      In addition, the investigators are going to evaluate the safety of abnormal reaction during
      the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain NRS (Numeric Rating Scale) change
time frame: 6 weeks
description: The Numeric Rating Scale is a unidimensional measure of pain intensity. The 11-point numeric scale ranges from '0' representing 'no pain' to '10' representing 'worst pain imaginable'.
measure: 100mm Pain VAS (Visual Analogue Scale)
time frame: 6 weeks
description: The patient is asked to indicate their perceived pain intensity along a 100mm horizontal line, where '0' represents 'no pain' and '100', 'unbearable pain'.
measure: WOMAC (Western Ontario and McMaster Universities) total
time frame: 6 weeks
description: WOMAC scale is widely used to evaluate the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the joints. The WOMAC scale measures 5 items for pain, 2 for stiffness, and 17 for functional limitation.
measure: EQ-5D-5L (EuroQol 5-Dimensions 5-Levels)
time frame: 6 weeks
description: The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
measure: PGA (Patient Global Assessment)
time frame: 6 weeks
description: The patient may choose to answer the question of how much better the symptom has improved compared to the previous treatment: Very good, Good, Fair, Poor, Very poor.
measure: Temperature sense threshold
time frame: 6 weeks
description: Investigator attaches the temperature sensor to the measurement area and increase or decrease the temperature by starting with reference temperature. Warm pain threshold and heat pain threshold are recorded to compare the difference between the value at baseline and the value at the end of the treatment.
measure: Adverse Events
time frame: 6 weeks
description: Any unpredicted symptoms are checked at each visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.
arm group label: Cettum (Electric moxibustion)
arm group type: Experimental
description: The patients in this group receive Cettum (Electric moxibustion) treatment prescribed by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.
arm group label: Traditional indirect moxibustion
arm group type: Active Comparator
description: The patients in this group receive traditional indirect moxibustion treatment using the same points, applied by a certified Korean Medicine Doctor with more than 6 years of Oriental Medicine College education.
arm group label: Usual care
arm group type: Other
description: The patients in this group maintain the usual treatment and self-care.
intervention type: Device
intervention name: Cettum
description: The treatment is applied twice a week for 15 minutes for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Electric moxibustion, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea) is used.
arm group label: Cettum (Electric moxibustion)
other name: Electric moxibustion
intervention type: Procedure
intervention name: Traditional indirect moxibustion
description: The treatment is applied twice a week for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Traditional indirect moxibustion, Taekeukttum manufactured by Haenglim Seowon Medical Co.(China) is used. A total of three moxibustion cones are applied indirectly to each point per treatment session.
arm group label: Traditional indirect moxibustion
intervention type: Other
intervention name: Usual care
description: The patients in this group maintain the usual treatment and self-care.
arm group label: Usual care
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Eun Jung Kim, Ph. D.
role: Principal Investigator
affiliation: DongGuk University
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: DongGuk University
investigator full name: Eun Jung Kim
investigator title: Principle Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Undecided