<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/NCT02975154</url>
  </required_header>
  <id_info>
    <org_study_id>MicrocurrencyOA</org_study_id>
    <nct_id>NCT02975154</nct_id>
  </id_info>
  <brief_title>Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee</brief_title>
  <official_title>Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal Ministry for Economic Affairs and Energy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of&#xD;
      the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive&#xD;
      Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment&#xD;
      with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control&#xD;
      group without specific interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this randomized, controlled pilot study is to evaluate the effect of&#xD;
      Microcurrent therapy on pain and physical function in patients with osteoarthritis of the&#xD;
      knee. The secondary objective is to compare the effects of different currents. Patients will&#xD;
      be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but&#xD;
      different currents will be used. Group 3 will receive treatment with the Microcurrent&#xD;
      treatment apparatus, but without any current. Group 4 will be a control group without&#xD;
      specific intervention.&#xD;
&#xD;
      Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks.&#xD;
      Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of&#xD;
      treatment (T1), at the end of treatment (T2) and three months after the end of treatment&#xD;
      (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days&#xD;
      after T1), and at T3 (three months after T2). Patients will be recruited based on the records&#xD;
      of the clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">September 4, 2017</completion_date>
  <primary_completion_date type="Actual">September 4, 2017</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Ratings scale (NRS) for pain (0-10)</measure>
    <time_frame>Change of NRS: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>numerical Rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee injury and Osteoarthritis Outcome Score</measure>
    <time_frame>Change of scores: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>Knee specific Instrument measuring pan, function and Quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 36</measure>
    <time_frame>Change of scores: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>Generic HRQOL measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Treatment (Questionnaire)</measure>
    <time_frame>Evaluation at the end of treatment (in average 21 days after Start of treatment)</time_frame>
    <description>Self-administered questionnaire that was developed for this study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion knee joint</measure>
    <time_frame>Change: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>Clinical test with goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Get-up-and-Go-Test (GUG)</measure>
    <time_frame>Change: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>clinical test that measures mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walking test</measure>
    <time_frame>Change: Before treatment vs. end of treatment (in average 21 days later)</time_frame>
    <description>Clinical test that measures the Walking ability</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>Microcurrent therapy, type A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10.&#xD;
Previous treatments will be continued.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microcurrent therapy, type B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Microcurrent therapy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Intervention. Previous treatments will be continued.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microcurrent therapy</intervention_name>
    <description>The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.</description>
    <arm_group_label>Microcurrent therapy, type A</arm_group_label>
    <arm_group_label>Microcurrent therapy, type B</arm_group_label>
    <arm_group_label>Sham Microcurrent therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  osteoarthritis of the knee&#xD;
&#xD;
          -  pain intensity &gt; 3 on the numerical rating scale (0-10)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  knee arthroplasty&#xD;
&#xD;
          -  gravity&#xD;
&#xD;
          -  dermal Irritation at the skin of the knee&#xD;
&#xD;
          -  carcinoma&#xD;
&#xD;
          -  known osteoarthritis grade 4 (Kellgren and Lawrence score)&#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>Martin B Weigl</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>PD Dr. Martin Weigl, MPH</investigator_full_name>
    <investigator_title>PD, MD, MPH (Harvard University)</investigator_title>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <keyword>microcurrent</keyword>
  <keyword>knee</keyword>
  <keyword>electrotherapy</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>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/NCT02975154
org study id: MicrocurrencyOA
nct id: NCT02975154
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of
      the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive
      Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment
      with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control
      group without specific interventions.
The objective of this randomized, controlled pilot study is to evaluate the effect of
      Microcurrent therapy on pain and physical function in patients with osteoarthritis of the
      knee. The secondary objective is to compare the effects of different currents. Patients will
      be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but
      different currents will be used. Group 3 will receive treatment with the Microcurrent
      treatment apparatus, but without any current. Group 4 will be a control group without
      specific intervention.

      Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks.
      Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of
      treatment (T1), at the end of treatment (T2) and three months after the end of treatment
      (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days
      after T1), and at T3 (three months after T2). Patients will be recruited based on the records
      of the clinic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Numerical Ratings scale (NRS) for pain (0-10)
time frame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
description: numerical Rating scale
measure: Knee injury and Osteoarthritis Outcome Score
time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
description: Knee specific Instrument measuring pan, function and Quality of life.
measure: Short-Form 36
time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
description: Generic HRQOL measure
measure: Satisfaction with Treatment (Questionnaire)
time frame: Evaluation at the end of treatment (in average 21 days after Start of treatment)
description: Self-administered questionnaire that was developed for this study
measure: Range of Motion knee joint
time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
description: Clinical test with goniometer
measure: Get-up-and-Go-Test (GUG)
time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
description: clinical test that measures mobility
measure: 6-minute walking test
time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
description: Clinical test that measures the Walking ability
arm group label: Microcurrent therapy, type A
arm group type: Active Comparator
description: Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10.
Previous treatments will be continued.
arm group label: Microcurrent therapy, type B
arm group type: Active Comparator
description: Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
arm group label: Sham Microcurrent therapy
arm group type: Sham Comparator
description: Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
arm group label: No Intervention
arm group type: No Intervention
description: No Intervention. Previous treatments will be continued.
intervention type: Device
intervention name: Microcurrent therapy
description: The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.
arm group label: Microcurrent therapy, type A
arm group label: Microcurrent therapy, type B
arm group label: Sham Microcurrent therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin B Weigl
role: Principal Investigator
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: PD Dr. Martin Weigl, MPH
investigator title: PD, MD, MPH (Harvard University)
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No