<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/NCT02971592</url>
  </required_header>
  <id_info>
    <org_study_id>0047-16-ASM</org_study_id>
    <nct_id>NCT02971592</nct_id>
  </id_info>
  <brief_title>Estimation of Therapeutic Effect of MDcure on Patients With Chronic Lower Back Pain</brief_title>
  <acronym>E_MDcure_LBP</acronym>
  <official_title>Estimation of Therapeutic Effect of MDcure on Patients With Chronic Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assuta Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aerotel Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Assuta Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1&#xD;
      listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity&#xD;
      (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to&#xD;
      reduce muscular aches and pains particularly of the lower back.&#xD;
&#xD;
      assessing the reduction of lower back pain. Half of participants will receive the MDcure&#xD;
      device, while the other half will receive a mock device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in pain in experiment group</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in pain in placebo group</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess period of time to attain improvement</measure>
    <time_frame>maximum of 6 weeks</time_frame>
    <description>Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Back Pain Lower Back Chronic</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MDcure</intervention_name>
    <description>reception of real working MDcure - device that does apply the electromagnetic field</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mock Device</intervention_name>
    <description>reception of device that does not apply the electromagnetic field</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18-75&#xD;
&#xD;
          -  Patients with chronic lower back for more then 3 month&#xD;
&#xD;
          -  Patients who scored over 21% and below 60% in the Oswestry questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A neurological deficient in lower limbs&#xD;
&#xD;
          -  Patients who scored more than 60% on the Oswestry questionnaire.&#xD;
&#xD;
          -  Patients who underwent surgical intervention in spine including metal implant in lower&#xD;
             back&#xD;
&#xD;
          -  Patients diagnosed with cancer&#xD;
&#xD;
          -  Patients with any type of vertebral fracture&#xD;
&#xD;
          -  Patients who received steroid injection less then a month prior to starting the&#xD;
             experiment&#xD;
&#xD;
          -  Patients treated with steroids as a preventive treatment on a regular basis&#xD;
&#xD;
          -  Patients using narcotic drugs for over a six month period or cannabis or any other&#xD;
             sort of narcotic drug for over a six month period prior to their enrollment in the&#xD;
             study&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Or Harel</last_name>
    <phone>0097237645282</phone>
    <email>orh@assuta.co.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mickey Scheinowitz, Prof.</last_name>
    <email>mickeys@aerotel.co.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assuta Medical Centers - Ramat Hahyal</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Or Harel</last_name>
      <phone>0097237645282</phone>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assuta Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Eran Segal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</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/NCT02971592
org study id: 0047-16-ASM
nct id: NCT02971592
lead sponsor: 
collaborator: 
has dmc: No
This study will assess the therapeutic effect of MDcure® device. MDcure® is an FDA Class 1
      listed medical device, produced to ISO-13485 standards, that delivers extremely low intensity
      (nano Tesla; 10-9) and low frequencies (1-100 Hertz) electromagnetic fields (EMF) intended to
      reduce muscular aches and pains particularly of the lower back.

      assessing the reduction of lower back pain. Half of participants will receive the MDcure
      device, while the other half will receive a mock device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Improvement in pain in experiment group
time frame: 6 weeks
description: Assessment of rate of patients from the experiment group who report improvement in pain above 20% in Oswestry scale
measure: Improvement in pain in placebo group
time frame: 6 weeks
description: Assessment of rate of patients from the placebo group who report improvement in pain above 20% in Oswestry scale
measure: Assess period of time to attain improvement
time frame: maximum of 6 weeks
description: Assess the duration period of improvement, starting from the beginning of the experiment up to the point where 20% improvement is attained
arm group label: Experimental
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Device
intervention name: MDcure
description: reception of real working MDcure - device that does apply the electromagnetic field
arm group label: Experimental
intervention type: Other
intervention name: Mock Device
description: reception of device that does not apply the electromagnetic field
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Or Harel
phone: 0097237645282
email: orh@assuta.co.il
last name: Mickey Scheinowitz, Prof.
email: mickeys@aerotel.co.il
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Assuta Medical Center
investigator full name: Dr. Eran Segal
investigator title: Principal Investigator
mesh term: Back Pain
sharing ipd: No