<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/NCT02974023</url>
  </required_header>
  <id_info>
    <org_study_id>PE/PAINGEAR/09/2016</org_study_id>
    <nct_id>NCT02974023</nct_id>
  </id_info>
  <brief_title>Efficacy of &quot;Pain Gear&quot; in Patients With Chronic Musculoskeletal Pain</brief_title>
  <official_title>Efficacy of &quot;Pain Gear&quot; in Patients With Chronic Musculoskeletal Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PharmEvo Pvt Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioElectronics Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>PharmEvo Pvt Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study was designed to evaluate the effectiveness and safety of the device in the&#xD;
      common areas of the body affected by different causes of musculoskeletal pain in Vietnamese&#xD;
      population in real life situation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as&#xD;
      an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low&#xD;
      power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The&#xD;
      device does not produce heat or any sensation. There are two basic requirements to use the&#xD;
      device, switching it on via an on/off switch, and affixing the device over the target area of&#xD;
      the body. The area of treatment is confined to the area within the 11.5-cm diameter loop&#xD;
      antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be&#xD;
      shaped to fit the area/location being treated as required. The device can be used up to 24 h&#xD;
      per day and is placed over the area of localized pain either using medical tape or a&#xD;
      specifically designed wrap.&#xD;
&#xD;
      In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic&#xD;
      evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual&#xD;
      analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in&#xD;
      60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and&#xD;
      Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with&#xD;
      placebo. Additionally, pain tolerance and physical health improved in PainGear -treated&#xD;
      patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic&#xD;
      therapy. No adverse events were detected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not started due to the Regulatory and administrative issues of Universities in Vietnam&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To assess difference in subjective pain with the use of PainGear for 2 weeks.</measure>
    <time_frame>2 weeks</time_frame>
    <description>[ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To record change in frequency of other analgesic modalities utilization</measure>
    <time_frame>2 weeks period</time_frame>
    <description>[ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)</measure>
    <time_frame>2 weeks, recorded on 1st and 14th day</time_frame>
    <description>[ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess patients satisfaction with two weeks therapy of PainGear</measure>
    <time_frame>14th day</time_frame>
    <description>[Time Frame: 14th day]</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Musculoskeletal Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pain Gear</intervention_name>
    <description>PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculo¬skeletal pain.</description>
    <other_name>ActiPatch</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from Low back pain and arthritis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic musculoskeletal pain of more than 6 month duration&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial.&#xD;
&#xD;
          -  In the Investigator's opinion, is able and willing to comply with all trial&#xD;
             requirements.&#xD;
&#xD;
          -  Male or female ages 18-80 years old&#xD;
&#xD;
          -  A current VAS pain rating ≥5/10&#xD;
&#xD;
          -  Able to complete and tolerate treatment for the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Woman&#xD;
&#xD;
          -  Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal&#xD;
             stimulators or other implanted electronic devices.&#xD;
&#xD;
          -  Patients using personal home based electrical stimulation devices&#xD;
&#xD;
          -  Active psychiatric disorders (as evidenced by use of antipsychotic or medication).&#xD;
&#xD;
          -  Patients diagnosed with history of significant mood disorder will be excluded&#xD;
             (depression or anxiety with adequate control would be acceptable).&#xD;
&#xD;
          -  Scheduled elective surgery or other procedures requiring general anesthesia during the&#xD;
             trial.&#xD;
&#xD;
          -  Participant with life expectancy of less than 6 months, or inappropriate for placebo&#xD;
             medication.&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the trial, or may&#xD;
             influence the result of the trial, or the participant's ability to participate in the&#xD;
             trial.&#xD;
&#xD;
          -  Participants who are not able to understand verbal or written English, and for whom&#xD;
             adequate translation/interpretation cannot be readily obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02974023
org study id: PE/PAINGEAR/09/2016
nct id: NCT02974023
lead sponsor: 
collaborator: 
has dmc: Yes
The current study was designed to evaluate the effectiveness and safety of the device in the
      common areas of the body affected by different causes of musculoskeletal pain in Vietnamese
      population in real life situation.
PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as
      an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low
      power, easy to use, pulsed shortwave therapy device for localized musculoskeletal pain. The
      device does not produce heat or any sensation. There are two basic requirements to use the
      device, switching it on via an on/off switch, and affixing the device over the target area of
      the body. The area of treatment is confined to the area within the 11.5-cm diameter loop
      antenna covering an area of 100 cm2, the antennae is circular, soft and flexible and can be
      shaped to fit the area/location being treated as required. The device can be used up to 24 h
      per day and is placed over the area of localized pain either using medical tape or a
      specifically designed wrap.

      In a randomized, double-blind, placebo-controlled clinical trial, patients with radiographic
      evidence of knee OA (osteoarthritis) and persistent pain higher than 40mm on the visual
      analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in
      60 knee OA patients. After 1 month, PainGear induced a significant reduction in VAS pain and
      Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores compared with
      placebo. Additionally, pain tolerance and physical health improved in PainGear -treated
      patients. Twenty-six per cent of patients in the PainGear group stopped NSAID/analgesic
      therapy. No adverse events were detected.
observational model: Other
time perspective: Prospective
measure: To assess difference in subjective pain with the use of PainGear for 2 weeks.
time frame: 2 weeks
description: [ Time Frame: Change from baseline visual analogue score over the course of 2 weeks]
measure: To record change in frequency of other analgesic modalities utilization
time frame: 2 weeks period
description: [ Time Frame: Change from baseline analgesic modalities usage over the course of 2 weeks period, to be recorded in modalities chart]
measure: To assess difference in Pain-related disability, indexed by the Oswestry Disability Index (ODI)
time frame: 2 weeks, recorded on 1st and 14th day
description: [ Time Frame: Change from baseline ODI score at 2 weeks, recorded on 1st and 14th day ]
measure: To assess patients satisfaction with two weeks therapy of PainGear
time frame: 14th day
description: [Time Frame: 14th day]
intervention type: Device
intervention name: Pain Gear
description: PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculo¬skeletal pain.
other name: ActiPatch
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Musculoskeletal Diseases