<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/NCT03240146</url>
  </required_header>
  <id_info>
    <org_study_id>SAIRB-17-0057</org_study_id>
    <nct_id>NCT03240146</nct_id>
  </id_info>
  <brief_title>Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain</brief_title>
  <acronym>PSWT</acronym>
  <official_title>Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioElectronics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioElectronics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has&#xD;
      FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of&#xD;
      the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high&#xD;
      frequency is reported to alleviate pain with no sensation. By randomising patients between&#xD;
      application of an active device or a dummy device and assessment of disability and pain&#xD;
      scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a&#xD;
      major health problem and if effective this has major economic implications as the device is&#xD;
      cheap and safe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic low back pain is a major public heath challenge for a number of reasons including&#xD;
      prevalence, seriousness, vulnerable populations, the utility of population health strategies,&#xD;
      and the importance of prevention at both the population and individual levels. Its incidence&#xD;
      and prevalence are increasing with an aging population and the rise in obesity. When&#xD;
      considering the location of chronic pain and its aetiology, back pain was the most common&#xD;
      location with arthritis/osteoarthritis being the most common cause. Chronic low back back&#xD;
      pain is costly to nations-not just in terms of health care expenditures and disability&#xD;
      compensation but also in terms of lost school days, lost productivity and employment, reduced&#xD;
      incomes, and lost potential and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">December 21, 2017</completion_date>
  <primary_completion_date type="Actual">December 21, 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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Devices will be coded, the placebo device is Identical to the active device in all ways except emitting the electromagnetic field. The energy emitted causes no sensation so can not be unmasked by user.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quality of life measure for chronic lower back pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Pain score</measure>
    <time_frame>4 weeks</time_frame>
    <description>assessment of pain being experienced</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Pain and Sleep Questionnaire three-item index</measure>
    <time_frame>4 weeks</time_frame>
    <description>Assessment of the impact of pain on the subjects sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Medication use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Quantify the use of analgesic medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will receive an active pulsed shortwave therapy device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed Shortwave Therapy</intervention_name>
    <description>Pulsed Shortwave Therapy device</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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 or above with stable chronic lower back pain&#xD;
&#xD;
          -  Females of childbearing must be on birth control or practice abstinence during the&#xD;
             study period&#xD;
&#xD;
             o Women of childbearing age will be screened with a urine pregnancy test. Women of&#xD;
             childbearing potential are defined as any female who has experienced menarche and who&#xD;
             is not permanently sterile or postmenopausal. Postmenopausal is defined as 12&#xD;
             consecutive months with no menses without an alternative medical cause.&#xD;
&#xD;
          -  ≥3 months duration of chronic low back pain&#xD;
&#xD;
          -  a current VAS pain rating ≥5/10&#xD;
&#xD;
          -  no radiating pain below the knee&#xD;
&#xD;
          -  Most of the pain in the body is present in the lower back or buttock, NOT in the lower&#xD;
             extremities, as determined during screening by the principal investigator. The&#xD;
             investigator will verbally ask the participant if most of the pain being experienced&#xD;
             is in the lower back/buttock area, and rely on the response for inclusion into the&#xD;
             study.&#xD;
&#xD;
          -  able to complete and tolerate treatment for the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female participant who is pregnant.&#xD;
&#xD;
          -  Significant renal or hepatic impairment confirmed by medical history.&#xD;
&#xD;
          -  Prior home use of pulsed shortwave therapy.&#xD;
&#xD;
          -  Prior history of spinal fusion or failed spinal surgery syndrome.&#xD;
&#xD;
          -  Laminectomy, laminotomy or discectomy within 12 months of enrollment.&#xD;
&#xD;
          -  Diagnostic or interventional injections or any low back surgeries not mentioned above,&#xD;
             including radiofrequency neuroablation within 6 months of enrollment.&#xD;
&#xD;
          -  The addition of strong opiates (hydrocodone, oxycodone, morphine), pregabalin and&#xD;
             gabapentin to the treatment regime during the course of the trial&#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 are excluded&#xD;
&#xD;
          -  Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in&#xD;
             the opinion of the investigator, would preclude successful patient participation will&#xD;
             also be excluded&#xD;
&#xD;
          -  Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication,&#xD;
             bipolar disorder, schizophrenia).&#xD;
&#xD;
          -  Patients diagnosed with history of significant mood disorder will be excluded (e.g.,&#xD;
             depression or anxiety with adequate control would be acceptable).&#xD;
&#xD;
          -  Scheduled elective surgery or other procedures requiring general anaesthesia during&#xD;
             the trial.&#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 have participated in another research trial involving an&#xD;
             investigational product in the past 12 weeks.&#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>Chandra Koneru, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Alabama Primary Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sree Koneru, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>BioElectronics Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ian Rawe, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>BioElectronics Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Alabama Primary Care</name>
      <address>
        <city>Athens</city>
        <state>Alabama</state>
        <zip>35611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 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>Back Pain</mesh_term>
    <mesh_term>Low 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/NCT03240146
org study id: SAIRB-17-0057
nct id: NCT03240146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has
      FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of
      the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high
      frequency is reported to alleviate pain with no sensation. By randomising patients between
      application of an active device or a dummy device and assessment of disability and pain
      scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a
      major health problem and if effective this has major economic implications as the device is
      cheap and safe.
Chronic low back pain is a major public heath challenge for a number of reasons including
      prevalence, seriousness, vulnerable populations, the utility of population health strategies,
      and the importance of prevention at both the population and individual levels. Its incidence
      and prevalence are increasing with an aging population and the rise in obesity. When
      considering the location of chronic pain and its aetiology, back pain was the most common
      location with arthritis/osteoarthritis being the most common cause. Chronic low back back
      pain is costly to nations-not just in terms of health care expenditures and disability
      compensation but also in terms of lost school days, lost productivity and employment, reduced
      incomes, and lost potential and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Devices will be coded, the placebo device is Identical to the active device in all ways except emitting the electromagnetic field. The energy emitted causes no sensation so can not be unmasked by user.
measure: Oswestry Disability Index
time frame: 4 weeks
description: Quality of life measure for chronic lower back pain
measure: Visual Analogue Pain score
time frame: 4 weeks
description: assessment of pain being experienced
measure: The Pain and Sleep Questionnaire three-item index
time frame: 4 weeks
description: Assessment of the impact of pain on the subjects sleep
measure: Analgesic Medication use
time frame: 4 weeks
description: Quantify the use of analgesic medications
arm group label: Study Group
arm group type: Active Comparator
description: Subjects in this group will receive an active pulsed shortwave therapy device.
arm group label: Control Group
arm group type: Placebo Comparator
description: Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.
intervention type: Device
intervention name: Pulsed Shortwave Therapy
description: Pulsed Shortwave Therapy device
arm group label: Control Group
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chandra Koneru, MD
role: Principal Investigator
affiliation: North Alabama Primary Care
last name: Sree Koneru, Ph.D
role: Study Director
affiliation: BioElectronics Corporation
last name: Ian Rawe, Ph.D.
role: Study Chair
affiliation: BioElectronics Corporation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No