<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/NCT03828864</url>
  </required_header>
  <id_info>
    <org_study_id>X18-0425</org_study_id>
    <nct_id>NCT03828864</nct_id>
  </id_info>
  <brief_title>Pulsed Shortwave Therapy (ActiPatch®) Study in Chronic Low Back Pain</brief_title>
  <acronym>PSWT</acronym>
  <official_title>Pulsed Shortwave Therapy (PSWT) Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioElectronics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Prince Alfred Hospital, Sydney, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This study aims to test the efficacy of the ActiPatch® device by means of a randomized double&#xD;
      blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain&#xD;
      clinic. Outcome measures are validated psychometric measures evaluating known determinants of&#xD;
      pain related disability, functional capacity measures, and pain scores; and a bespoke&#xD;
      questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic&#xD;
      or other pain related medications with the future assistance of the ActiPatch®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to test the efficacy of the ActiPatch® device by means of a randomised double&#xD;
      blind controlled trial in a convenience sample of chronic low back pain patients at Royal&#xD;
      Prince Alfred Hospital (RPAH) pain clinic. Outcome measures are validated psychometric&#xD;
      measures evaluating known determinants of pain related disability, functional capacity&#xD;
      measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended&#xD;
      usage, and willingness to reduce analgesic or other pain related medications with the future&#xD;
      assistance of the ActiPatch®.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory (BPI) Short Form</measure>
    <time_frame>30 days</time_frame>
    <description>The BPI-SF is a questionnaire - self-administered or by interview - that assesses both pain intensity and pain interference in common aspects of one's life. It has reliability &amp; validity across cultural and language groups &amp; is one of the standard measures used by the national Electronic Persistent Pain Outcomes Collaboration (ePPOC) that collates data from various Pain Management Centres to evaluate outcomes in pain clinics Australia wide.&#xD;
Scoring&#xD;
Question answers are complied into two categories:&#xD;
Pain severity is 0 - 10, with 10 being worst pain possible&#xD;
Pain inference score is 0 - 10, with 10 being worst possible pain inference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central Sensitisation Inventory - short form (CSI-9)</measure>
    <time_frame>30 days</time_frame>
    <description>Central Sensitisation (CS) is thought to be one underlying mechanism for the prevalence of chronic pain and the ActiPatch® device is believed to reduce central sensitization. Use of the CSI-9 will be used to assess the extent to which central sensitization is present in the study cohort and if use of the device produces a change in CS. This will then allow appraisal of the role of central sensitization in any outcomes achieved.&#xD;
Scoring, scores are totaled from the assessment Five severity levels (subclinical = 0-29, mild = 30-39, moderate = 40-49, severe = 50-59, and severe = 60-100) central sensitization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance</measure>
    <time_frame>30 days</time_frame>
    <description>The interaction between sleep disturbance and chronic pain is widely reported in the literature, and is thought to be a two way interaction. Use of the PSQ-3 will be used to assess the extent to which perceived sleep disturbance is present in the study cohort and if use of the ActiPatch® device is associated with a change in sleep quality. Addressing sleep quality may help to treat chronic pain including LBP and thereby have clinical treatment applications.&#xD;
Scoring 0-30, 0 no sleep disturbance and 30 worst sleep disturbance Three visual analog scales of 0-10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Active Pulsed Shortwave therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Pulsed Shortwave therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed Shortwave Therapy</intervention_name>
    <description>Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day</description>
    <arm_group_label>Active Pulsed Shortwave therapy</arm_group_label>
    <other_name>ActiPatch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Pulsed Shortwave Therapy</intervention_name>
    <description>Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day</description>
    <arm_group_label>Placebo Pulsed Shortwave therapy</arm_group_label>
    <other_name>Placebo ActiPatch</other_name>
  </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;
          -  In the event of possible pre-existing pregnancy, women of childbearing age will be&#xD;
             screened with a urine pregnancy test. Women of childbearing potential are defined as&#xD;
             any female who has experienced menarche and who is not permanently sterile or&#xD;
             postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses&#xD;
             without an alternative medical cause.&#xD;
&#xD;
          -  ≥3 months duration of chronic low back pain i.e. cut off period for acute pain&#xD;
&#xD;
          -  a current BPI pain rating ≥5/10 on one of the 4 of the four pain VAS scales on the BPI&#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;
          -  Pain stable in one area of the low back- i.e. not variable in location&#xD;
&#xD;
          -  Medication regime stable over the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female participant who is pregnant.&#xD;
&#xD;
          -  Subjects using personal home based electrical stimulation devices&#xD;
&#xD;
          -  Prior home use of pulsed shortwave therapy. i.e ActiPatch®&#xD;
&#xD;
          -  Scheduled elective surgery or other procedures requiring general anaesthesia during&#xD;
             the trial.&#xD;
&#xD;
          -  Planned or scheduled variation in pain related medication (analgesic or psychoactive)&#xD;
             regime during the course of the trial.&#xD;
&#xD;
          -  Active psychiatric disorders (e.g. participants using antipsychotic medication, with&#xD;
             bipolar disorder or schizophrenia).&#xD;
&#xD;
          -  Subjects with other concomitant illnesses (e.g., malignancy) which, in the opinion of&#xD;
             the investigator, would preclude successful subject participation&#xD;
&#xD;
          -  Subjects diagnosed with a history of significant mood disorder will be excluded (Note&#xD;
             that subjects with depression or anxiety with adequate control would be acceptable).&#xD;
             Participants would be required to be stable with their moods (EPPOC data or&#xD;
             psychological or psychiatric evaluation can be referenced in the case of doubt)&#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;
&#xD;
          -  Participants who are planning to change any other variables during the study period&#xD;
             likely to affect their pain or function e.g. commencement of an exercise class;&#xD;
             ceasing allied health treatment&#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>Graeme Campbell</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Prince Alfred Hospital, Sydney, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arun Aggarwal, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Royal Prince Alfred Hospital, Sydney, Australia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Graeme Campbell</last_name>
    <phone>(02) 95159016</phone>
    <email>graeme.campbell1@health.nsw.gov.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arun Aggarwal, Prof</last_name>
    <phone>02 9515 9870</phone>
    <email>arun.a@sydney.edu.au</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</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/NCT03828864
org study id: X18-0425
nct id: NCT03828864
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to test the efficacy of the ActiPatch® device by means of a randomized double
      blind controlled trial in a convenience sample of chronic low back pain patients at RPAH pain
      clinic. Outcome measures are validated psychometric measures evaluating known determinants of
      pain related disability, functional capacity measures, and pain scores; and a bespoke
      questionnaire assessing fidelity with recommended usage, and willingness to reduce analgesic
      or other pain related medications with the future assistance of the ActiPatch®.
This study aims to test the efficacy of the ActiPatch® device by means of a randomised double
      blind controlled trial in a convenience sample of chronic low back pain patients at Royal
      Prince Alfred Hospital (RPAH) pain clinic. Outcome measures are validated psychometric
      measures evaluating known determinants of pain related disability, functional capacity
      measures, and pain scores; and a bespoke questionnaire assessing fidelity with recommended
      usage, and willingness to reduce analgesic or other pain related medications with the future
      assistance of the ActiPatch®.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Active medical device and and identical dummy device (placebo) that does not emit the pulsed shortwave signal.
measure: Brief Pain Inventory (BPI) Short Form
time frame: 30 days
description: The BPI-SF is a questionnaire - self-administered or by interview - that assesses both pain intensity and pain interference in common aspects of one's life. It has reliability & validity across cultural and language groups & is one of the standard measures used by the national Electronic Persistent Pain Outcomes Collaboration (ePPOC) that collates data from various Pain Management Centres to evaluate outcomes in pain clinics Australia wide.
Scoring
Question answers are complied into two categories:
Pain severity is 0 - 10, with 10 being worst pain possible
Pain inference score is 0 - 10, with 10 being worst possible pain inference
measure: Central Sensitisation Inventory - short form (CSI-9)
time frame: 30 days
description: Central Sensitisation (CS) is thought to be one underlying mechanism for the prevalence of chronic pain and the ActiPatch® device is believed to reduce central sensitization. Use of the CSI-9 will be used to assess the extent to which central sensitization is present in the study cohort and if use of the device produces a change in CS. This will then allow appraisal of the role of central sensitization in any outcomes achieved.
Scoring, scores are totaled from the assessment Five severity levels (subclinical = 0-29, mild = 30-39, moderate = 40-49, severe = 50-59, and severe = 60-100) central sensitization
measure: Pain Sleep Questionnaire (PSQ-3) Scoring 0-30 0 no sleep disturbance and 30 worst sleep disturbance
time frame: 30 days
description: The interaction between sleep disturbance and chronic pain is widely reported in the literature, and is thought to be a two way interaction. Use of the PSQ-3 will be used to assess the extent to which perceived sleep disturbance is present in the study cohort and if use of the ActiPatch® device is associated with a change in sleep quality. Addressing sleep quality may help to treat chronic pain including LBP and thereby have clinical treatment applications.
Scoring 0-30, 0 no sleep disturbance and 30 worst sleep disturbance Three visual analog scales of 0-10
arm group label: Active Pulsed Shortwave therapy
arm group type: Active Comparator
description: Application of the medical device emitting pulsed shortwave therapy. The medical device is used over the site of pain.
arm group label: Placebo Pulsed Shortwave therapy
arm group type: Placebo Comparator
description: Application of the medical device that does not emit pulsed shortwave therapy. The medical device is used over the site of pain.
intervention type: Device
intervention name: Pulsed Shortwave Therapy
description: Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
arm group label: Active Pulsed Shortwave therapy
other name: ActiPatch
intervention type: Device
intervention name: Placebo Pulsed Shortwave Therapy
description: Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
arm group label: Placebo Pulsed Shortwave therapy
other name: Placebo ActiPatch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Graeme Campbell
role: Principal Investigator
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
last name: Arun Aggarwal, Professor
role: Study Chair
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
last name: Graeme Campbell
phone: (02) 95159016
email: graeme.campbell1@health.nsw.gov.au
last name: Arun Aggarwal, Prof
phone: 02 9515 9870
email: arun.a@sydney.edu.au
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No