<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/NCT04468516</url>
  </required_header>
  <id_info>
    <org_study_id>10010563</org_study_id>
    <nct_id>NCT04468516</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation</brief_title>
  <official_title>Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wilfrid Laurier University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KKT International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wilfrid Laurier University</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic back and neck pain is the most common chronic condition worldwide. Unfortunately, the&#xD;
      current available treatment options are limited and largely unsuccessful, which is considered&#xD;
      as one of the primary drivers for the high cost of back pain management. Systematic reviews&#xD;
      show that the results of common treatments including pain medications, surgery, exercise and&#xD;
      psychological therapies for back pain demonstrate inconsistent results and moderate&#xD;
      improvement. Therefore, non-invasive adjunct therapies can be a useful addition to&#xD;
      traditional back pain management.&#xD;
&#xD;
      Focused vibroacoustic treatment for back and neck pain is a non-invasive procedure that&#xD;
      applies low frequency sound waves to the spine (50Hz-110Hz), and has shown consistent and&#xD;
      positive results in early clinical and animal studies. The goal of this project is to test&#xD;
      vibroacoustic sound waves delivered to the spine in a double blind randomized controlled&#xD;
      trial to demonstrate the efficacy of focused vibroacoustics in treating chronic back pain.&#xD;
&#xD;
      Participants with back pain will be recruited and divided into a treatment and placebo group&#xD;
      and will undergo treatment at a clinic over a one month period. Outcome measures will be&#xD;
      collected before and after the intervention period. Placebo participants will be offered the&#xD;
      full treatment without charge after the experiment is over.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2022</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>
    <intervention_model_description>Parallel double blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>There are two groups (treatment and placebo). Participants will not know which group they are in until the end. Masking will be maintained by the following plan:&#xD;
Researcher assigning participants to treatment and control groups: Dr. Abdullah Mosabbir.&#xD;
Researcher(s)/clinician(s) performing pre-treatment/post-treatment assessments: Dr. Aslam Khan, or a Clinician hired by KKT who is NOT doing #3.&#xD;
Researcher(s)/clinician(s) performing treatments or sham procedure: Dr. Peter Dyback, or a Clinician hired by KKT who is NOT doing #2.&#xD;
Researcher who will assemble these data, code it, and do the data analysis: Dr. Abdullah Mosabbir.&#xD;
Researchers who will supervise the design and ethical conduct of the study as well as data analysis: Dr. Heidi Ahonen and Dr. Quincy Almeida.&#xD;
Researchers whose role is conceptual: Dr.Karim Bayanzay, Dr. Lidan You, and Dr. Lee Bartel.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of Visual Analog Scale for Pain</measure>
    <time_frame>1 month</time_frame>
    <description>A scale which measures the intensity of pain. Scored from 0 to 100. 0 means no pain, 100 means maximum pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of Roland Morris Disability Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Measures back pain disability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline of EuroQol (EQ5D-5L) Questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Quality of Life Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Neck Pain Disability Index</measure>
    <time_frame>1 month</time_frame>
    <description>Measures neck pain disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Dosage</measure>
    <time_frame>1 month</time_frame>
    <description>The assessor will ask what medications the participant is taking. They will record the drug and dosage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Shoulder and Pelvis tilt</measure>
    <time_frame>1 month</time_frame>
    <description>Measured via calipers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Leg length</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cervical range of motion</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Palpatory tenderness of the spine</measure>
    <time_frame>1 month</time_frame>
    <description>The assessor will count and record the number of tender regions along the spine.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is applied to the C1 of the spine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention is applied in reduced intensity to the trapezius muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist period</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will have a 1 month waitlist period where no intervention takes place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KKT</intervention_name>
    <description>Vibroacoustic sound waves applied focally.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham KKT</intervention_name>
    <description>sham KKT</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of chronic low back pain with a disease duration of more than 3&#xD;
             months (further diagnostic results were not required)&#xD;
&#xD;
          -  Aged 18-75.&#xD;
&#xD;
          -  Scored at least 4/10 in pain scale (VAS or Numerical)&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute back pain (&lt; 4 weeks)&#xD;
&#xD;
          -  History of spinal or vertebral surgery&#xD;
&#xD;
          -  History of any vertebral or spinal infection&#xD;
&#xD;
          -  History of significant trauma related to the spine&#xD;
&#xD;
          -  History of IV drug use&#xD;
&#xD;
          -  History of malignancy&#xD;
&#xD;
          -  Congenital deformation of the spine (except mild scoliosis or kyphosis)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous KKT Treatment&#xD;
&#xD;
          -  Undergoing concurrent treatment Unable to complete all 12 treatment sessions due to&#xD;
             travel, distance or transportation issues, etc.&#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>Abdullah A Mosabbir, PhD</last_name>
    <phone>6477875430</phone>
    <email>Abdullah.Mosabbir@kktspinetreatment.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heidi J Ahonen, PhD</last_name>
    <phone>519.884.0710</phone>
    <phone_ext>x2431</phone_ext>
    <email>hahonen@wlu.ca</email>
  </overall_contact_backup>
  <reference>
    <citation>Desmoulin GT, Yasin NI, Chen DW. Spinal mechanisms of pain control. Clin J Pain. 2007 Sep;23(7):576-85. doi: 10.1097/AJP.0b013e3180e00eb8.</citation>
    <PMID>17710007</PMID>
  </reference>
  <reference>
    <citation>Desmoulin GT, Hewitt CR, Hunter CJ. Disc strain and resulting positive mRNA expression from application of a noninvasive treatment. Spine (Phila Pa 1976). 2011 Jun 15;36(14):E921-8. doi: 10.1097/BRS.0b013e3181fd78b3.</citation>
    <PMID>21289569</PMID>
  </reference>
  <reference>
    <citation>Desmoulin GT, Reno CR, Hunter CJ. Free axial vibrations at 0 to 200 Hz positively affect extracellular matrix messenger ribonucleic acid expression in bovine nucleus pulposi. Spine (Phila Pa 1976). 2010 Jul 1;35(15):1437-44. doi: 10.1097/BRS.0b013e3181c2a8ec.</citation>
    <PMID>20386503</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wilfrid Laurier University</investigator_affiliation>
    <investigator_full_name>Abdullah Mosabbir</investigator_full_name>
    <investigator_title>Principal Site 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/NCT04468516
org study id: 10010563
nct id: NCT04468516
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Chronic back and neck pain is the most common chronic condition worldwide. Unfortunately, the
      current available treatment options are limited and largely unsuccessful, which is considered
      as one of the primary drivers for the high cost of back pain management. Systematic reviews
      show that the results of common treatments including pain medications, surgery, exercise and
      psychological therapies for back pain demonstrate inconsistent results and moderate
      improvement. Therefore, non-invasive adjunct therapies can be a useful addition to
      traditional back pain management.

      Focused vibroacoustic treatment for back and neck pain is a non-invasive procedure that
      applies low frequency sound waves to the spine (50Hz-110Hz), and has shown consistent and
      positive results in early clinical and animal studies. The goal of this project is to test
      vibroacoustic sound waves delivered to the spine in a double blind randomized controlled
      trial to demonstrate the efficacy of focused vibroacoustics in treating chronic back pain.

      Participants with back pain will be recruited and divided into a treatment and placebo group
      and will undergo treatment at a clinic over a one month period. Outcome measures will be
      collected before and after the intervention period. Placebo participants will be offered the
      full treatment without charge after the experiment is over.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel double blind randomized controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: There are two groups (treatment and placebo). Participants will not know which group they are in until the end. Masking will be maintained by the following plan:
Researcher assigning participants to treatment and control groups: Dr. Abdullah Mosabbir.
Researcher(s)/clinician(s) performing pre-treatment/post-treatment assessments: Dr. Aslam Khan, or a Clinician hired by KKT who is NOT doing #3.
Researcher(s)/clinician(s) performing treatments or sham procedure: Dr. Peter Dyback, or a Clinician hired by KKT who is NOT doing #2.
Researcher who will assemble these data, code it, and do the data analysis: Dr. Abdullah Mosabbir.
Researchers who will supervise the design and ethical conduct of the study as well as data analysis: Dr. Heidi Ahonen and Dr. Quincy Almeida.
Researchers whose role is conceptual: Dr.Karim Bayanzay, Dr. Lidan You, and Dr. Lee Bartel.
measure: Change from baseline of Visual Analog Scale for Pain
time frame: 1 month
description: A scale which measures the intensity of pain. Scored from 0 to 100. 0 means no pain, 100 means maximum pain.
measure: Change from baseline of Roland Morris Disability Questionnaire
time frame: 1 month
description: Measures back pain disability.
measure: Change in baseline of EuroQol (EQ5D-5L) Questionnaire
time frame: 1 month
description: Quality of Life Questionnaire
measure: Change in Neck Pain Disability Index
time frame: 1 month
description: Measures neck pain disability
measure: Change in Medication Dosage
time frame: 1 month
description: The assessor will ask what medications the participant is taking. They will record the drug and dosage.
measure: Change in Shoulder and Pelvis tilt
time frame: 1 month
description: Measured via calipers
measure: Change in Leg length
time frame: 1 month
measure: Change in Cervical range of motion
time frame: 1 month
measure: Change in Palpatory tenderness of the spine
time frame: 1 month
description: The assessor will count and record the number of tender regions along the spine.
arm group label: Treatment
arm group type: Experimental
description: Intervention is applied to the C1 of the spine.
arm group label: Placebo
arm group type: Placebo Comparator
description: Intervention is applied in reduced intensity to the trapezius muscle.
arm group label: Waitlist period
arm group type: No Intervention
description: Participants will have a 1 month waitlist period where no intervention takes place.
intervention type: Device
intervention name: KKT
description: Vibroacoustic sound waves applied focally.
arm group label: Treatment
intervention type: Device
intervention name: sham KKT
description: sham KKT
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Abdullah A Mosabbir, PhD
phone: 6477875430
email: Abdullah.Mosabbir@kktspinetreatment.com
last name: Heidi J Ahonen, PhD
phone: 519.884.0710
phone ext: x2431
email: hahonen@wlu.ca
citation: Desmoulin GT, Yasin NI, Chen DW. Spinal mechanisms of pain control. Clin J Pain. 2007 Sep;23(7):576-85. doi: 10.1097/AJP.0b013e3180e00eb8.
PMID: 17710007
citation: Desmoulin GT, Hewitt CR, Hunter CJ. Disc strain and resulting positive mRNA expression from application of a noninvasive treatment. Spine (Phila Pa 1976). 2011 Jun 15;36(14):E921-8. doi: 10.1097/BRS.0b013e3181fd78b3.
PMID: 21289569
citation: Desmoulin GT, Reno CR, Hunter CJ. Free axial vibrations at 0 to 200 Hz positively affect extracellular matrix messenger ribonucleic acid expression in bovine nucleus pulposi. Spine (Phila Pa 1976). 2010 Jul 1;35(15):1437-44. doi: 10.1097/BRS.0b013e3181c2a8ec.
PMID: 20386503
responsible party type: Principal Investigator
investigator affiliation: Wilfrid Laurier University
investigator full name: Abdullah Mosabbir
investigator title: Principal Site Investigator
mesh term: Back Pain
sharing ipd: No