<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/NCT04415281</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000766</org_study_id>
    <nct_id>NCT04415281</nct_id>
  </id_info>
  <brief_title>Photobiomodulation for the Management of Temporomandibular Disorder Pain</brief_title>
  <acronym>PBM</acronym>
  <official_title>Photobiomodulation for the Management of Temporomandibular Disorder Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
      Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but&#xD;
      there is no indication for TMD. Our goal in this study is to conduct a clinical trial of&#xD;
      multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in&#xD;
      inflammation contribute to PBM's analgesic effects. This study will be a double-blind,&#xD;
      sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 28, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Level Change with PBM treatment using a Numerical Rating Scale 0=no pain and 100=the most intense pain imaginable</measure>
    <time_frame>Through study completion; an average of 10 weeks</time_frame>
    <description>Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain &amp; Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Pain Related to TMD</condition>
  <arm_group>
    <arm_group_label>Active PBM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham PBM</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>THOR® laser system</intervention_name>
    <description>We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.</description>
    <arm_group_label>Active PBM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham THOR® laser system</intervention_name>
    <description>sham THOR® laser system</description>
    <arm_group_label>Sham PBM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provides a signed and dated informed consent form&#xD;
&#xD;
          -  Is at least 18 years of age (male or female and any race or ethnicity)&#xD;
&#xD;
          -  Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)&#xD;
&#xD;
          -  Has experienced facial pain for at least 3 months&#xD;
&#xD;
          -  At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating&#xD;
             over the past week of ≥ 30 on a numerical rating scale (0-100)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Starting a new daily prescription medication for the management of pain within 30 days&#xD;
             prior to treatment session;&#xD;
&#xD;
          -  Use of any injection therapy (e.g., tender or trigger point injections, steroid&#xD;
             injections) for the management of pain within 2 weeks prior to the CATI;&#xD;
&#xD;
          -  Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial&#xD;
             trauma or orofacial surgery within 6 weeks prior to CATI;&#xD;
&#xD;
          -  Active orthodontic treatment;&#xD;
&#xD;
          -  Psychiatric hospitalization within one year prior to screening.&#xD;
&#xD;
          -  Has known hypersensitivity to laser therapy.&#xD;
&#xD;
          -  Currently being treated with chemotherapy or radiation therapy&#xD;
&#xD;
          -  Has been treated with another investigational drug or treatment within 30 days prior&#xD;
             to the Screening and Baseline Visit&#xD;
&#xD;
          -  Is pregnant or nursing&#xD;
&#xD;
          -  Anything that, in the opinion of the investigator, would place the participant at&#xD;
             increased risk or preclude the participant's full compliance with or completion of the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margarete Ribeiro-Dasilva, DDS, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</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>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 3, 2023</submitted>
    <returned>August 21, 2023</returned>
    <submitted>September 8, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04415281
org study id: IRB202000766
nct id: NCT04415281
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but
      there is no indication for TMD. Our goal in this study is to conduct a clinical trial of
      multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in
      inflammation contribute to PBM's analgesic effects. This study will be a double-blind,
      sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain Level Change with PBM treatment using a Numerical Rating Scale 0=no pain and 100=the most intense pain imaginable
time frame: Through study completion; an average of 10 weeks
description: Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain & Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.
arm group label: Active PBM
arm group type: Experimental
description: PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.
arm group label: Sham PBM
arm group type: Sham Comparator
description: When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.
intervention type: Device
intervention name: THOR® laser system
description: We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.
arm group label: Active PBM
intervention type: Device
intervention name: sham THOR® laser system
description: sham THOR® laser system
arm group label: Sham PBM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Margarete Ribeiro-Dasilva, DDS, MS, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: No
submitted: August 3, 2023
returned: August 21, 2023
submitted: September 8, 2023