xml: <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/NCT06007976</url>
    </required_header>
    <id_info>
      <org_study_id>23-004998</org_study_id>
      <nct_id>NCT06007976</nct_id>
    </id_info>
    <brief_title>LLLT to Reduce Low Back Pain</brief_title>
    <official_title>Impact of Variable Treatment Frequencies of Low-Level Laser in Reduce Low-Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Erchonia Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Mayo Clinic</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>
        The purpose of this research study is to gather information on the effectiveness of the&#xD;
        Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals&#xD;
        to reduce lower back pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be administered one of 4 treatment options using the Trident LLLT. The&#xD;
        treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All&#xD;
        patients will receive two self-help patient education manuals. Low Back Pain will be compared&#xD;
        among all 4 options at the end of week 6.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Brief Pain Inventory score</measure>
      <time_frame>Baseline, Week 6</time_frame>
      <description>The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Brief Pain Inventory score</measure>
      <time_frame>Baseline, Week 24</time_frame>
      <description>The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>2 treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4 treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>6 treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>8 treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Erchonia® Trident</intervention_name>
      <description>Low-level laser therapy</description>
      <arm_group_label>2 treatment</arm_group_label>
      <arm_group_label>4 treatment</arm_group_label>
      <arm_group_label>6 treatment</arm_group_label>
      <arm_group_label>8 treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Reporting a primary pain point in lower back.&#xD;
  &#xD;
            -  Pain intensity reported at baseline must be 4 and above on the Visual Analogue scale&#xD;
               (PROMIS Numeric Rating Scale).&#xD;
  &#xD;
            -  Individual able to participate fully in all aspects of the study and have understood&#xD;
               and signed study informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have used pain medications or participated in a pain treatment within three days of&#xD;
               study enrollment.&#xD;
  &#xD;
            -  Have an implanted device (including lap band) in the targeted area of Low Level Laser&#xD;
               Treatment.&#xD;
  &#xD;
            -  Have used an investigational drug within 30 days of study enrollment.&#xD;
  &#xD;
            -  Reports being currently pregnant, lactating, or are of child-bearing potential or are&#xD;
               likely to become pregnant during the low level laser treatment phase and are unwilling&#xD;
               to use a reliable form of contraception. Acceptable forms of contraception include:&#xD;
               Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or&#xD;
               implants; Barrier methods (such as a condom or diaphragm) used with a spermicide (a&#xD;
               foam, cream, or gel that kills sperm); Intrauterine device (IUD); Total hysterectomy&#xD;
               or tubal ligation; Abstinence (no sex).&#xD;
  &#xD;
            -  Have a history of any major cardiovascular events including heart valve disease,&#xD;
               ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary&#xD;
               syndrome, stroke, transient ischemic attack, or peripheral vascular disease.&#xD;
  &#xD;
            -  Have clinically significant acute or chronic progressive or unstable neurologic,&#xD;
               hepatic, renal, cardiovascular, lymphatic, respiratory, metabolic disease (such as&#xD;
               uncontrolled diabetes type 2), active cancer, actively receiving l treatment for&#xD;
               cancer or within 1 year of cancer remission.&#xD;
  &#xD;
            -  Surgical intervention for pain within 1 month prior to enrollment.&#xD;
  &#xD;
            -  Active infection, wound or other external trauma to the areas to be treated with the&#xD;
               laser&#xD;
  &#xD;
            -  Known photosensitivity disorder.&#xD;
  &#xD;
            -  Have a known history of any condition or factor judged by the investigator to preclude&#xD;
               participation in the study or which might hinder adherence.&#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>Ivana T Croghan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ryan T Hurt, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shawn Fokken</last_name>
      <phone>507-293-2740</phone>
      <email>Fokken.Shawn@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Ivana T Croghan, PhD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>laser</keyword>
    <keyword>LLLT</keyword>
    <keyword>back pain</keyword>
    <keyword>pain</keyword>
    <keyword>low back pain</keyword>
    <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>
  
  
text: 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/NCT06007976
  org study id: 23-004998
  nct id: NCT06007976
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this research study is to gather information on the effectiveness of the
        Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals
        to reduce lower back pain.
  Patients will be administered one of 4 treatment options using the Trident LLLT. The
        treatment options include 2 treatments, 4 treatments, 6 treatments or 8 treatments. All
        patients will receive two self-help patient education manuals. Low Back Pain will be compared
        among all 4 options at the end of week 6.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: All patients will self-select one of four treatment options: 1 week (2 treatment), 2 weeks (4 treatments), 3 weeks (6 treatments) and 4 weeks (8 treatments).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Brief Pain Inventory score
  time frame: Baseline, Week 6
  description: The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
  measure: Change in Brief Pain Inventory score
  time frame: Baseline, Week 24
  description: The PROMIS Numeric Rating Scale v1.0 - Pain Intensity 1a will be used to measure pain intensity on a VAS scale where '0' is no pain and '10' being the worst imaginable pain.
  arm group label: 2 treatment
  arm group type: Experimental
  description: Subjects will receive 2 low-level laser therapy treatments of 20 minutes for low back pain.
  arm group label: 4 treatment
  arm group type: Experimental
  description: Subjects will receive 4 low-level laser therapy treatments of 20 minutes over 2 weeks for low back pain.
  arm group label: 6 treatment
  arm group type: Experimental
  description: Subjects will receive 6 low-level laser therapy treatments of 20 minutes over 3 weeks for low back pain.
  arm group label: 8 treatment
  arm group type: Experimental
  description: Subjects will receive 8 low-level laser therapy treatments of 20 minutes over 4 weeks for low back pain.
  intervention type: Device
  intervention name: Erchonia® Trident
  description: Low-level laser therapy
  arm group label: 2 treatment
  arm group label: 4 treatment
  arm group label: 6 treatment
  arm group label: 8 treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ivana T Croghan, PhD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Ryan T Hurt, MD, PhD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Shawn Fokken
  phone: 507-293-2740
  email: Fokken.Shawn@mayo.edu
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Ivana T Croghan, PhD
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No