<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/NCT04476095</url>
  </required_header>
  <id_info>
    <org_study_id>2.732.044</org_study_id>
    <nct_id>NCT04476095</nct_id>
  </id_info>
  <brief_title>Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)</brief_title>
  <official_title>Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Multi Radiance Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nove de Julho</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>
      Low back pain (LBP) is a highly prevalent condition worldwide and the leading cause of years&#xD;
      lived with disability. In most cases, the specific pathological cause remains unidentified;&#xD;
      therefore, the term non-specific low back pain is commonly used for such cases. Many&#xD;
      non-pharmacological therapies are available for the treatment of low back pain aiming to&#xD;
      reduce pain and disability. Among these options, photobiomodulation therapy (PBMT) it seems&#xD;
      to be an interesting alternative. PBMT is a non-thermal and non-invasive clinical treatment,&#xD;
      which has shown effects in decreased pain, modulation of inflammatory process, and tissue&#xD;
      repair in musculoskeletal disorders. Therefore, the aim of this project is to evaluate the&#xD;
      effects of the PBMT against placebo on pain intensity in patients with chronic non-specific&#xD;
      low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve the proposed objective, it will be performed a randomized, triple-blind (patients,&#xD;
      therapists, and outcome assessors), placebo-controlled trial.&#xD;
&#xD;
      Seventy-two patients with chronic non-specific low back pain will be randomly allocated to&#xD;
      two treatment groups: 1. Active PBMT or Placebo PBMT.&#xD;
&#xD;
      In both groups, six treatment sessions will be performed twice a week (at the same time of&#xD;
      the day), with intervals of three or four days between sessions, during three-week period.&#xD;
      The patients will be treated by a blinded therapist.&#xD;
&#xD;
      The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of&#xD;
      treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion&#xD;
      of treatment. The data will be collected by a blinded assessor.&#xD;
&#xD;
      Statistical analyzis:&#xD;
&#xD;
        -  The Fischer's Exact Test will be conducted to compare the proportion of successes&#xD;
           between groups.&#xD;
&#xD;
        -  The Unpaired t-test will be used for demographic data.&#xD;
&#xD;
        -  Repeated measures ANOVA will be performed to analyze pain intensity. The level of&#xD;
           statistical significance will be set at p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2, 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>A researcher will program the device (placebo PBMT or active PMBT) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or PBMT).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>3 weeks (end of treatment)</time_frame>
    <description>Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction</measure>
    <time_frame>3 weeks (end of treatment).</time_frame>
    <description>Subject satisfaction will be measured by scale uses the following responses: &quot;very satisfied&quot;, &quot;somewhat satisfied&quot;, &quot;neither satisfied nor dissatisfied&quot;, &quot;not very satisfied&quot; or &quot;not at all satisfied&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control of concomitant medication intake</measure>
    <time_frame>3 weeks (end of treatment).</time_frame>
    <description>The control of concomitant medication intake will be measured by a individualized pain management diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.</time_frame>
    <description>Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Active PBMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo PBMT</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active PBMT</intervention_name>
    <description>Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.</description>
    <arm_group_label>Active PBMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo PBMT</intervention_name>
    <description>The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).</description>
    <arm_group_label>Placebo PBMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic non-specific low back pain, with symptoms present for at least&#xD;
             three months;&#xD;
&#xD;
          -  Patients with a pain intensity of at least 50mm (measured by a 0-100 mm Visual Analog&#xD;
             Scale);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious spinal pathologies (such as fractures, tumors, inflammatory, and infectious&#xD;
             diseases);&#xD;
&#xD;
          -  Patients who used local corticosteroids and/or botulin toxin injection for pain relief&#xD;
             within the prior 30 days of the beginning of the study;&#xD;
&#xD;
          -  Chronic pain diseases as fibromyalgia and diabetic type 1;&#xD;
&#xD;
          -  Neuropathic pain;&#xD;
&#xD;
          -  Previous spinal surgery in the past 12 months;&#xD;
&#xD;
          -  Cancer patients;&#xD;
&#xD;
          -  Pregnancy or breast feeding.&#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_contact>
    <last_name>Ernesto Cesar Pinto Leal Junior, PhD</last_name>
    <phone>+55 11 33859134</phone>
    <email>ernesto.leal.junior@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Laboratory of Phototherapy and Innovative Technologies in Health</name>
      <address>
        <city>São Paulo</city>
        <zip>01504-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Ernesto Cesar Pinto Leal Junior</investigator_full_name>
    <investigator_title>Full professor</investigator_title>
  </responsible_party>
  <keyword>Photobiomodulation Therapy</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>
  <!-- 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/NCT04476095
org study id: 2.732.044
nct id: NCT04476095
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Low back pain (LBP) is a highly prevalent condition worldwide and the leading cause of years
      lived with disability. In most cases, the specific pathological cause remains unidentified;
      therefore, the term non-specific low back pain is commonly used for such cases. Many
      non-pharmacological therapies are available for the treatment of low back pain aiming to
      reduce pain and disability. Among these options, photobiomodulation therapy (PBMT) it seems
      to be an interesting alternative. PBMT is a non-thermal and non-invasive clinical treatment,
      which has shown effects in decreased pain, modulation of inflammatory process, and tissue
      repair in musculoskeletal disorders. Therefore, the aim of this project is to evaluate the
      effects of the PBMT against placebo on pain intensity in patients with chronic non-specific
      low back pain.
To achieve the proposed objective, it will be performed a randomized, triple-blind (patients,
      therapists, and outcome assessors), placebo-controlled trial.

      Seventy-two patients with chronic non-specific low back pain will be randomly allocated to
      two treatment groups: 1. Active PBMT or Placebo PBMT.

      In both groups, six treatment sessions will be performed twice a week (at the same time of
      the day), with intervals of three or four days between sessions, during three-week period.
      The patients will be treated by a blinded therapist.

      The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of
      treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion
      of treatment. The data will be collected by a blinded assessor.

      Statistical analyzis:

        -  The Fischer's Exact Test will be conducted to compare the proportion of successes
           between groups.

        -  The Unpaired t-test will be used for demographic data.

        -  Repeated measures ANOVA will be performed to analyze pain intensity. The level of
           statistical significance will be set at p<0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: A researcher will program the device (placebo PBMT or active PMBT) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT or placebo). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or PBMT).
measure: Pain intensity
time frame: 3 weeks (end of treatment)
description: Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).
measure: Subject satisfaction
time frame: 3 weeks (end of treatment).
description: Subject satisfaction will be measured by scale uses the following responses: "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "not very satisfied" or "not at all satisfied".
measure: Control of concomitant medication intake
time frame: 3 weeks (end of treatment).
description: The control of concomitant medication intake will be measured by a individualized pain management diary.
measure: Pain intensity
time frame: 24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment.
description: Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS).
arm group label: Active PBMT
arm group type: Experimental
description: Active PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).
arm group label: Placebo PBMT
arm group type: Placebo Comparator
description: Placebo PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions).
intervention type: Device
intervention name: Active PBMT
description: Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.
arm group label: Active PBMT
intervention type: Device
intervention name: Placebo PBMT
description: The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
arm group label: Placebo PBMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ernesto Cesar Pinto Leal Junior, PhD
phone: +55 11 33859134
email: ernesto.leal.junior@gmail.com
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Ernesto Cesar Pinto Leal Junior
investigator title: Full professor
mesh term: Back Pain
mesh term: Low Back Pain