<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/NCT03005730</url>
  </required_header>
  <id_info>
    <org_study_id>PHOTOBIOMODULATION DTM EXT.</org_study_id>
    <nct_id>NCT03005730</nct_id>
  </id_info>
  <brief_title>Photobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint Dysfunction</brief_title>
  <official_title>Influence of Photobiomodulation In The Masseter and Temporal On Pain, Joint Mobility In Individuals With Temporomandibular Joint Dysfunction: Clinical Trial Randomised, Placebo-Controlled And Double-Blind</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: According to the International Association for the Study of Pain (IASP), the term&#xD;
      temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which&#xD;
      include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck&#xD;
      on one or both sides as well as joint sounds, limited mandibular movements or mandibular&#xD;
      deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and&#xD;
      light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain.&#xD;
      Thus, there is a need to investigate therapeutic resources that combine different wavelengths&#xD;
      as well as different light sources (LLLT and LED) in the same apparatus.&#xD;
&#xD;
      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,&#xD;
      activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint&#xD;
      mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine&#xD;
      the cumulative effect 24 and 48 hours after a six session.&#xD;
&#xD;
      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be&#xD;
      carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous&#xD;
      TMD. The participants will then be randomly allocated to two groups totaling 15 individuals&#xD;
      per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one&#xD;
      group will receive placebo therapy (0 Joules). The following assessment tools will be&#xD;
      administered on four separate occasions (baseline and immediately after, 24 h after and 48 h&#xD;
      after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,&#xD;
      meter for range of movement, and electromyographic EMG analysis on the masseter and anterior&#xD;
      temporal muscles.&#xD;
&#xD;
      Discussion: The study will support the practice of evidence-based to the use of phototherapy&#xD;
      in individuals with a myogenous TMD. Data will be published after the study is completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2016</start_date>
  <completion_date type="Actual">January 20, 2018</completion_date>
  <primary_completion_date type="Actual">May 10, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analog scale</measure>
    <time_frame>5 min</time_frame>
    <description>A Visual analog scale allows the quantification of pain intensity. This scale consists of a straight line measuring 10 cm in length, with &quot;absence of pain&quot; written at one end and &quot;worst pain ever felt&quot; written at the other end. The volunteer will be instructed to make a perpendicular line between the two extremes that represents the pain level he/she is feeling at the time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>10 min</time_frame>
    <description>We used a Starrett digital caliper ® to assess the breadth of mandibular movement (in mm), that is, the opening of the mouth was measured according to the RDC/TMD, and right and left lateral excursions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Temporomandibular Disorder</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Submitted to a session of phototherapy with 39,27 Joules per point in muscle masseter and temporal bilateral.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Submitted to a session of phototherapy placebo with 0,0 Joules per point in muscle masseter and temporal bilateral.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phototherapy</intervention_name>
    <description>The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phototherapy placebo</intervention_name>
    <description>The placebo portable. The aperture size of device is 4 cm2 .</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All volunteers will have a diagnosis of myogenous TMD based on the RDC/TMD with&#xD;
             moderate to severe pain in the masseter and temporal muscles rated by an expert&#xD;
             dentist. To standardize the sample, the body mass index of all participants must be&#xD;
             less than 25 kg/m2, as the amount of adipose tissue between the electrode and surface&#xD;
             of the muscle can affect that reading of the electromyographic (EMG) signal. All&#xD;
             volunteers must also have an initial pain score greater than 3 points on the VAS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria will be missing teeth, the use of dentures, systemic or&#xD;
             neuromuscular diseases, a history of trauma to the face or temporomandibular joint,&#xD;
             history of temporomandibular joint luxation, currently undergoing orthodontic&#xD;
             treatment, or currently undergoing medicinal treatment that can affect the&#xD;
             musculoskeletal system (analgesic, anti-inflammatory agent or muscle relaxant).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 25, 2018</last_update_submitted>
  <last_update_submitted_qc>January 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2018</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>Daniela Ap. Biasotto-Gonzalez</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </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>
    <mesh_term>Joint Diseases</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/NCT03005730
org study id: PHOTOBIOMODULATION DTM EXT.
nct id: NCT03005730
lead sponsor: 
has dmc: Yes
Background: According to the International Association for the Study of Pain (IASP), the term
      temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which
      include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck
      on one or both sides as well as joint sounds, limited mandibular movements or mandibular
      deviation and difficulties chewing. Phototherapy, such as low level laser therapy (LLLT) and
      light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain.
      Thus, there is a need to investigate therapeutic resources that combine different wavelengths
      as well as different light sources (LLLT and LED) in the same apparatus.

      Question: The aim of the proposed study is to evaluate the effects of phototherapy on pain,
      activity of the masticatory muscles (masseter and anterior temporal bilaterally) and joint
      mobility in individuals with temporomandibular disorder (TMD). A further aim is to determine
      the cumulative effect 24 and 48 hours after a six session.

      Methods/Design: A placebo-controlled, double-blind, randomized, clinical trial will be
      carried out involving 30 women between 18 and 40 years of age with a diagnosis of myogenous
      TMD. The participants will then be randomly allocated to two groups totaling 15 individuals
      per group. Group 1 submitted to a session of phototherapy with 39,27 Joules per point one
      group will receive placebo therapy (0 Joules). The following assessment tools will be
      administered on four separate occasions (baseline and immediately after, 24 h after and 48 h
      after phototherapy). Pain intensity will be assessed using the visual analog scale for pain,
      meter for range of movement, and electromyographic EMG analysis on the masseter and anterior
      temporal muscles.

      Discussion: The study will support the practice of evidence-based to the use of phototherapy
      in individuals with a myogenous TMD. Data will be published after the study is completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual analog scale
time frame: 5 min
description: A Visual analog scale allows the quantification of pain intensity. This scale consists of a straight line measuring 10 cm in length, with "absence of pain" written at one end and "worst pain ever felt" written at the other end. The volunteer will be instructed to make a perpendicular line between the two extremes that represents the pain level he/she is feeling at the time
measure: Range of motion
time frame: 10 min
description: We used a Starrett digital caliper ® to assess the breadth of mandibular movement (in mm), that is, the opening of the mouth was measured according to the RDC/TMD, and right and left lateral excursions.
arm group label: Group 1
arm group type: Experimental
description: Submitted to a session of phototherapy with 39,27 Joules per point in muscle masseter and temporal bilateral.
arm group label: Group 2
arm group type: Placebo Comparator
description: Submitted to a session of phototherapy placebo with 0,0 Joules per point in muscle masseter and temporal bilateral.
intervention type: Other
intervention name: phototherapy
description: The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.
arm group label: Group 1
intervention type: Other
intervention name: phototherapy placebo
description: The placebo portable. The aperture size of device is 4 cm2 .
arm group label: Group 2
criteria: 
gender: Female
minimum age: 1 Year
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Daniela Ap. Biasotto-Gonzalez
investigator title: Doctor
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
mesh term: Joint Diseases