<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/NCT03287531</url>
  </required_header>
  <id_info>
    <org_study_id>00500</org_study_id>
    <nct_id>NCT03287531</nct_id>
  </id_info>
  <brief_title>Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction</brief_title>
  <official_title>Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emad Eldin Mohamed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>October 6 University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was to determine the effect of conventional therapy and low level laser therapy on&#xD;
      pain and function in patients with temporomandibular joint dysfunction. sixty patients with&#xD;
      myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients&#xD;
      in each group; Group I received traditional exercise. Group II received low level laser&#xD;
      therapy in addition to traditional exercise. All outcome measures including Pain and&#xD;
      function, were evaluated before and after the treatment program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODOLOGY&#xD;
&#xD;
      Subjects: This prospective study was conducted on thirty patients of both genders with&#xD;
      myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university&#xD;
      Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into&#xD;
      this study according to the following criteria:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2016</start_date>
  <completion_date type="Actual">August 23, 2017</completion_date>
  <primary_completion_date type="Actual">August 12, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain algometry</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jaw Functional questionnaire</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Low Level Laser Therapy</condition>
  <condition>Temporomandibular Joint Dysfunction</condition>
  <arm_group>
    <arm_group_label>conventional therapy (group I)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise therapy.&#xD;
For muscles around TMJ :&#xD;
Masetter Lateral Pterygoid Medial Pterygoid Temporalis Digastric&#xD;
Pulsed ultrasound at 0.3 to 0.6 watts per sq cm over the lateral poles of the temporomandibular joint condyles with a small sound head for 2 to 3 minutes per side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low level laser therapy (groupII)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional therapy</intervention_name>
    <description>Exercise therapeutic Ultrasound</description>
    <arm_group_label>conventional therapy (group I)</arm_group_label>
    <other_name>I</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low level laser therapy</intervention_name>
    <description>LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.</description>
    <arm_group_label>conventional therapy (group I)</arm_group_label>
    <arm_group_label>low level laser therapy (groupII)</arm_group_label>
    <other_name>II</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients are diagnosed as myofascial pain syndrome of TMJ.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of systematic musculo-articular pathologies.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  History of facial trauma.&#xD;
&#xD;
          -  Facial palsy.&#xD;
&#xD;
          -  Fractures of the facial bones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>October 6 University</investigator_affiliation>
    <investigator_full_name>Emad Eldin Mohamed</investigator_full_name>
    <investigator_title>Effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction</investigator_title>
  </responsible_party>
  <keyword>conventional therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</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/NCT03287531
org study id: 00500
nct id: NCT03287531
lead sponsor: 
has dmc: Yes
This study was to determine the effect of conventional therapy and low level laser therapy on
      pain and function in patients with temporomandibular joint dysfunction. sixty patients with
      myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients
      in each group; Group I received traditional exercise. Group II received low level laser
      therapy in addition to traditional exercise. All outcome measures including Pain and
      function, were evaluated before and after the treatment program.
METHODOLOGY

      Subjects: This prospective study was conducted on thirty patients of both genders with
      myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university
      Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into
      this study according to the following criteria:
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain algometry
time frame: 4 weeks
measure: Jaw Functional questionnaire
time frame: 4 weeks
arm group label: conventional therapy (group I)
arm group type: Experimental
description: Exercise therapy.
For muscles around TMJ :
Masetter Lateral Pterygoid Medial Pterygoid Temporalis Digastric
Pulsed ultrasound at 0.3 to 0.6 watts per sq cm over the lateral poles of the temporomandibular joint condyles with a small sound head for 2 to 3 minutes per side
arm group label: low level laser therapy (groupII)
arm group type: Experimental
description: LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.
intervention type: Other
intervention name: conventional therapy
description: Exercise therapeutic Ultrasound
arm group label: conventional therapy (group I)
other name: I
intervention type: Other
intervention name: low level laser therapy
description: LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.
arm group label: conventional therapy (group I)
arm group label: low level laser therapy (groupII)
other name: II
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: October 6 University
investigator full name: Emad Eldin Mohamed
investigator title: Effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome