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Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction

Primary Purpose

Low Level Laser Therapy, Temporomandibular Joint Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conventional therapy
low level laser therapy
Sponsored by
Emad Eldin Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Level Laser Therapy focused on measuring conventional therapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients are diagnosed as myofascial pain syndrome of TMJ.

Exclusion Criteria:

  • Presence of systematic musculo-articular pathologies.
  • Pregnant women.
  • History of facial trauma.
  • Facial palsy.
  • Fractures of the facial bones.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    conventional therapy (group I)

    low level laser therapy (groupII)

    Arm 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

    LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.

    Outcomes

    Primary Outcome Measures

    Pain algometry

    Secondary Outcome Measures

    Jaw Functional questionnaire

    Full Information

    First Posted
    September 16, 2017
    Last Updated
    September 18, 2017
    Sponsor
    Emad Eldin Mohamed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03287531
    Brief Title
    Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction
    Official Title
    Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 10, 2016 (Actual)
    Primary Completion Date
    August 12, 2017 (Actual)
    Study Completion Date
    August 23, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Emad Eldin Mohamed

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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:

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Level Laser Therapy, Temporomandibular Joint Dysfunction
    Keywords
    conventional therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional therapy (group I)
    Arm Type
    Experimental
    Arm 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 Title
    low level laser therapy (groupII)
    Arm Type
    Experimental
    Arm 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(s)
    conventional therapy
    Other Intervention Name(s)
    I
    Intervention Description
    Exercise therapeutic Ultrasound
    Intervention Type
    Other
    Intervention Name(s)
    low level laser therapy
    Other Intervention Name(s)
    II
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Pain algometry
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Jaw Functional questionnaire
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients are diagnosed as myofascial pain syndrome of TMJ. Exclusion Criteria: Presence of systematic musculo-articular pathologies. Pregnant women. History of facial trauma. Facial palsy. Fractures of the facial bones.

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction

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