Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction
Effect of High-intensity Laser Therapy on Temporalis and Masseter Muscles Activity in Patients With Myogenic Temporomandibular Joint Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Temporomandibular joint dysfunction (TMD) is one of the problems that affect the quality of lifestyle through the presence of pain around the joint radiated in the face, neck, or shoulders muscles and a decrease in function of the temporomandibular joint that leads to difficulty in mastication, swallowing, earaches, dizziness, and hearing problems may sometimes be associated with TMD.
High-intensity laser therapy (HILT) is a laser with a wavelength of 1064 nm and has recently been used in the treatment of musculoskeletal diseases. Its primary effect is the analgesic effect and reactive vasodilation by affecting the cutaneous nerve endings. Another mechanism of action is based on tissue stimulation. This stimulation occurs at the level of cells, vascular tissue, interstitial tissue, and the immune system. It increases regeneration and beta-endorphin release by inducing protein synthesis in synovial fluid, thus exerting analgesic and anti-inflammatory effects.
Since there is a lack of literature studying the effect of HILT on masseter and temporalis muscles activity in patients with myogenic TMD so, this study may provide a baseline for a new technique in rehabilitation intervention in patients with myogenic TMD.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohaya Mohamed, PHD
- Phone Number: +201065150305
- Email: Mohayaahmed88@yahoo.com
Study Contact Backup
- Name: Yasser Lasheen, PHD
- Phone Number: 01005251562
- Email: dr_yasser_1977@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients from both gender with unilateral myogenic temporomandibular dysfunction (TMD) with trismus diagnosed and referred from maxillofacial specialist.
- Aged between 20 to 45 years old .
- Visual analogue scale (VAS) score >3 for unilateral myogenic pain of the temporomandibular joint (TMJ).
- Pain lasting at least 3 months.
- Patients were diagnosed as unilateral myogenic pain.
Exclusion Criteria:
- Previous TMJ surgery.
- History of jaw dislocation.
- History of jaw fracture.
- Previous therapy with occlusal splint.
- Concomitant therapy of bruxism.
- Presence of removable oral prosthesis.
- Metal implants in the skull.
- Presence of hearing aids.
- Malignancy.
- Pregnancy.
- Diabetic patients.
- Hypertensive patients.
- Systemic rheumatologic disease
- Systemic infection.
- Inserted cardiac pacemaker.
- Presence of coagulation disorders.
- Trigeminal neuritis.
- Cognitive dysfunction.
- Bilateral TMD.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-intensity laser therapy group
Patients will receive pulsed high-intensity laser therapy in addition to conventional treatment
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Placebo Comparator: placebo high-intensity laser therapy group
Patients will receive placebo high-intensity laser therapy in addition to conventional treatment
|
The same treatment procedure will be applied in the placebo group as in the experimental group, but the laser device is turned off during applications, in addition to the conventional treatment in the form of hot pad, US, TENS, and exercise therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporalis and masseter muscles activity
Time Frame: within 8 weeks
|
The surface electromyography device (sEMG) (MyoTrac Infiniti 2 Channel sEMG w/Rehab Suite & Continence Suite-T9855; Quebec, Canada) at 60 Hz and Infiniti software will be used to record masseter and temporalis activity before and after the treatment program. patients will be instructed to clench to help the researcher to find the appropriate muscle location by their prominence. Pregelled and self-adhesive electrodes with 3 surface leads (2 recording, 1 reference) will be used. The electrode is placed over the anterosuperior to the angle of the mandible on both sides for recording masseter muscle, while for temporalis muscle, electrodes are placed above a line drawn from upper earline to canthus of the eye with interelectrode distance which is 8mm. sEMG Signal Analysis: Mean, median frequency, SD, root mean square, minimum, maximum, and range of muscle activity (μV) will be calculated. |
within 8 weeks
|
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Pain intensity
Time Frame: within 8 weeks
|
Visual analogue scale (VAS), a valid and reliable measure of pain intensity will be used to measure pain intensity for all participants in both groups before and after treatment.
All participants will be asked to mark their pain level on a 10-cm line that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain.
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within 8 weeks
|
|
Range of mouth opening
Time Frame: within 8 weeks
|
Flexible millimeter ruler will be used to measure mouth opening for all participants in both groups before and after the treatment.
Mouth opening will be evaluated by asking the patient to open their mouth as wide as possible and measuring the distance between the edges of the frontal incisors with a ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measured vertically to the labio-incisal edge of the opposing mandibular incisor to assess the pre-post therapy maximum mouth opening (MMO).
Studies reported range has been as wide as 32-62 mm (for both sexes)
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within 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ)
Time Frame: within 8 weeks
|
Arabic version of LDF-TMDQ will be used to assess the limitation of daily function in patients with temporomandibular dysfunction in both groups before and after the treatment program.
It consists of 10 items.
For each item, the subject chose any one of five levels on a numerical rating scale from no problem at all (0) to extremely difficult (4 points).
The total score of the 10 items, ranging from 0-40 points, will be analyzed.
Internal consistency of the total scores appeared to be good at 0.78 for the 10 items.
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within 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amir Saleh, professor, Cairo University
- Study Director: Naglaa Awais, PHD, Cairo University
- Study Director: Hala Hazzaa, professor, Al-Azhar University
- Study Director: Yasser Lasheen, PHD, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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