Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz

Study Overview
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Brief Summary
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Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.

Detailed Description
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See brief summary.

Official Title
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Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz

Conditions
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Adult Females, Bilateral Masseter Myalgia

Intervention / Treatment
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* Procedure: Therapeutic ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult females Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria An average pain of 5 or more on a 0 to 10 scale over the last 30 days. Exclusion Criteria: A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). Certain conditions such as neoplasms or fractures. Neuropathies or neurological disorders. Currently taking muscle relaxants or analgesics. Undergone any form of physical therapy within the last 60 days. Severe bruxism requiring mouth-guard treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The 1 MHz group<br>The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting. | Procedure: Therapeutic ultrasound<br>* A commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle.<br>|
| Experimental: The 3 MHz group<br>The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting. | Procedure: Therapeutic ultrasound<br>* A commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in masseter pain by visual analog pain scale. | Reduction in masseter pain as measured on a visual analog scale (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable). | Baseline to fifth week. | 
| Reduction in masseter pain by pressure pain threshold. | Reduction in masseter pain as measured with the pressure pain threshold (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable).. | Baseline to fifth week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorders, masseter myalgia, adult female