Adult Females, Bilateral Masseter Myalgia
Conditions
Keywords
temporomandibular disorders, masseter myalgia, adult female
Brief summary
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
See brief summary.
Interventions
PROCEDURETherapeutic ultrasound
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.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The frequency setting on the ultrasound machine will be set and known only to the principal investigator.
Intervention model description
Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in masseter pain by visual analog pain scale. | Baseline to fifth week. | 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). |
| Reduction in masseter pain by pressure pain threshold. | Baseline to fifth week. | 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).. |
Countries
United States
Outcome results
None listed