Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

Completed · Not applicable · Has a placebo group

Conditions studied: Temporomandibular Joint Dysfunction Syndrome

In brief

This study will compare ultrasound 0.4 W/cm\^2 and 100% duty cycle versus no ultrasound (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the subject and ultrasound operator will be blind to the dose. The outcome measures will be pressure pain threshold on both masseter muscles and both temporalis muscles, self reported pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and intraoral temperature. These outcome measures will be taken before and after each dose, so three times per subject.

Key facts

Study ID

NCT02892994

Run by

State University of New York at Buffalo

People needed

23

Starts

2016-04-01

Expected to finish

2016-06-01

Last updated by the study team

2016-09-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult females Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) (Schiffman, et al., 2014) Current pain intensity ≥4 out of 10, (where 0 is no pain and 10 is the worst pain ever) on both sides.

You may not qualify if…

• History or diagnosis of systemic musculoskeletal disorders. Rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). Certain conditions such as neoplasms or fractures. Neuropathies or neurological disorders. Currently taking muscle relaxants or analgesics. Any form of physical therapy within the last 60 days.

Where it is running

• School of Dental Medicine — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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