Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound.

CONTEXT: The heating characteristics of a stationary device delivering sustained acoustic medicine with low-intensity therapeutic ultrasound (LITUS) are unknown. OBJECTIVE: To measure intramuscular (IM) heating produced by a LITUS device developed for long-duration treatment of musculoskeletal injuries. DESIGN: Controlled laboratory study. SETTING: University research laboratory. PATIENTS OR OTHER PARTICIPANTS: A total of 26 healthy volunteers (16 men, 10 women; age = 23.0 ± 2.1 years, height = 1.74 ± 0.09 m, mass = 73.48 ± 14.65 kg). INTERVENTION(S): Participants were assigned randomly to receive active (n = 20) or placebo (n = 6) LITUS at a frequency of 3 MHz and an energy intensity of 0.132 W/cm(2) continuously for 3 hours with a single transducer or dual transducers on the triceps surae muscle. We measured IM temperature using thermocouples inserted at 1.5- and 3-cm depths into muscle. Temperatures were recorded throughout treatment and 30 minutes posttreatment. MAIN OUTCOME MEASURE(S): We used 2-sample t tests to determine the heating curve of the LITUS treatment and differences in final temperatures between depth and number of transducers. RESULTS: A mild IM temperature increase of 1 °C was reached 10 ± 5 minutes into the treatment, and a more vigorous temperature increase of 4 °C was reached 80 ± 10 minutes into the treatment. The maximal steady-state IM temperatures produced during the final 60 minutes of treatment at the 1.5-cm depth were 4.42 °C ± 0.08 °C and 3.92 °C ± 0.06 °C using 1 and 2 transducers, respectively. At the 3.0-cm depth, the maximal steady-state IM temperatures during the final 60 minutes of treatment were 3.05 °C ± 0.09 °C and 3.17 °C ± 0.05 °C using 1 and 2 transducers, respectively. We observed a difference between the temperatures measured at each depth (t78 = -2.45, P = .02), but the number of transducers used to generate heating was not different (t78 = 1.79, P = .08). CONCLUSIONS: The LITUS device elicited tissue heating equivalent to traditional ultrasound but could be sustained for multiple hours. It is a safe and effective alternative tool for delivering therapeutic ultrasound and exploring dosimetry for desired physiologic responses.

Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis.

Osteoarthritis is one of the leading causes of disability in the aging population. Long duration, low intensity therapeutic ultrasound has had promising impact in animal models to slow the progression of the disease and provide joint relief. Two pilot studies were conducted using a novel, wearable platform for delivering ultrasound to evaluate the potential clinical benefits of ultrasound therapy on knee osteoarthritis. There was a pain reduction effect from using ultrasound, as high as fifty two percent in one study. As well, initial data demonstrates that mobility may be increased for patients experiencing mild to moderate arthritis of the knee.

Human Factors Engineering and testing for a wearable, long duration ultrasound system self-applied by an end user.

One of the major challenges in the design of a new class of medical device is ensuring that the device will have a safe and effective user interface for the intended users. Human Factors Engineering addresses these concerns through direct study of how a user interacts with newly designed devices with unique features. In this study, a novel long duration, low intensity therapeutic ultrasound device is tested by 20 end users representative of the intended user population. Over 90% of users were able to operate the device successfully. The therapeutic ultrasound device was found to be reasonably safe and effective for the intended users, uses, and use environments.