NCT03816709 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Draper DO, Castel JC, Castel D
Rate of temperature increase in human muscle during 1 MHz and 3 MHz continuous ultrasound. J Orthop Sports Phys Ther. 1995 Oct;22(4):142-50.
Gange KN, Kjellerson MC, Berdan CJ
The Dynatron Solaris® Ultrasound Machine: Slower Heating Than Textbook Recommendations at 3 MHz, 1.0 W/cm(2). J Sport Rehabil. 2018 Jan 1;27(1):22-29. doi: 10.1123/jsr.2016-0173. Epub 2018 Jan 18.
Merrick MA, Bernard KD, Devor ST, Williams MJ
Identical 3-MHz ultrasound treatments with different devices produce different intramuscular temperatures. J Orthop Sports Phys Ther. 2003 Jul;33(7):379-85.

Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound With 3 MHz, 1.0 W/cm2 at Three Depths up to 2.5 cm

Clinical trial NCT03816709 - References