Ultrasound Therapy; Complications Clinical Trial
Official title:
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
NCT number | NCT03816709 |
Other study ID # | HE19132 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 5, 2019 |
Est. completion date | May 11, 2020 |
Verified date | May 2021 |
Source | North Dakota State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the rate of tissue temperature increase in the triceps surae during an ultrasound treatment using the Chattanooga Intelect Legend XT. The following parameters will be used: 3 MHz frequency, 1.0 W/cm2 intensity, 15 minute treatment time. Thermocouples will be inserted at 1.0, 1.75, and 2.5 cm depths to determine the heating rates. Most modality textbook recommendations for therapeutic ultrasound are based on studies performed with the Omnisound ultrasound machine. Previous research has shown variations in power output across manufacturers, producing differences in tissue temperature increases. No information has been published regarding the heating rates of the Chattanooga Intelect Legend XT machine for ultrasound treatments. By determining the heating rates for this machine, clinicians will be better able to utilize the Chattanooga Intelect Legend XT to help reach therapeutic goals.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 11, 2020 |
Est. primary completion date | April 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - males and females between the ages of 18 - 35 years old - able to speak English - have less than 1 cm of adipose over the left medial gastrocnemius muscle. Exclusion Criteria: - any current lower extremity injury - any lower extremity injuries within the last 6 months - open wounds - skin infections - impaired circulation - peripheral vascular disease - deep vein thrombosis - advanced arthritis - poor thermal regulation - anesthetic areas - neoplasms/tumors - thrombophlebitis - closed infections - any allergies or sensitivities to betadine - any abnormalities observed in the medial gastrocnemius muscle determined by diagnostic ultrasound - 1.0 cm or greater adipose over the left medial gastrocnemius muscle. |
Country | Name | City | State |
---|---|---|---|
United States | North Dakota State University | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
North Dakota State University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heating Rate at 1 cm Depth | A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures. | Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes) | |
Primary | Heating Rate at 1.75 cm Depth | A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures. | Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes) | |
Primary | Heating Rate at 2.5 cm Depth | A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures. | Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment) |
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