Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound

NCT03816709 | Completed Results FDA Device

• 1 other identifier: HE19132
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound Therapy; Complications

Keywords

heating rates; therapeutic ultrasound

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Therapeutic ultrasound treatment

OTHER

All subjects received a therapeutic ultrasound treatment with the Chattanooga Intelect Legend XT machine with the following parameters: 3 MHz, 1.0 W/cm2, 15 minute treatment time.

Device: Therapeutic Ultrasound

Interventions

Therapeutic Ultrasound DEVICE

A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.

Also known as: Ultrasound therapy

Therapeutic ultrasound treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• North Dakota State University: lead

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108-6050, United States

Location

Related Publications (3)

• Gange KN, Kjellerson MC, Berdan CJ. The Dynatron Solaris(R) Ultrasound Machine: Slower Heating Than Textbook Recommendations at 3 MHz, 1.0 W/cm2. J Sport Rehabil. 2018 Jan 1;27(1):22-29. doi: 10.1123/jsr.2016-0173. Epub 2018 Jan 18.

  PMID: 27992304 BACKGROUND

• 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. doi: 10.2519/jospt.2003.33.7.379.

  PMID: 12918863 BACKGROUND

• 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. doi: 10.2519/jospt.1995.22.4.142.

  PMID: 8535471 BACKGROUND

MeSH Terms

Interventions

Ultrasonic Therapy

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Results Point of Contact

• Title: Kara Gange, Associate Professor
• Organization: North Dakota State University

kara.gange@ndsu.edu

701-231-5777

Study Officials

• Kristy Shirley

  NDSU IRB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: February 5, 2019
• Primary Completion: April 15, 2020
• Study Completion: May 11, 2020
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)