NCT03816709

Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound

Completed NA Results posted Last updated 27 May 2021

What this trial tests

NA trial testing Therapeutic Ultrasound in Ultrasound Therapy; Complications in 25 participants. Completed in 11 May 2020.

Timeline

5 February 2019

Primary endpoint
15 April 2020

11 May 2020

Quick facts

Lead sponsor	North Dakota State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	25
Start date	5 February 2019
Primary completion	15 April 2020
Estimated completion	11 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Therapeutic Ultrasound

Conditions studied

• Ultrasound Therapy; Complications — all drugs for Ultrasound Therapy; Complications →

Sponsor

North Dakota State University

Who can join

Adults 18 to 35, any sex, with Ultrasound Therapy; Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Heating Rate at 1 cm Depth Primary · Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)

A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.

Group	Value	95% CI
Therapeutic Ultrasound Treatment	6.49	± 1.24

Heating Rate at 1.75 cm Depth Primary · Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes)

A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.

Group	Value	95% CI
Therapeutic Ultrasound Treatment	5.50	± 1.34

Heating Rate at 2.5 cm Depth Primary · Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment)

A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.

Group	Value	95% CI
Therapeutic Ultrasound Treatment	3.07	± 1.53

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.