Trial Outcomes & Findings for Intramuscular Heating Rates of a Chattanooga Intelect XT Therapeutic Ultrasound (NCT NCT03816709)
NCT ID: NCT03816709
Last Updated: 2021-05-27
Results Overview
A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.
COMPLETED
NA
25 participants
Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)
2021-05-27
Participant Flow
Twenty-five subjects were recruited through the Institution's Listserve from January-February, 2019.
Participant milestones
| Measure |
Therapeutic Ultrasound Treatment
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.
Therapeutic Ultrasound: 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.
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|---|---|
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Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Therapeutic Ultrasound Treatment
n=25 Participants
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.
Therapeutic Ultrasound: 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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=25 Participants
|
|
Region of Enrollment
United States
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25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes)Population: Intent to treat population. All subjects received the Ultrasound treatment with a thermocouple recording tissue temperatures at the 1 cm depth.
A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures.
Outcome measures
| Measure |
Therapeutic Ultrasound Treatment
n=25 Participants
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.
Therapeutic Ultrasound: 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 at the depths of 1.0, 1.75, and 2.5 cm.
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|---|---|
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Heating Rate at 1 cm Depth
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6.49 degrees Celcius
Standard Deviation 1.24
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PRIMARY outcome
Timeframe: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 8 minutes)Population: Intent to treat. All subject received the Ultrasound treatment with a thermocouple at the 1.75 cm depth to determine tissue temperature
A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures.
Outcome measures
| Measure |
Therapeutic Ultrasound Treatment
n=25 Participants
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.
Therapeutic Ultrasound: 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 at the depths of 1.0, 1.75, and 2.5 cm.
|
|---|---|
|
Heating Rate at 1.75 cm Depth
|
5.50 degrees Celcius
Standard Deviation 1.34
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which did not occur in the 15 minute treatment)Population: Intent to treat. All subjects received the Ultrasound treatment with a thermocouple at the 2.5 cm depth to determine tissue temperatures.
A thermocouple was inserted at the 2.5 cm depth to determine the tissue temperatures.
Outcome measures
| Measure |
Therapeutic Ultrasound Treatment
n=25 Participants
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.
Therapeutic Ultrasound: 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 at the depths of 1.0, 1.75, and 2.5 cm.
|
|---|---|
|
Heating Rate at 2.5 cm Depth
|
3.07 degrees Celcius
Standard Deviation 1.53
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Adverse Events
Therapeutic Ultrasound Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kara Gange, Associate Professor
North Dakota State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place