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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.
Individual subjects will report to the research lab. They will be instructed to wear appropriate shorts or pants that can be rolled up to expose the gastrocnemius (calf) muscle. The subject will lay prone on the treatment table with the foot and lower leg off of the treatment table in a relaxed, comfortable position. The following procedures will be completed using universal precautions:
The investigator will prep the treatment area by having the subject flex the calf to determine the proper location for the ultrasound treatment in the middle of the medial gastrocnemius muscle belly at its largest girth.
The Terason uSmart 3300 diagnostic ultrasound unit will be used to measure the adipose thickness over the treatment area and look for abnormalities in the treatment and thermocouple insertion areas. Aquasonic® 100 ultrasound gel will be placed on the 15L4 transducer. The transducer with gel will be placed over the mark of the treatment area. Once the transducer is in place, the screen will be frozen and the skin and adipose thickness will be measured using the caliper tool.
The thermocouples will be removed from the MetriCide after sterilizing for a minimum of 12 hours prior to insertion.
The insertion areas will be shaved to remove any body hair (if necessary) and cleaned using Betadine.
a. Once the Betadine dries, 70% isopropyl alcohol will be wiped over the insertion area and given time to dry.
The subject will be instructed to take two deep breaths, while the researcher lightly grasps the gastrocnemius to confirm muscle relaxation.
Each thermocouple will be attached to the Iso Thermex electronic thermometer (Columbus Instruments, Columbus, OH), which will measure and record intramuscular temperatures from the tips of the thermocouples.
An ultrasound treatment template will be applied at the treatment site and secured with tape to maintain consistent treatment size.
a. This template will be twice the size of the transducer's Effective Radiating Area (ERA).
A metronome will be utilized to consistently move the transducer at a rate of 4 cm/s .
The ultrasound treatment will begin once the intramuscular temperature has remained the same for a minute.
Each subject will receive one ultrasound treatment at the following parameters: 3 MHz frequency, 1.0 W/cm2 intensity, and 100% duty cycle using the Chattanooga Intelect® Legend XT.
a. Termination of treatment will result when any of the following occur: i. A 15-minute treatment time is obtained. ii. A 4°C temperature increase occurs at all three depths as this has been shown as the necessary temperature change to increase tissue extensibility.
iii. A 45°C temperature is reached at any depth, due to concern of tissue damage at high temperatures.
iv. The subject experiences any pain or discomfort during the treatment.
Following the treatment, the ultrasound gel will be wiped from the leg, the template and thermocouples will be removed, and the insertion sites will be cleaned with 70% isopropyl alcohol wipes and covered with a band aid.
The subject will then be instructed on the possibility of minor soreness for the next day or two and instructed on an icing schedule to decrease discomfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristy Shirley | NDSU IRB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Dakota State University | Fargo | North Dakota | 58108-6050 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27992304 | Background | 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. | |
| 12918863 | 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. |
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Once the data has been analyzed to determine the heating rates, a manuscript including the heating rates will be submitted for publication.
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Twenty-five subjects were recruited through the Institution's Listserve from January-February, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
male and female 18-35 year olds with no injuries to the lower leg.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18-35 year olds |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heating Rate at 1 cm Depth | A thermocouple was inserted at the 1 cm depth to determine the tissue temperatures. | Intent to treat population. All subjects received the Ultrasound treatment with a thermocouple recording tissue temperatures at the 1 cm depth. | Posted | Mean | Standard Deviation | degrees Celcius | Baseline to end of treatment (up to 15 minutes or until temperatures increased 4 degrees, which occurred at 6 minutes) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 at the depths of 1.0, 1.75, and 2.5 cm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Gange, Associate Professor | North Dakota State University | 701-231-5777 | kara.gange@ndsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 22, 2019 | May 4, 2021 | Prot_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | May 4, 2021 | SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 22, 2019 | May 4, 2021 | ICF_007.pdf |
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| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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|
| 8535471 | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Heating Rate at 1.75 cm Depth | A thermocouple was inserted at the 1.75 cm depth to determine the tissue temperatures. | Intent to treat. All subject received the Ultrasound treatment with a thermocouple at the 1.75 cm depth to determine tissue temperature | Posted | Mean | Standard Deviation | degrees Celcius | 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. | Intent to treat. All subjects received the Ultrasound treatment with a thermocouple at the 2.5 cm depth to determine tissue temperatures. | Posted | Mean | Standard Deviation | degrees Celcius | 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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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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