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临床试验/NCT03816709
NCT03816709已完成不适用

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

North Dakota State University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Heating Rate at 1.75 cm Depth

研究概览

简要总结

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.

详细描述

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:

  1. 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.

  2. A carpenter's square with markings along the vertical arm at the three experimental depths (1.0, 1.75, 2.5 cm) will be used.

  3. The horizontal arm of the carpenter's square will be covered in tape. The carpenter's square is then placed just proximal to the treatment mark while the level on the horizontal arm is used to maintain a level measure.

  4. Marks will be made on the muscle belly parallel to the marks on the vertical axis at 1.0, 1.75 and 2.5 cm depths.

  5. A mark is also made on the horizontal arm tape in line with the treatment mark on the medial gastrocnemius.

  6. 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.

  7. The thermocouples will be removed from the MetriCide after sterilizing for a minimum of 12 hours prior to insertion.

  8. The distal aspect of the thermocouple will be wiped dry with sterile gauze.

  9. A mark with a sharpie will be made on each thermocouple just past the length marked on the horizontal arm of the carpenter's square. This allows the tip of each thermocouple to be directly below the treatment site. A second mark will be made at 5 cm to make sure the thermocouple does not go too deep into the tissue.

  10. The distal end of the thermocouple will be wiped clean again using a 70% isopropyl alcohol wipe up to the marks and then the thermocouple will be wrapped in sterile gauze until it is inserted.

  11. 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. 5. The subject will be instructed to take two deep breaths, while the researcher lightly grasps the gastrocnemius to confirm muscle relaxation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Heating Rate at 1.75 cm Depth

时间窗: 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.

Heating Rate at 1 cm Depth

时间窗: 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.

Heating Rate at 2.5 cm Depth

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Gange

Associate Professor

North Dakota State University

研究点 (2)

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