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Completed

NCT Number: NCT04785079

Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

This study is designed to evaluate the short term change in blood flow in the superficial human tissue layers after the application of 3 min Graston instrumented assisted soft tissue mobilization on the plantar aspect of the foot and the trapezius muscle.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Gulf Coast University

Fort Myers, Florida, 33965, United States

About this study

Instrument assisted soft tissue mobilization (IASTM) is a commonly used physical therapy intervention. Graston ® technique is a form of IASTM that requires completion of a certification course and utilizes specific stainless-steel tools. IASTM has been found to improve range of motion, pain and patient reported function in pathological individuals. One method by which these improvements are thought to occur is by increasing blood flow. Increased blood flow brings nutrients and oxygen to the area and is thought to contribute to tissue remodeling. There is very limited research investigating blood flow changes following IASTM. In order to measure blood flow changes following IASTM, doppler ultrasound may be used. There are no studies to our knowledge quantifying changes in blood flow following IASTM using ultrasound. Power doppler approximates perfusion by detecting a frequency shift from movement of red blood cells and color is then encoded proportionally to the number of red blood cells. Power doppler imaging quantification (PDIQ) is a feature of musculoskeletal ultrasound (MSK) that compares the number of color pixels and the intensity of color within these pixels to grey scale pixels within a given image. The aim of this study is to determine if there is an increase in blood flow in the trapezius, plantar fascia and medial arch of the foot measured following IASTM. Blood flow was measured by using PDIQ ratio in the doppler setting of MSK ultrasound.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A-symptomatic individuals over the age of 18

Exclusion criteria

  • Anyone under 18 and anyone with any conditions contraindicated for IASTM including compromised tissue integrity, deep vein thrombosis (DVT), area of infection in the treatment area, or acute fracture.

Treatment and study plan

Graston Instrument assisted Soft tissue Mobilization

Procedure

Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations

Primary outcomes

  1. GE LOGIQe ultrasound machine to measure maximum power doppler imaging quantification (PDIQ) ratios

    Time frame: One day measure-First measure will be taken before the treatment intervention, immediate after the intervention and three minutes afterward. Total time for the experiment is 15 minutes

    ultrasound images are used to calculate the ratio of color to grey scale pixels called the power doppler quantification ratio (PDIQ).

Sponsors and collaborators

Lead sponsor

Florida Gulf Coast University

Other

Collaborators

  • Alyssa Nieves
  • Thomas Zeller
  • Tyler Corbin

Registry information

Official study title

Qualification of Instrument Assisted Soft Tissue Mobilization Induced Hyperemia Using Musculoskeletal Ultrasound

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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