Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

Asymptomatic Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785079
• Other study ID #: 2020-34
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Florida Gulf Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases

Intervention

Procedure:
• Graston Instrument assisted Soft tissue Mobilization
Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations

Locations

Country	Name	City	State
United States	Florida Gulf Coast University	Fort Myers	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Florida Gulf Coast University	Alyssa Nieves, Thomas Zeller, Tyler Corbin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GE LOGIQe ultrasound machine to measure maximum power doppler imaging quantification (PDIQ) ratios	ultrasound images are used to calculate the ratio of color to grey scale pixels called the power doppler quantification ratio (PDIQ).	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