Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

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

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.

Study Overview

• Status: Completed
• Conditions: Asymptomatic Condition
• Intervention / Treatment: Procedure: Graston Instrument assisted Soft tissue Mobilization

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33965
      • Florida Gulf Coast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graston effect medial arch, plantar fascia, and trapezius; Pre and post Graston change in blood flow at the medial arch foot, plantar fascia, and the trapezius region	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Collaborators: Thomas Zeller; Tyler Corbin; Alyssa Nieves

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Instrument assisted soft tissue mobilization; Musculoskeletal Ultrasound Imaging; Bood circulation; Perception
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Asymptomatic Diseases
• Other Study ID Numbers: 2020-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No