## Protocol Section
### Identification Module
**NCT ID:** NCT04785079

**Brief Title:** Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

**Official Title:** Qualification of Instrument Assisted Soft Tissue Mobilization Induced Hyperemia Using Musculoskeletal Ultrasound

#### Organization Study ID Info
**ID:** 2020-34
#### Organization
**Class:** OTHER
**Full Name:** Florida Gulf Coast University
### Status Module
#### Completion Date
**Date:** 2022-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-27

**Type:** ACTUAL

**Last Update Submit Date:** 2022-07-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-08-01

**Type:** ACTUAL

**Status Verified Date:** 2022-07

#### Study First Post Date
**Date:** 2021-03-05
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-01
**Study First Submit QC Date:** 2021-03-03
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Thomas Zeller

**Class:** UNKNOWN

**Name:** Tyler Corbin

**Class:** UNKNOWN

**Name:** Alyssa Nieves

#### Lead Sponsor

**Class:** OTHER

**Name:** Florida Gulf Coast University

#### Responsible Party

**Investigator Affiliation:** Florida Gulf Coast University

**Investigator Full Name:** Dr. Rob Sillevis,

**Investigator Title:** Assistent Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Asymptomatic Condition

**Keywords:**

- Instrument assisted soft tissue mobilization

- Musculoskeletal Ultrasound Imaging

- Bood circulation

- Perception

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Quasi-experimental study using a single group

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pre and post Graston change in blood flow at the medial arch foot, plantar fascia, and the trapezius region

**Intervention Names:**

- Procedure: Graston Instrument assisted Soft tissue Mobilization

**Label:** Graston effect medial arch, plantar fascia, and trapezius

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Graston effect medial arch, plantar fascia, and trapezius

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

**Name:** Graston Instrument assisted Soft tissue Mobilization

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fort Myers

**Country:** United States

**Facility:** Florida Gulf Coast University

**State:** Florida

**Zip:** 33965

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M28968

- Name: Asymptomatic Diseases

- Relevance: HIGH

- As Found: Asymptomatic Condition

- ID: M9991

- Name: Hyperemia

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058070

- Term: Asymptomatic Diseases

### Misc Info Module

- Version Holder: 2024-05-24
