Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

NCT ID: NCT04785079

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asymptomatic Condition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Quasi-experimental study using a single group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Graston Instrument assisted Soft tissue Mobilization

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas Zeller

UNKNOWN

Sponsor Role collaborator

Tyler Corbin

UNKNOWN

Sponsor Role collaborator

Alyssa Nieves

UNKNOWN

Sponsor Role collaborator

Florida Gulf Coast University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Rob Sillevis,

Assistent Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Gulf Coast University

Fort Myers, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-34

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stretching and Musculoskeletal Pain
NCT04617379 COMPLETED NA
Ankle Sprains and Corticospinal Excitability
NCT00847769 COMPLETED PHASE1/PHASE2