ClinicalTrials.gg
CompletedNCT04785079Updated Jul 27, 2022

Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

An interventional study of Graston Instrument assisted Soft tissue Mobilization in Asymptomatic Condition, sponsored by Florida Gulf Coast University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-27.

Sponsored by Florida Gulf Coast University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asymptomatic Condition

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Keywords

  • Instrument assisted soft tissue mobilization
  • Musculoskeletal Ultrasound Imaging
  • Bood circulation
  • Perception
03

In context

Asymptomatic Diseases

38 studies on the registry are indexed under Asymptomatic Diseases; 8 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 28 interventional studies indexed under Asymptomatic Diseases.

Browse Asymptomatic Diseases studies →

Lead sponsor

Florida Gulf Coast University is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A-symptomatic individuals over the age of 18

Exclusion criteria

Exclusion Criteria:

  • Anyone under 18 and anyone with any conditions for IASTM including compromised tissue integrity, deep vein thrombosis (DVT), area of infection in the treatment area, or acute fracture.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureGraston 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

06

What researchers measure

Primary outcomes

  1. 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).

    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

07

Study locations

1 site
  • Florida Gulf Coast University
    Fort Myers, Florida 33965, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2020 to primary completion in Mar 2022, 19 months.

Of 17 interventional studies with no phase under Asymptomatic Diseases, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 19 months is above that.

Asymptomatic Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2021
First posted
Mar 5, 2021
StartActual
Aug 1, 2020
Primary completionActual
Mar 1, 2022
CompletionActual
Mar 1, 2022
Last update
Jul 27, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04785079
Lead sponsor
Florida Gulf Coast University
Collaborators
Thomas Zeller, Tyler Corbin, Alyssa Nieves
Responsible party
Dr. Rob Sillevis, (Assistent Professor, Florida Gulf Coast University) — Principal investigator
First posted
Mar 5, 2021
Start date
Aug 1, 2020
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Jul 27, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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