The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

November 13, 2023 updated by: Mary T. Loghmani, Indiana University

The overall purpose of this study is to objectively describe and test the consistency and reproducibility of instrument-assisted soft tissue manipulation (IASTM).The specific aims of this current study are to:

  1. Analyze IASTM stroke patterns using objective metrics;
  2. Test the consistency of force application, with and without visual monitoring of objective metrics, and;
  3. Determine the reliability of dynamic pressure pain threshold assessment. The ultimate goal of this continuing line of research is to improve soft tissue manual therapy practice in research, education, and clinic for use as a non-invasive modality in soft tissue assessment and treatment. Results from this protocol will inform future clinical trials, including studies exploring the effects of different IASTM dose-loads in various musculoskeletal pain conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-site study consisting of three study phases. Phase I will observe and analyze clinician's application of instrument-assisted soft tissue manipulation (IASTM) as a means to identify signature profiles for the stroke rate, angle, and direction that are characteristic of basic (e.g., linear, curved) stroke patterns. Phase II will assess the consistency of IASTM force application. Phase III will assess the reliability of dynamic pressure pain threshold assessment. Clinician participants (Phase I) will attend one study visit consisting of basic linear and curved IASTM stroke pattern applications and complete a questionnaire. Total study duration for clinician participants will be 90 minutes. Non-clinician subjects will attend two study visits (Phase II) or one study visit (Phase III). Visits will consist of completion of questionnaires, application of IASTM strokes by a clinician using the QSTM device, and stretching.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy, males and females, ages 18-75.

Description

Inclusion Criteria:

Phase I

  1. Male or female between the ages of 18-75 years old.
  2. Be a licensed, practicing healthcare clinician (e.g. physical therapist, massage therapist, osteopathic physician, athletic trainer, chiropractor)
  3. Have at least 8 years of clinical experience in instrument-assisted soft tissue manual therapy

Phase II

  1. Male and female subjects between 18-75 years old
  2. Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2

Phase III

  1. Male and female subjects, ages younger (≥18 but ≤30yo) and older (≥50 but ≤75yo)
  2. Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2

Exclusion Criteria:

Phase I

  1. <8 years of clinical experience in instrument-assisted soft tissue manual therapy practice
  2. Any known pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or any other inflammatory conditions that could interfere with the participant's ability to perform basic IASTM stroke patterns.
  3. Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.

Phase II

  1. Known cardiovascular, pulmonary, or metabolic disease;
  2. Current smoking or those who quit smoking within the previous 6 months;
  3. Current use of anti-inflammatory or analgesics;
  4. Any history of back, neck, lower extremity, or abdominal surgery or injury; or back, neck, or leg pain within the previous 6 months that impaired function;
  5. Any co-morbidities that could contribute to back, neck, or leg pain (e.g., radiculopathies, rheumatoid arthritis, osteoarthritis, inflammatory conditions).

Phase III 1. The same exclusion criteria as for Phase II.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Phase I Instrument-Assisted Soft Tissue Manipulation (IASTM) Stroke Pattern Analysis
Fifteen (n=15) experienced clinicians, each with 8 or more years experiences in instrument-assisted soft tissue manipulation (IASTM), will participate in an observational studying analyzing their application of basic stroke patterns (linear, curved) to a consistent research assistant/model. IASTM is a type of massage that uses rigid devices. A Quantifiable Soft Tissue Manipulation (QSTM) device system will be used for determining objective metrics of stroke parameters (e.g. stroke force, rate, angle) and results will be compared between participants to determine characteristic stroke profile patterns for use in training and research.
Phase II Consistency of IASTM Force Application
The reproducibility of applying a targeted STM stroke force will be determined within and between therapists, both with and without visual monitoring of the QSTM metrics and graphic display. Two novice and two experienced therapists will be trained using QSTM. A novice is defined as a clinician with <1 year and an experienced with >8 years of practice. Fifty (n=50) healthy, non-obese subjects will be enrolled that meet the inclusion/exclusion criteria. First, the clinicians will apply a self-perceived "moderate" force for 15sec (non-therapeutic dose), within subject tolerance, without using QSTM feedback. Then, the clinician will apply a targeted force of 10N with visual monitoring of QSTM feedback. This process will be repeated 5-7 days later to determine repeatability. After testing, subjects will participate in simple back and/or leg stretches and an ice pack applied.
Phase III Reliability of Dynamic Pressure Pain Threshold Assessment
The reliability of dynamic pressure pain threshold (DPPT) assessment over a specified area will be determined. Two novice and two experienced clinicians will be trained using QSTM. Subjects (n=50) will be recruited that meet the inclusion/exclusion criteria of healthy, non-obese, younger (≥18 but ≤30yo) and older individuals (≥50 but ≤75yo) (males and females). The clinicians will apply force to standardized areas of the back and thigh regions for 1 min, using the Quantifiable Soft Tissue Manipulation (QSTM) device system. The force applied will be applied up to but below the threshold of when a subject says to "stop" when they feel the "pressure" change into any sort of "irritating discomfort/pain." Secondary clinical outcomes will be assessed before and after testing since testing could have effects on the soft tissue, pain, and physical performance measures. After testing, the subject will be instructed in simple back and/or leg stretches and an ice pack applied.
Device: Quantifiable Soft Tissue Manipulation (QSTM)
Quantifiable soft tissue manipulation (QSTM) is a force sensing device system that can be used by a clinician to apply a massaging force while the system monitors objective metrics, i.e., the amount, rate, and angle of force applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase I Stroke Pattern Characteristic Descriptions
Time Frame: Analysis results within 6 months.
The objectives metrics from quantifiable soft tissue manipulation device system will be analyzed for common or characteristic applications between clinicians.
Analysis results within 6 months.
Phase II Reliability of IASTM Force Application
Time Frame: Measured within 2 hours for same day reliability and at 7 days for between day reliability. Results reported by end of study at one year
The agreement in soft tissue manipulation force application, between and within clinicians, will be determined within a single session and between session (within 7 days apart).
Measured within 2 hours for same day reliability and at 7 days for between day reliability. Results reported by end of study at one year
Phase III Reliability of Dynamic Pressure Pain Threshold Assessment
Time Frame: Measured within 2 hours on same day of testing. Results reported by end of study at one year.
The agreement between and within clinicians in pressure pain threshold assessment over a body area will be determined within a single session.
Measured within 2 hours on same day of testing. Results reported by end of study at one year.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
(Phase III Only) Heart Rate
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Radial pulse will be palpated to determine heart rate (in beats per minute, BPM).
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Blood Pressure
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Will determine systolic and diastolic blood pressure (in mmHg) using a stethoscope and sphygmomanometer.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Range of Motion
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Will measure the amount (range) of trunk movement (in degrees) using a modified protractor.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Hamstring Length Flexibility Test.
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Will measure the amount (range) of passive knee extension movement available (in degrees) with the hip stabilized at 90 degrees using a modified protractor.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Trunk Forward Bend Flexibility Test.
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
A tape measurer/ruler will be used to determine the extensibility (e.g. limberness) of the posterior (back) trunk soft tissues during seated trunk forward bend (reaching) muscle length test (change from start to end of test measured in centimeters).
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Strength
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
A handheld dynamometer will be used to test the strength (Newtons of force) of the subject's back and thigh.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Static Pressure Pain Threshold
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
This test will determine a subject's pressure pain sensitivity in a single spot using a non-invasive device, i.e. static algometer.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Skin Surface Temperature
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Changes in skin surface temperature will be determined using an infrared thermometer of the skin are where IASTM is applied on the back and thigh.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) 10-Meter Walk Test (10-MWT)
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Maximal walking speed (MWS) (in meters/sec) will be determined using the 10-meter walk test as a functional performance measure.
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Vertical Jump Test
Time Frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
The vertical jumping height (in centimeters) (only in subjects 18-30 y.o.) will be determined as a functional performance measure
Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary T Loghmani, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10329 (Other Identifier: CTEP)
  • R41AT011494 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request.

IPD Sharing Time Frame

After July 31, 2022 for one year

IPD Sharing Access Criteria

Other research institution PI or as requested upon review.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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