The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

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: Completed
• Conditions: Massage
• Intervention / Treatment: Device: Quantifiable Soft Tissue Manipulation (QSTM)

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: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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.

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Phase I Stroke Pattern Characteristic Descriptions	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	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	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

Outcome Measure	Measure Description	Time Frame
(Phase III Only) Heart Rate	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	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	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.	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.	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	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	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	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)	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	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

• Sponsor: Indiana University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mary T Loghmani, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Soft tissue manipulation, massage
• Other Study ID 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