MassageNCT04923633

The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

An observational study of Massage, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Massage
What is being tested?: Quantifiable Soft Tissue Manipulation (QSTM)
Type of treatment: Medical device
How many people: 106 participants
Where: 1 siteUnited States
Study dates: 11 May 2021to 19 Oct 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Adult, Older adult

Study population: Healthy, males and females, ages 18-75.

Who may be able to join

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

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

Who cannot join

Phase I
<8 years of clinical experience in instrument-assisted soft tissue manual therapy practice
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.
Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.
Phase II
Known cardiovascular, pulmonary, or metabolic disease;

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Current smoking or those who quit smoking within the previous 6 months;
Current use of anti-inflammatory or analgesics;
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;
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.
-

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Analyze IASTM stroke patterns using objective metrics;
Test the consistency of force application, with and without visual monitoring of objective metrics, and;
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.

Read the 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.

Conditions: Massage
Being tested: Quantifiable Soft Tissue Manipulation (QSTM)
Keywords: Soft tissue manipulation, massage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quantifiable Soft Tissue Manipulation (QSTM)Device
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.

Study groups in NCT04923633
Study group	Role	What they receive
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. Receives: Device: Quantifiable Soft Tissue Manipulation (QSTM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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: 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: Measured within 2 hours on same day of testing. Results reported by end of study at one year.

Secondary outcomes (10)

(Phase III Only) Heart Rate
Radial pulse will be palpated to determine heart rate (in beats per minute, BPM).
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202119 Oct 2022

First posted11 Jun 2021
Study start11 May 2021
Primary completion19 Oct 2022
Study completion19 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MassageStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04923633
Sponsor's protocol ID: 10329
Other IDs: R41AT011494
Status last verified: Nov 2023
First submitted: 23 Apr 2021
Last updated: 14 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: Upon request.

Publications

Loghmani MT, Powell R, Eckert GJ, Morgan S, Bhattacharjee A, Chien S, Anwar S. Visual monitoring in real-time improves consistency of 3D IASTM force applied to humans. Chiropr Man Therap. 2026 Jul 23;34(1):28. doi: 10.1186/s12998-026-00668-6.
PubMed 42522020

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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All Massage trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation
ClinicalTrials.gov ID: NCT04923633
Acronym / sponsor ID: 10329
Conditions: Massage
Keywords: Soft tissue manipulation, massage
Study type: Observational
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 11 May 2021 (actual)
Primary completion: 19 Oct 2022 (actual)
Study completion: 19 Oct 2022 (actual)
First posted: 11 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Analyze IASTM stroke patterns using objective metrics;
Test the consistency of force application, with and without visual monitoring of objective metrics, and;
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.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
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	–	Device: Quantifiable Soft Tissue Manipulation (QSTM)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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Age groups: Adult, Older adult
Study population: Healthy, males and females, ages 18-75.

Key inclusion criteria (10 listed)

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

Key exclusion criteria (12 listed)

Phase I
<8 years of clinical experience in instrument-assisted soft tissue manual therapy practice
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.
Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.
Phase II

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Phase III Reliability of Dynamic Pressure Pain Threshold Assessment

Primary outcome

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.
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).
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.

10 secondary outcomes

(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Derived from this study: PubMed 42522020Loghmani MT, Powell R, Eckert GJ, Morgan S, Bhattacharjee A, Chien S, Anwar S. Visual monitoring in real-time improves consistency of 3D IASTM force applied to humans. Chiropr Man Therap. 2026 Jul 23;34(1):28. doi: 10.1186/s12998-026-00668-6.
Individual participant dataSharing planned: Yes. Upon request.

Related trials for Massage

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Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary T Loghmani, PhD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Massage, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I Stroke Pattern Characteristic Descriptions (time frame: Analysis results within 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.