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Completed

NCT Number: NCT04923633

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

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;
  • 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.

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Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. (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).

  2. (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.

  3. (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.

  4. (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.

  5. (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).

  6. (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.

  7. (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.

  8. (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.

  9. (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.

  10. (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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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