The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

Completed

• Conditions: Massage
• Interventions: Device: Quantifiable Soft Tissue Manipulation (QSTM)

• Registration Number: NCT04923633
• Lead Sponsor: Indiana University

Brief 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. 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.

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 Timeline

• Study First Submitted: 2021-04-23
• Study Start: 2021-05-11
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Primary Completion: 2022-10-19
• Study Completion: 2022-10-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase III Reliability of Dynamic Pressure Pain Threshold Assessment	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.

Primary Outcome Measures

Name	Time	Method
Phase I Stroke Pattern Characteristic Descriptions	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 III Reliability of Dynamic Pressure Pain Threshold Assessment	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.
Phase II Reliability of IASTM Force Application	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).

Secondary Outcome Measures

Name	Time	Method
(Phase III Only) Strength	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.
(Phase III Only) Vertical Jump Test	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
(Phase III Only) Blood Pressure	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.
(Phase III Only) Hamstring Length Flexibility Test.	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.
(Phase III Only) Trunk Forward Bend Flexibility Test.	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).
(Phase III Only) Static Pressure Pain Threshold	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.
(Phase III Only) Range of Motion	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.
(Phase III Only) Heart Rate	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).
(Phase III Only) Skin Surface Temperature	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.
(Phase III Only) 10-Meter Walk Test (10-MWT)	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.

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States