Clinical trial NCT04923633: The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation
Official title: The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Massage
Keywords: Soft tissue manipulation, massage
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-06-11
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, males and females, ages 18-75.

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.

Eligibility criteria: 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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Primary outcomes:
measure: Phase I Stroke Pattern Characteristic Descriptions
timeFrame: Analysis results within 6 months.
measure: Phase II Reliability of IASTM Force Application
timeFrame: 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
measure: Phase III Reliability of Dynamic Pressure Pain Threshold Assessment
timeFrame: Measured within 2 hours on same day of testing. Results reported by end of study at one year.
Secondary outcomes:
measure: (Phase III Only) Heart Rate
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Blood Pressure
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Range of Motion
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Hamstring Length Flexibility Test.
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Trunk Forward Bend Flexibility Test.
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Strength
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Static Pressure Pain Threshold
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Skin Surface Temperature
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) 10-Meter Walk Test (10-MWT)
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
measure: (Phase III Only) Vertical Jump Test
timeFrame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Mary T Loghmani, PhD
role: PRINCIPAL_INVESTIGATOR
References: