The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation

Indiana University106 enrolled

Overview

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.

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

106

Conditions

Massage

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

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.

Time frame: 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).

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

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.

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