Massage Clinical Trial
Official title:
The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation
Verified date | November 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | October 19, 2022 |
Est. primary completion date | October 19, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Analysis results within 6 months. | |
Primary | 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 within 2 hours for same day reliability and at 7 days for between day reliability. Results reported by end of study at one year | |
Primary | 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 within 2 hours on same day of testing. Results reported by end of study at one year. | |
Secondary | (Phase III Only) Heart Rate | Radial pulse will be palpated to determine heart rate (in beats per minute, BPM). | Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (Phase III Only) Blood Pressure | Will determine systolic and diastolic blood pressure (in mmHg) using a stethoscope and sphygmomanometer. | Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (Phase III Only) Range of Motion | Will measure the amount (range) of trunk movement (in degrees) using a modified protractor. | Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. | |
Secondary | (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 before and within 2 hours after IASTM force application. Results reported by end of study at one year. |
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