An observational study in Massage, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-14.
Sponsored by Indiana University · 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:
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.
Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy, males and females, ages 18-75.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase I
Phase II
Phase III
Exclusion Criteria:
Phase I
Phase II
Phase III 1. The same exclusion criteria as for Phase II.
-
Fifteen (n=15) experienced clinicians, each with 8 or more years experiences in instrument-assisted soft tissue manipulation (IASTM), will participate in an observational studying analyzing their application of basic stroke patterns (linear, curved) to a consistent research assistant/model. IASTM is a type of massage that uses rigid devices. A Quantifiable Soft Tissue Manipulation (QSTM) device system will be used for determining objective metrics of stroke parameters (e.g. stroke force, rate, angle) and results will be compared between participants to determine characteristic stroke profile patterns for use in training and research.
The reproducibility of applying a targeted STM stroke force will be determined within and between therapists, both with and without visual monitoring of the QSTM metrics and graphic display. Two novice and two experienced therapists will be trained using QSTM. A novice is defined as a clinician with \<1 year and an experienced with \>8 years of practice. Fifty (n=50) healthy, non-obese subjects will be enrolled that meet the inclusion/exclusion criteria. First, the clinicians will apply a self-perceived "moderate" force for 15sec (non-therapeutic dose), within subject tolerance, without using QSTM feedback. Then, the clinician will apply a targeted force of 10N with visual monitoring of QSTM feedback. This process will be repeated 5-7 days later to determine repeatability. After testing, subjects will participate in simple back and/or leg stretches and an ice pack applied.
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.
Device: Quantifiable Soft Tissue Manipulation (QSTM)
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.
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.
(Phase III Only) Heart Rate
Radial pulse will be palpated to determine heart rate (in beats per minute, BPM).
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Blood Pressure
Will determine systolic and diastolic blood pressure (in mmHg) using a stethoscope and sphygmomanometer.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Range of Motion
Will measure the amount (range) of trunk movement (in degrees) using a modified protractor.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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).
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(Phase III Only) Strength
A handheld dynamometer will be used to test the strength (Newtons of force) of the subject's back and thigh.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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.
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
(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
Time frame: Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.
Plan to share: Yes — Upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After July 31, 2022 for one year
Access criteria: Other research institution PI or as requested upon review.
Ran from May 2021 to primary completion in Oct 2022, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.