Research Report on the Willow Curve
Background: Tiziano Marovino, DPT, MPH, DAIPM, is senior vice president of Health Strategy and Innovation at the Biogenesis Group, a disease management and senior human performance research center in Ypsilanti, Michigan, where he performs clinical research in health economics, measurement studies, and population health. He is an adjunct faculty member at the College of St. Scholastica in Duluth, Minnesota, where he has taught differential screening in the PT program, and is in the PhD Human Performance program at Concordia University. Dr. Marovino serves as PPM’s pain device expert.
Dr. Marovino became familiar with the Willow Curve though a patient who was experiencing improvement in their pain condition by using a Willow Curve at home. Dr. Marovino independently undertook the Willow Curve research project and submitted the results to Willow Labs, LLC.
Conclusion: Patients using the Willow Curve are over 2x more likely to reduce their pain by 3-10 pain scale numbers with a single treatment.
Research Brief: With all our devices under evaluation we first try and understand the device as much as possible, so we are following any procedural issues, i.e. to ensure we use it the way it was meant to be used. Once we understand the device and have developed experience using it, we begin to collect patient data from real patients who have the condition of interest. We use a combination of standardized outcome measures (patient reported outcomes-PRO) and biometric/performance measures depending on the dependent variable under study.
Our first step is we perform a proof of concept study that simply tells us whether the device demonstrates effectiveness: In the case of the Willow Curve (WC), does it reduce joint/muscle pain?
Specific to the WC we decided that a 3/10 decrease in pain for any given session is a meaningful outcome, so we have tracked the number of successful treatment sessions vs. the number of non-successful treatments and we turn these into probability statements or an Odds Ratio. This is simply defined as the probability of success (3/10 vas drop) over the probability of failure (2/10). In epidemiology we refer to this as an “effect size” since it provides useful data on how effective a therapy or intervention is at the patient level.
Our last analysis of WC indicated an Odds Ratio of 2.2, which means patients using the Willow Curve are over 2x more likely to reduce their pain by 3-10 pain scale numbers with a single treatment.
For our analysis we have used both a conventional OR, and a Modified Odds Ratio, where we use the same patient cohort acting as their own controls. We can analyze the data in any of a number of ways, but we have found that using the OR provides an intuitive approach to estimating an effect size that payers, providers and the public can understand and relate to, i.e. a probability statement.
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