Poster Abstracts
Jeffrey Gudin, MD
Faculty, Practicing Physician
University of Miami
Englewood, New Jersey
Peter Hurwitz, NA
President
Clarity Science
NA, New Jersey
The prevalence of pain and pain-related diseases are so vast that they are the leading causes of disability and disease burden across the globe. Over 100 million people are estimated to live with chronic or recurrent pain in the United States and it is the most common reason patients consult primary care clinicians. Conventional pharmacological treatments for pain have been associated with dangerous adverse effects. Identifying effective, alternative treatment strategies, including those that are non-invasive and non-pharmacologic and that have reduced and limited side effect profiles, will provide options that may be preferable in how clinicians traditionally treat pain. Understanding the pain neuromatrix may assist in identifying these alternative approaches that reduce pain severity and interference, and that improve patient outcomes.
The neuromatrix of pain is a network of neuronal pathways and circuits responding to sensory (nociceptive) stimulation. Researchers have shown that these pathways and areas of the brain that are associated with the neuromatrix can change in response to external stimuli. Haptic vibrotactile trigger technology (VTT) is designed to target the nociceptive pathways and theorized to disrupt the neuromatrix of pain. The technology has been incorporated into non-invasive, non-pharmacological topical patches and other routes of delivery.
In recent years, several medical associations have updated their guidelines for pain management and recommend a multi-modal approach that includes non-invasive and non-pharmacological therapies as a first line treatment before consideration of other approaches. It is important to investigate novel nonpharmacologic treatment options for patients as part of a multi-modal treatment approach to maximize effectiveness, improve a patient’s quality of life (QoL), and restore function.
Purpose/Objectives:
The purpose of this IRB-approved, minimal risk observational study was to evaluate patients’ experiences and/or perceptions and patient response for those who received a haptic vibrotactile trigger technology (VTT) embedded non-pharmacologic, non-invasive, over-the-counter pain patch (FREEDOM Super Patch with VTT; Srysty Holding Co, Toronto, Canada).
Method:
Baseline, 7- and 14-day data were recorded in one hundred forty-eight (148) adult subjects (96 females and 52 males) with a mean age of 53 years who presented with mild, moderate and even severe musculoskeletal, arthritic and neurological pain. The study evaluated changes in overall severity and interference scores via a validated scale (Brief Pain Inventory (BPI)), changes in the use of prescription and OTC medications, patient satisfaction, and any side effects reported while using the patch. Future analyses will compare the outcomes reported here with non-active control and crossover treatment groups.
Results:
The results showed statistically significant decreases in mean BPI severity and interference scores after using the VTT embedded pain patch. After 14 days, the vast majority of patients reported “less” or “a lot less” usage of oral medications and were very/extremely satisfied with the patch. Results also showed statistically significant and positive outcomes in all measured Quality of Life (QoL) components with improvements in general activity, mood, relations with other people, sleep, normal work, walking ability, and enjoyment of life.
Conclusions: Study results indicate that this non-pharmacologic, non-invasive, haptic vibrotactile trigger technology (VTT) embedded topical patch reduces pain severity and interference scores and may reduce the use of concurrent medications, including prescribed anti-inflammatory and other oral medication for adult patients with arthritic, neuropathic, and musculoskeletal pain. Results reported suggest that the non-pharmacological topical pain patch has incredible potential to be added to the current arsenal of noninvasive and nonpharmacological pain therapies.
Disclosures
Jeffrey Gudin MD has received compensation from Clarity Science LLC for his role as principal investigator and for providing protocol-required services for the study. Peter L Hurwitz is President of Clarity Science LLC. Funding of the study was provided by Srysty Holding Co., Toronto, Canada. The authors report no other disclosures.
References: Finley CR, Chan DS, Garrison S, et al. What are the most common conditions in primary care? Systematic review. Can Fam Physician. 2018; 64: 832-840.
Cuomo A, Bimonte S, Forte CA, et al. Multimodal approaches and tailored therapies for pain management: the trolley analgesic model. J Pain Res. 2019; 12: 711-714.
Sharon L Kolasinski, Tuhina Neogi, Marc C Hochberg, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020; 72: 149-162.
Gudin JA, Dietze DT, Hurwitz PL. Improvement of Pain and Function After Use of a Topical Pain Relieving Patch: Results of the RELIEF Study. J Pain Res. 2020; 13: 1557-1568.
Gudin JA, Dietze DT, Hurwitz PL. Using Nanotechnology to Improve Pain and Function with a Novel, Drug-Free, Topical Pain-Relief Patch: An Interim Analysis. Anesth Pain Res. 2020; 4: 1-10.
Argoff CE. Topical analgesics in the management of acute and chronic pain. Mayo Clin Proc. 2013; 88: 195-205.