Reduction of Pain and Fatigue after Use of Over-The- Counter Socks Embedded With Haptic Vibrotactile Trigger Technology: Results from the Invigor Study
Authors: Gudin Jeffrey , Fason Janet , Hurwitz Peter 
Published: April 2024

Introduction: The prevalence of pain, pain-related diseases, and fatigue related issues are so vast that they are the leading reasons patients visit their primary care provider. Over 100 million people are estimated to live with chronic or recurrent pain and fatigue is estimated to affect more than 50% of the population of older adults. Conventional pharmacological treatments targeting the symptoms of pain and fatigue have been associated with dangerous adverse effects. Clinicians are continuously trying to identify effective, alternative treatment strategies to address pain and fatigue, especially those that are non-invasive and non-pharmacologic with limited side effect profiles. It is proposed that humans have a widely distributed and perhaps unique neural network or “neuromatrix” that contributes to the multidimensional experience of pain. This neuromatrix is genetically determined and influenced by multiple factors, of which sensory (nociceptive) input is only one. Researchers have shown that these pathways and areas of the brain that are associated with the neuromatrix can change in response to external stimuli. Understanding this complex pain neuromatrix may assist in identifying alternative approaches that reduce pain severity and interference and improve patient outcomes. There are various types of nerve fibers responsible for sensation and pain. A-β nerve fibers transmit information from Pacinian and Meissner corpuscles, which convey vibratory/sensory perception from the skin. According to the gate control theory of pain hypothesized decades ago by Melzack and Wall, vibration can stimulate inhibitory interneurons in the spinal cord that in turn act to reduce the amount of pain signal transmitted by A-δ and C transmitting pain fibers. The application of vibration has long been trialed for its analgesic effects. When you get a text or a call on your mobile phone, the vibration you feel is a form of haptic feedback. An enhanced technique known as haptic vibrotactile trigger technology (VTT) is designed to target the nociceptive pathways and theorized to disrupt the neuromatrix of pain. The technology is non-pharmacological and non-invasive, and has been incorporated into topical patches, wearable clothing, and other routes of delivery. The purpose of this IRB-approved, minimal risk observational study was to evaluate and compare patients’ experiences, perceptions and response for those who received haptic vibrotactile trigger technology (VTT) embedded non-pharmacologic, non-invasive, overthe-counter wearable device in the form of socks (Superneuro Haptic Vibrotactile Trigger Technology (VTT) Enhanced Socks; Srysty Holding Co, Toronto, Canada) versus those who did not. Methods: Baseline, 7- and 14-day data were recorded in 90 subjects who presented with pain and/or fatigue related issues or associated symptoms. The ‘active’ treatment group (TG) was comprised of eighty-five (85) adult subjects (61 females and 24 males) with a mean age of 54.8 years; there were five (5) adult subjects (3 females and 2 males) in the ‘inactive’ control group (CG). The study evaluated changes in overall pain severity, pain interference, and fatigue severity via validated scales including the BPI (Brief Pain Inventory) and the BFI (Brief Fatigue Inventory) as well as changes in the use of prescription and OTC medications, patient satisfaction, energy levels, and any side effects reported while using the VTT Enhanced socks. Future analysis will compare the outcomes reported here with a larger control as well as the addition of a crossover treatment group.