Reducing Pain and Improving Mobility Using Haptic Patch Technology: Results of the RESTORE Study.

INTRODUCTION: Acute and chronic pain affects patients' overall health status and well-being, and the assessment and treatment of these patients can be challenging. Unfortunately, many patients fail to respond to the available multimodal treatment options, with some even failing advanced interventions including surgery. Therefore, alternative approaches to pain treatment represent an unmet medical need. Haptic vibrotactile trigger technology (VTT) is designed to target nociceptive pathways and is theorized to disrupt the neuromatrix of pain. The aim of this study was to evaluate the analgesic effects of a wearable VTT haptic patch in adults diagnosed with mild-to-moderate acute or chronic pain. METHODS: This was a prospective, randomized, controlled, double-blind study. A total of 118 research participants (58 male, 60 female) met the inclusion criteria and were enrolled in the study. Participants were randomly assigned to either a treatment group receiving the active patch (N = 64) or a control group which used a similar-appearing vehicle/placebo patch (N = 54). Assessments were performed at baseline (day 0), day 7, and day 14. Reduction in pain severity and interference was assessed using the validated Brief Pain Inventory (BPI), and range of motion/flexibility assessment was performed using the Schober (only for low back pain), goniometer, and bubble inclinometer tests. Data for the active patch user group and the control group were aggregated and compared over the 14-day time frame of the study. RESULTS: The active patch user group had significantly greater improvement in pain severity and reduction in pain interference; in addition, the active patch group showed greater objective improvement in range of motion (ROM)/flexibility than the control group at day 7 and day 14. CONCLUSION: These findings suggest that this non-pharmacological, noninvasive, topical VTT haptic patch (FREEDOM Super Patch with VTT) can reduce pain severity and increase ROM/flexibility. Considering the multitude of serious adverse effects associated with standard pharmacological pain treatments, clinicians should consider this readily available, over-the-counter VTT patch as a potential first-line or adjunct therapy to treat pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT06505005.