A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy.

Richard Staelin,Ian M Rawe,Sree N Koneru

doi:10.1155/2019/3154194

Richard Staelin, Ian M Rawe + Show 1 more

Open Access

https://doi.org/10.1155/2019/3154194

Copy DOI

Abstract

Objective To assess the durability of treatment over various chronic pain conditions of an emerging, nonprescription electromagnetic neuromodulation device that uses pulsed shortwave therapy. Methods A 6-month prospective study, involving 240 chronic pain sufferers, 94% of whom reported using pain pills and 98% reported using pain therapies prior to entering the study. Their average baseline pain was 8.2 VAS points before treatment; they had a pain duration of 6.5 years, and they were positive responders to pulsed shortwave therapy in an initial 7-day trial. Prospective assessments were obtained at intervals of 3, 4, and 6 months following a retrospective 7-day assessment. Longitudinal analyses were conducted to determine pain relief trends after the initial 7-day device use. Results Seven days after initial treatment, the average pain was reduced to 2.9, a 65% pain reduction for the study subjects. At the 6-month measurement, the average pain was 3.3, a 60% pain reduction from baseline. Only 17% of the subjects saw their pain level increase although this new level was still lower than baseline pain. Pain relief translated into improved quality of life and reduced medication use for the majority of the subjects. There were no significant adverse side effects reported over the 6 months of use. Conclusion Ninety-seven percent of the recruited subjects, all of whom had previously reported clinically significant pain relief using the 7-day PSWT device, sustained this relief for 6 months by using the device on an as-needed basis.

Highlights

Developing long-term effective treatments for chronic pain sufferers has proved to be elusive
When tracking the consistency of an individual’s pain relief over time, we found that 72% of subjects who report their pain after the 7-day treatment as mild will continue to experience this level of pain relief even at the end of the 6month period. e same pattern was observed for subjects reporting moderate pain after 7-day treatment, with 83% of these subjects reporting mild-moderate pain after 6 months
While the decrease in pain level and an increase in functionality/quality of life (QoL) over the 6-month period could be attributed to causes other than the medical device, it is to be noted that these subjects had experienced persistent pain for several years and tried multiple interventions—without obtaining substantial and/or sustained pain relief. us, there is little reason to expect that this pain relief fortuitously occurred in the study period

Summary

Objective

To assess the durability of treatment over various chronic pain conditions of an emerging, nonprescription electromagnetic neuromodulation device that uses pulsed shortwave therapy. Eir average baseline pain was 8.2 VAS points before treatment; they had a pain duration of 6.5 years, and they were positive responders to pulsed shortwave therapy in an initial 7-day trial. Longitudinal analyses were conducted to determine pain relief trends after the initial 7-day device use. Seven days after initial treatment, the average pain was reduced to 2.9, a 65% pain reduction for the study subjects. At the 6-month measurement, the average pain was 3.3, a 60% pain reduction from baseline. Ninety-seven percent of the recruited subjects, all of whom had previously reported clinically significant pain relief using the 7-day PSWT device, sustained this relief for 6 months by using the device on an asneeded basis

Introduction

Results

Conclusion

Conflicts of Interest