BIEL Research Paper published today
A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy
Richard Staelin,1 Sree N. Koneru,2 and Ian M. Rawe,2
1Duke University, Durham, NC, USA
2BioElectronics Corporation, Frederick, MD, USA
Correspondence should be addressed to Ian M. Rawe; ian.rawe@gmail.com
Received 25 June 2019; Accepted 7 September 2019; Published 30 September 2019
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.
5. Conclusion
Electroceuticals offer immense potential as a nonpharmacological intervention for chronic pain management. Current over-the-counter electroceuticals, such as TENS devices, rely on skin contact to achieve neuromodulation. However, continuous/recurring use of TENS is limited due to the potential for skin damage, need for short use duration (typically, less than 30 mins, twice a day), and unpleasant sensations (shocks, tingling). PSWT electroceuticals, on the other hand, use electromagnetic fields (EMF), which easily pass through skin/bandaging, can be incorporated into wraps/braces and are well tolerated by patients owing to a lack of any sensation during use. This prospective study involved a 6-month assessment of 240 chronic pain subjects, who at the time of enrollment had obtained pain relief after 7 days of treatment with a commercially available PSWT electroceutical device. The results indicate that pain relief was sustained for 6 months in over 85% of subjects. In addition, subjects reported a substantial improvement in functionality through measures such as physical activity, sleep quality, and overall quality of life. They also decreased consumption of pain medication, including prescription and opioid-based pain medications.
A major objective of any electroceutical is to serve as an effective adjunct for multimodal pain management. PSWT was found to be consistently effective in providing pain relief for varying pain etiologies and in multiple anatomical locations. Given the lack of adverse effects and ability of patients to tolerate long-term PSWT use, it is the authors’ conclusion that PSWT is an effective, over-the-counter electroceutical therapy for a substantial portion of the chronic pain population.
https://www.hindawi.com/journals/prm/2019/3154194/
A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy
Richard Staelin,1 Sree N. Koneru,2 and Ian M. Rawe,2
1Duke University, Durham, NC, USA
2BioElectronics Corporation, Frederick, MD, USA
Correspondence should be addressed to Ian M. Rawe; ian.rawe@gmail.com
Received 25 June 2019; Accepted 7 September 2019; Published 30 September 2019
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.
5. Conclusion
Electroceuticals offer immense potential as a nonpharmacological intervention for chronic pain management. Current over-the-counter electroceuticals, such as TENS devices, rely on skin contact to achieve neuromodulation. However, continuous/recurring use of TENS is limited due to the potential for skin damage, need for short use duration (typically, less than 30 mins, twice a day), and unpleasant sensations (shocks, tingling). PSWT electroceuticals, on the other hand, use electromagnetic fields (EMF), which easily pass through skin/bandaging, can be incorporated into wraps/braces and are well tolerated by patients owing to a lack of any sensation during use. This prospective study involved a 6-month assessment of 240 chronic pain subjects, who at the time of enrollment had obtained pain relief after 7 days of treatment with a commercially available PSWT electroceutical device. The results indicate that pain relief was sustained for 6 months in over 85% of subjects. In addition, subjects reported a substantial improvement in functionality through measures such as physical activity, sleep quality, and overall quality of life. They also decreased consumption of pain medication, including prescription and opioid-based pain medications.
A major objective of any electroceutical is to serve as an effective adjunct for multimodal pain management. PSWT was found to be consistently effective in providing pain relief for varying pain etiologies and in multiple anatomical locations. Given the lack of adverse effects and ability of patients to tolerate long-term PSWT use, it is the authors’ conclusion that PSWT is an effective, over-the-counter electroceutical therapy for a substantial portion of the chronic pain population.
https://www.hindawi.com/journals/prm/2019/3154194/
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