ResearchArticle
AProspectiveSix-MonthStudyofChronicPainSufferers:ANovel
OTC Neuromodulation Therapy
Richard Staelin,
1
Sree N. Koneru,
2
and Ian M. Rawe
2
1
Duke University, Durham, NC, USA
2
BioElectronics 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
Guest Editor: Hai-Qiang Wang
Copyright©2019RichardStaelinetal.isisanopenaccessarticledistributedundertheCreativeCommonsAttributionLicense,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective. To assess the durability of treatment over various chronic pain conditions of an emerging, nonprescription elec-
tromagnetic 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.
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. 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.Sevendaysafterinitialtreatment,theaveragepainwasreducedto2.9,a65%painreductionforthe
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. ere 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.
1. Introduction
Developing long-term effective treatments for chronic pain
sufferers has proved to be elusive. Evidence from clinical
trials and systematic reviews indicate that many in-
terventions for chronic pain provide only mild-to-moderate
short-term benefits, with a lack of evidence for long-term
effectiveness [1]. e challenge with treating chronic pain is
reflected in the lack of correlation between pain level and
severity of tissue damage [2] due to complex changes in
immuno, sensory, hormonal, and inflammatory processes in
the peripheral and central nervous system. Repetitive no-
ciceptive stimulation induces pathophysiological changes in
the pain pathways leading to a persistent state of high re-
activity and a lowering of the pain threshold. Such a con-
dition is referred to as central sensitization (CS) [3, 4]. Often
this occurs after the onset of persistent acute pain which then
transitions to chronic pain and is marked by CS-associated
neuroplasticity. CS has been linked to the etiologies of os-
teoarthritis [2, 5], chronic lower back pain [6], plantar
fasciitis [7], fibromyalgia [8, 9], neuropathy [10], migraine
[11], and many other chronic conditions [6, 12, 13].
Recent guidelines on treating chronic pain recommend a
multimodal treatment approach, with an emphasis on
nonpharmacologic therapies prior to using pharmacological
treatments [14]. Bioelectronic medicine is one such treat-
ment approach aimed at providing therapeutic benefits and
involves the use of electrical, magnetic, optical, and ultra-
sound pulses to modulate nervous system activity (neuro-
modulation) [15]. ose devices that use electrical impulses
to achieve targeted neuromodulation are referred to as
“Electroceuticals.” ey do this through at least three
methods: invasive (implanted), semi-invasive (surface
electrodes, such as in transcutaneous electrical nerve
Hindawi
Pain Research and Management
Volume 2019, Article ID 3154194, 11 pages
https://doi.org/10.1155/2019/3154194