Over-the-counter Medical Device Offers Promise for Long Term Chronic Pain Relief

Ian Rawe Ph.D
BioElectronic Corporation
Frederick, MD

http://www.bielcorp.com/products/actipatch/
ActiPatch

PainRelief.com:  What is the background for this study?

Response: The aim of this study was to investigate the long-term effectiveness of a neuromodulation medical device (ActiPatch®) in relieving chronic pain. The device is topically applied, paresthesia-free and uses high-frequency electromagnetic fields to mitigate nerve sensitization and provide pain relief. Identified as Pulsed Short Wave Therapy (PSWT), this technology is available over-the counter in many countries, including the US, Canada, EU and Australia.

While existing randomized, placebo controlled clinical trials demonstrated PSWT treatment effectiveness over several weeks, data on long-term effectiveness was unavailable. In this study, a sample of 240 chronic pain subjects, who reported clinically significant pain relief (reduction ≥ 2 VAS points) following a 7-day trial of the medical device, agreed to participate in a six-month study to investigate treatment durability. These subjects indicated an average chronic pain duration of 6.5 years, in multiple locations and from a wide spectrum of causes (etiologies). Moreover, these subjects reported that their existing pain management regimen (often multimodal therapy) provided inadequate relief, and that they experienced severe to moderate pain (≥ VAS of 8/10), daily.

PainRelief.com: What are the main findings?

Response: Over the first 7-days of using the device, the average pain (change in VAS) in the sample was reduced by 65%. Over the six-month study period, the level of initial pain reduction was largely maintained – 58% reported now being only in mild pain, 36% reported moderate pain and only 6% reported remaining in severe pain. Additionally, the vast majority of subjects were able to reduce oral analgesic consumption, with 28% reporting elimination of oral analgesics by the end of the study. Taken together, the sustained pain relief and reduction in pain medication use resulted in subjects reporting substantial improvement in quality of life – the goal of medical interventions. A subject’s pain level at the end of the first 7-days was the only major predictor of their pain level at the end of six months (in terms of pain level, change in sleep, physical activity, quality of life and medication use).

PainRelief.com: What should readers take away from your report?

Response: Chronic pain sufferers who are dissatisfied with their existing pain management regimen may find this device to be a viable alternative. Importantly, sufferers can expect to know relatively quickly whether this device can be a long-term option – if they get significant pain reduction in the first 7 days of device use, then both patients and doctors can be quite confident that treatment effects (pain reduction, quality of life, etc.) will be maintained with continued treatment. This is very encouraging since many pain therapies can lose effectiveness with time. It also implies that for a low monetary cost (about $10) it is possible to determine if this mode of treatment will have long term efficacy for the chronic pain sufferer.

PainRelief.com: What recommendations do you have for future research as a result of this work?

Response: More clinical research is needed to better understand treatment effectiveness on different pain locations/etiologies, as well validating current findings of treatment durability. Additionally, basic science research will help elucidate the mechanism of action for this medical device, which is currently understood to be neuromodulation of peripheral nerves. In addition a comprehensive health economics study should be conducted to demonstrate that this device is not only effective in improving quality of life, but is also a cost effective treatment option. A small health economics study indicated that healthcare cost savings could be significant, and in fact this study resulted in the device being listed on the UK’s National Health Service (NHS) Title IX drug tariff, making it available by prescription for patients as well as over the counter.

PainRelief.com: Is there anything else you would like to add?

Response: The non-invasive, non-pharmacological nature of the device makes it a safer option than drug treatment for chronic pain sufferers, thus allowing a large segment of the population to use it. Also, the device is well suited for inclusion as an adjunct into existing pain management approaches – so subjects are not required to stop taking existing pain medication(s). This gives patients and doctors a non-pharmacologic option to manage chronic pain as part of a multimodal therapy.

Any disclosures?

Ian Rawe Ph.D is a paid employee of BioElectronics Corporation – the maker of the device used in the study.

Citation:

Richard Staelin, Sree N. Koneru, and Ian M. Rawe, “A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy,” Pain Research and Management, vol. 2019, Article ID 3154194, 11 pages, 2019. https://doi.org/10.1155/2019/3154194.

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