The investigator-sponsored clinical study, funded by the University of California San Diego Department of Anaesthesiology, obtained three major measurements for both phantom pain and residual pain along with a change in both phantom and residual pain
BioElectronics’ Model 088 device delivers a pulsed shortwave therapy. (Credit: Towfiqu barbhuiya on Unsplash)
US-based medical technology products developer BioElectronics has announced the publication of a study using its pulsed shortwave therapy device to treat phantom and residual limb pain.
The study is titled “Treating intractable postamputation pain with wearable, non-invasive, non-thermal, pulsed shortwave therapy: a randomized, double-masked, sham-controlled, crossover pilot study”.
It was an investigator-sponsored clinical study, funded by the University of California San Diego Department of Anaesthesiology.
In the study, patients initially wore BioElectronics’ Model 088 device, with about half of the patients wearing the sham device, on the residual part of the limb for 28 days.
After 28 days, the patients started wearing the opposite device (the sham group) wore the active device, and the treatment group wore the sham device, for the next 28 days.
The study obtained three major measurements for both phantom pain and residual pain along with a change in both phantom and residual pain before, during, and after each 28 days.
The researchers presented the findings in a series of graphs over time depending on whether the patient was wearing the sham or active device.
Patients wearing sham device reported no change in the median phantom limb pain or pain in the residual limb, and no median change in their global assessment of pain.
In contrast, patients wearing active device reported a 40% to 50% decrease in the median measures for both average and worst residual and phantom limb pain by the seventh day, which continued through day 28.
Most patients wearing the active device reported the highest level of change in residual pain by day 21, and this continued through day 28.
The researchers conclude that the study identified beneficial treatment effects associated with using BioElectronics’ Model 088 in the setting of a low-cost and low-risk intervention.
Based on the results, the medical device maker aims to pursue qualified distribution partners to market and sell its unique pulsed shortwave device.