BioElectronics Begins Back Pain Clinical Study

BioElectronics Corporation has begun a clinical study investigating the efficacy of ActiPatch in treating chronic lower back pain. The objectives of this additional back pain study are to support Mundipharma’s Australia and New Zealand sales and marketing, provide local economic data for product reimbursement, and to document ActiPatch’s effectiveness on central sensitization pain.
 
Chronic low back pain is very challenging to treat given its association with “central sensitization,” as sufferers experience exaggerated pain perception² and are often resistant to standard treatments. Sree Koneru, Ph.D., vice president of Product Development at BioElectronics, said, “There is already real-world and clinical evidence that ActiPatch is effective in reducing back pain.³ More than 30 million Americans are affected by chronic low back pain, collectively spending more than $90 billion annually in treatment costs.”¹
 
The study will involve 142 subjects who have been suffering with low back pain for more than three months at the time of enrollment; the trial is scheduled to take place over a 30-day period and involve two visits. During the first visit, baseline data about the subject, including pain intensity, functionality and sleep quality will be collected. They will then receive, randomly, either an active or sham ActiPatch device along with instructions on how to use it for the next 30 days. During the final follow up visit, additional data will be collected to evaluate improvements in pain and other outcome measures. 
 
The study is being conducted by the Pain Management Center of the prestigious Royal Prince Alfred Hospital in Sydney, Australia. The principal investigator (PI) leading the study is Graeme Campbell, a physiotherapist, supported by his team of physicians and clinical researchers.

BioElectronics Corporation develops non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx Devices for chronic and post-operative wound care; Allay Menstrual Pain Therapy. 
 
References
¹ M. A. Davis, “Where the United States Spends Its Spine Dollars: Expenditures on different ambulatory services for the management of back and neck conditions,” Spine, pp. 1693-1701, 2013.
² S. et.al., “Central sensitization in chronic low back pain: A narrative review.,” J. Back Muscloskeletal Rehabil., pp. 625-633, 2016.
³ R. Staelin, S. Koneru and I. Rawe, “Chronic Back Pain Therapy Using the ActiPatch: A Registry of Pain Relief, Medical Use and its Side Effects,” Pain Management , vol. 7, no. 2, pp. 99-111, 2017.