FREDERICK, MD–(Marketwired – Oct 16, 2017) – BioElectronics Corporation ( OTC PINK : BIEL ), www.bielcorp.com is pleased to announce the commencement of a clinical study investigating the efficacy of ActiPatch in treating chronic musculoskeletal lower back pain. Low back pain is highly prevalent and affects 1 in 3 adult Americans, accounting for about $ 90 billion in direct spending every year.
Chronic low back pain, along with other chronic musculoskeletal pain conditions like knee pain and plantar fasciitis, is now widely understood to be due to central sensitization, which leads to exaggerated pain perception . Ian Rawe, Ph.D., Director of Clinical Research at BioElectronics said “there is significant real world data that the ActiPatch is an effective therapy for chronic low back pain , so this randomized, double-blinded, sham-controlled study is being conducted to further strengthen our clinical evidence for treating low back pain with ActiPatch, and will complement the Oxford University Study currently being conducted.”
The study will involve 60 subjects who have been suffering with low-back pain for at least 3 months prior to the time of enrollment. The study is scheduled to take place over a 4-week period and involve to visits to a clinic. During the first visit, baseline data about the subject, including pain level and quality of life 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 4 weeks. During the final follow up visit, additional data will be collected to evaluate pain changes, among other measures like medication change. Full details about the study can be found at the NIH’s clinical trials listing page: (https://clinicaltrials.gov/ct2/show/NCT03240146)
The principal investigator (PI) leading the study is Dr. Chandrasekhar Koneru, M.D., an Alabama-based physician of internal medicine. Dr. Koneru has years of experience diagnosing and treating chronic low back, among other primary health conditions. “We are excited to test this technology in a scientific manner, especially in light of the ongoing opioid epidemic. I am optimistic that the study will help chronic back pain sufferers,” Dr. Koneru said.
Ian Rawe, Ph.D., Director of Clinical Research at BioElectronics is a co-PI and will assist in timely completion of the study. “Low back pain is a very large chronic pain category for which there are few effective treatments. A successful study will help in seeking a broader non-prescription indication for the treatment of musculoskeletal pain, from the FDA,” Dr. Rawe said.
About BioElectronics Corporation
BioElectronics Corporation is a leader in 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. For more information, please visit www.bielcorp.com.