Trials of ActiPatch® Use For Osteoarthritis in Knees, Pain Control in Hernia Surgery and Lower Back Pain Relief Are Underway
FREDERICK, MD. June 24, 2013 — BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, today announced that three clinical trials at leading medical centers around the world have ethics approval and are now recruiting patients: the University George C Martin Rheumatology Department in Messina, Italy; Ghent University Hospital in Ghent, Belgium: and the Centre for Health Activity and Rehabilitation Research at the University of Otago in Dunedin, New Zealand.
“We expect these clinical trials to conclusively demonstrate the efficacy of ActiPatch® Therapy in treating pain and reducing the level of analgesic medication use in these common conditions,” said Ian Rawe, Ph.D., Director, Clinical Research at BioElectronics. “The trial in Italy is focused on osteoarthritis knee pain, the Belgium trial will measure its impact on inguinal hernia repair, while the New Zealand program is focused on treating acute lower back pain in the context of a comprehensive physical therapy program.”
“ActiPatch meets a compelling need for a safe, drug-free alternative to opioids and NSAIDs for treating pain,” Dr. Rawe said. “I expect these trials to demonstrate the efficacy and versatility of ActiPatch® for treating a variety of pain problems.” “It is important to note is that ActiPatchÒ was pilot tested, for all three of these clinical trials, with each investigator reporting promising results, this led all the lead investigators to move onto full randomized, double blind, placebo controlled clinical trials without significant financial support.”
The aim of the osteoarthritis knee study at the University George C Martin, Rheumatology Department, Messina is to evaluate the efficacy of ActiPatch on pain intensity reduction in patients affected by osteoarthritis as measured by Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The secondary aim is to evaluate the effect on knee effusion reduction (swelling), when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry (the minimal amount of pressure that produces pain). Knee swelling will be measured by ultrasound.
The study in New Zealand is evaluating the use of ActiPatch in the treatment of acute lower back pain as an adjunct to normal physiotherapy care. The principal investigator is using the Oswestry Disability Index to measure improvements and the statistical package for social sciences software (SPSS) for analysis.
The trial at Ghent University Hospital in Belgium will be treating inguinal hernias post surgical repair and evaluating the efficacy of RecoveryRx. The primary end point will be postoperative pain and analgesic medication use, with a secondary end point of chronic pain at 3 months post surgery, as the incidence of chronic pain is high with hernia repair. Pain levels and quality of life will be measured using VAS and EuraHS-Quality Of Life questionnaires.
A complete list of all ongoing clinical trial is available on our website at http://www.bielcorp.com/clinical-evidence/. For more information on the new trials:
- Ghent Hernia trial (ClinicalTrials.gov identifier: NCT01842204). http://www.clinicaltrials.gov/ct2/show/NCT01842204?term=pulsed+electromagnetic+fields&rank=19
- Messina osteoarthritis knee pain trial (ClinicalTrials.gov identifier: NCT01877278) visit http://www.clinicaltrials.gov/ct2/show/NCT01877278?term=pulsed+electromagnetic+fields&rank=4
- University of Otago lower back pain trial (trial ID: ACTRN12613000328774) visit the Australian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363892.
Note: all three studies are now recruiting patients which have not been updated in the clinical trial registry for two of the studies.
About BioElectronics Corporation
BioElectronics Corporation is the maker of an industry leading family of inexpensive, disposable, drug-free, anti-inflammatory devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx™ Devices for chronic and post-operative wound care; HealFast® Therapy (www.healfasttherapy.com) and the Allay™ Menstrual Pain Therapy. More info: www.bielcorp.com.