SPARKS, Md., Nov. 16 /PRNewswire/ -- BioniCare Medical Technologies, Inc. announced results of a clinical trial today at the American College of Rheumatology (ACR) meeting in San Diego. The study of 89 patients with rheumatoid arthritis of the hand proved that pulsed electrical stimulation (PES) treatments, using a proprietary signal, are a significant non-toxic and non-invasive therapy option that relieves the pain and symptoms of RA, while also improving overall hand function.
New BioniCare Hand Device Offers Adjunctive Therapy for RA Patients
"Pulsed electrical stimulation with very specific signals improves the symptoms of RA of the hand," said Dr. Thomas Zizic, president, CEO and cofounder of BioniCare Medical Technologies, Inc. "Many patients with RA find relief in biologic therapies, DMARDs, prescription or over-the-counter (OTC) medications like NSAIDS and analgesics. However, even with all these medications, RA of the hand can be debilitating, deforming and immobilizing. Use of the new BioniCare RA Hand Device by study participants resulted in considerable improvement in mobility and joint stiffness, providing a promising adjunctive treatment for RA sufferers."
The double-blind placebo-controlled study was conducted over four weeks within six clinics and involved treatment under physician care. Patients and their physicians reported an improvement over baseline in RA pain and symptoms and hand function based on a VAS scale.
While all the study patients were fitted with the new BioniCare RA Hand Device -- a portable, battery operated generator that delivers electrical signals to the surface of the skin through a conductive fabric glove and a second electrode on the arm -- study investigators analyzed the data by dividing patients into two groups. One group received an active RA Hand Device that delivered a very specific, time-varying electrical signal in the joints of the more affected hand for 6 to 10 hours per day. The placebo group wore the device for the same amount of time and received two minutes of therapy at the beginning of each session prior to having the signal shut off.
Added Pain Relief With No Serious Side Effects
The study was designed to determine if a PES device applied externally to the hand could ameliorate the symptoms of RA hand. In addition to meeting ACR criteria for RA, patients also had to be undergoing stable DMARD therapy for four months prior to entering the study. Stable arthritis medication was maintained throughout the trial.
Statistically significant improvement occurred in physician's global evaluation, patient assessment of pain and symptoms and patient assessment of physical function. There were no reports of any systemic adverse events.
"This new data demonstrates that patients receiving PES therapy improved their symptoms of RA hand with very minimal side effects," notes Dr. Zizic. "Thus, based on the results of this analysis, it would be beneficial for physicians and patients to consider the BioniCare RA Hand Device as a complimentary, non-invasive treatment to current RA therapy options."
About Rheumatoid Arthritis
An estimated 3 million adults are affected by rheumatoid arthritis (RA), which can afflict any area of the body but is most evident in the hands and fingers. Rheumatoid arthritis affects the cells that line and normally lubricate the joints, known as synovial tissue. RA is a systemic condition, which means that it affects multiple joints, usually on both sides of the body. The joint lining becomes inflamed and swollen. The swollen tissue may stretch the surrounding ligaments -- connective tissues that hold bones together -- resulting in deformity and instability. Rheumatoid arthritis of the hand is most common in the wrist and finger knuckles (the metacarpophalangeal or MP joints).
For more information about the company and the benefits of BioniCare's non-invasive, non-drug option for treating RA of the hand, please visit http://www.bionicare.com.
About the BioniCare RA Hand Device
The BioniCare RA Hand Device works through low amplitude electrical stimulation and is a non-drug, non-invasive treatment option for RA of the hand. Its benefits include:
* Targeted, durable relief of pain and associated symptoms * Improved hand and joint function * Substantial improvement over baseline anti-inflammatory medications * Excellent safety profile * Ease of use About BioniCare Medical Technologies, Inc.
BioniCare Medical Technologies, Inc. develops and markets devices to meet the growing needs of more than 70 million Americans who suffer from the painful complications of arthritis and related musculoskeletal diseases. Through application of its patented technology, BioniCare is dedicated to the discovery of non-invasive devices for the regeneration of musculoskeletal soft tissues to significantly improve the quality of patients' lives.
BioniCare Medical Technologies, Inc.CONTACT: Jonathan Cabral, Executive VP Sales & Marketing of BioniCareMedical Technologies, Inc., +1-410-472-1888, jcabral@bionicare.com
Web site: http://www.bionicare.com/
