Bionicare Medical Technologies, Inc, has announced results of a clinical trial at the American College of Rheumatology meeting. According to the company, “the BioniCare Hand Device is the first and only non-drug, non-invasive option cleared by the FDA in the U.S. for relieving hand pain associated with rheumatoid arthritis (RA).” The Bionicare system delivers pulsed electrical stimulation (PES) to the hand via a conductive glove and a second glove on the arm. What waveform do they pulse with? We’ll never know, it seems, it’s proprietary.
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.
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.
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