The Treatment of Rheumatoid Arthritis of the Hand with Pulsed Electrical Fields
The safety and effectiveness of stimulation from pulsed electrical fields using the Bionicare® Stimulator System Model BIO-1000TM was investigated for the treatment of rheumatoid arthritis (RA) of the hand. Eighty-nine patients were enrolled in a multi-center, double-blind, placebo device controlled clinical study. All patients met the inclusion and exclusion criteria of the American College of Rheumatology (ACR) for rheumatoid arthritis1 and had active symptomatic synovitis. Background arthritis medications were maintained constant throughout the study. Device was used for 8±2 hours daily for a four week treatment period. The weekly efficacy assessments included the physician’s global evaluation of the treated hand, the patient’s assessments of pain/symptoms and function, joint tenderness and swelling, range of motion, grip strength, morning stiffness and activities of daily living. The active device group demonstrated significant improvement compared to the placebo device group using repeated measures models for the physician’s global evaluation, the patient’s evaluation of pain/symptoms and the patient’s evaluation of function, all of the treated hand. There were no consistently significant trends for the other outcome measures. Transient skin rash, the only type of adverse event reported, was comparable between groups. This study suggests the Bionicare stimulator is safe and effective for treating rheumatoid arthritis of the hand.
KeywordsPlacebo Toxicity Arthritis Covariance Corticosteroid
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