Kalaco Scientific, Inc.

Results of a randomized, double-blind pilot study indicate that transcranial electrotherapy stimulation may be an effective treatment for the temporary reduction of pain in osteoarthritis patients. Presently, the predominant method for pain management is medication. One very different approach is the application of micro- to milliamp current applied to specific areas of the head, resulting in a release of endogenous opioids from pain management regions of the brain. For the pilot study, 64 subjects suffering from osteoarthritis of the knee and/or hip were enrolled. For two weeks prior, then during and after treatment, subject pain was self-assessed using the visual scale (VS). In addition, subjects were globally assessed by a physician. All subjects, device operators and physicians were blinded as to whether subjects were treated with an active or sham device. Data collected from the study indicate both a decrease in VS pain scores and a significant improvement (p = 0.05) in physician assessment in subjects treated with active devices compared to those treated with the sham device.