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.

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Background and Aims: Activation of ANCS of the brain using a quasy resonance frequency of 77.5 Hz was proven effective in clinical and experimental studies. The Nexalin design, uses a proprietary wave form based on 77.5 Hz. The result is Nexalin provides stimulation without sensation under electrodes (US Patent 6,904,322 B2). The aim is to determine the possibility of decreasing pain caused by osteoarthritis (OA) by using the Nexalin design. Methods: 200+ patients with OA of knee and/or hip joints comprised the groups. The study was randomized, double-blind. The NEXALIN groups received 7 daily treatments of 40 minutes, 15 mA (root mean square); the placebo group received no stimulation using a visually identical device. Assessment methods: pain level (PL), patient global self-assessment (PGA), walking test (WT), physician's assessment (PA) -all utilizing visual scales. Assessments were performed during three weeks prior, one week during, 2 week after the completion of treatment. Preliminary Results: After 7 treatments: PL decreased in the NEXALIN group 57%, placebo 24% (p < 10-9), WT 54% and 30% (P < 10-4); PGA and PA increased respectively 47% and 25% ((P < 0.04), 44% and 32% (P < 0.03). After 2 weeks: PL decreased in the NEXALIN group 40%, placebo 21% (p < 10-4), WT 42% and 30% (P < 0.01); PGA and PA increased respectively 29% and 25% (P < 0.66), 42% and 30% (P < 0.01). The number and type of side effects were equivalent in both groups, with quantities in placebo exceeding active. Conclusions: NEXALIN provides significant decrease of pain associated with OA and improvement in general condition.