Clinical data utilizing the DRX9000 True Non-Surgical Spinal Decompression System™ will be presented at the PainWeek Conference in Las Vegas, September 4-6, 2008. The first, is an IRB-approved, prospective multi-center phase II, non-randomized pilot study authored by Dr. John Leslie of the Mayo Clinic and others. This study was designed to evaluate the effectiveness and safety of the DRX9000 in treating chronic lower back pain. A greater than 50% reduction in pain score was observed after two weeks of treatment, and upon completion of the entire six week protocol an amazing success rate of 88.9% was documented. Improvement of Oswestry scores and a decreased consumption of adjunctive pain medication was also noted. The second, is retrospective data which included lumbar spine CT scans before and after patients were treated on the DRX9000 that demonstrates possible morphological changes associated with treatment. Dr. Christian Apfel, MD, Associate Professor of Anesthesiology and Perioperative Care at the University of California at San Francisco, will present this data at the PainWeek Conference. Dr. Apfel, lead author and his colleagues conclude, “A significant reduction in chronic LBP [lower back pain] after non-invasive spinal decompression correlated with an increase in disc height.” Abstracts of both studies will be available during the 2008 PainWeek Conference.
Non-treatment or control groups were not included making efficacy outcome versus placebo or spontaneous recovery difficult to determine. Randomized double-blinded or comparative long-term outcome trials are needed to further prove the efficacy of non-surgical spinal decompression systems such as the DRX9000™ for the routine treatment of chronic LBP. This study was partially funded by Axiom Worldwide.
A randomized controlled trial is needed to prove that restoration in disc height is the mechanism through which non-surgical spinal decompression systems such as the DRX9000™ leads to these impressive reductions in pain.
Axiom Worldwide manufactures and distributes its flagship products, the DRX9000 True Non-Surgical Spinal Decompression System™, DRX9000C™, and DRX9500™ in medical markets around the globe. Axiom also manufactures a digital electroceutical device, the EPS8000™, for use in relieving pain and for use in muscular rehabilitation. Axiom prides itself on providing safe, non-surgical alternatives that patients should consider prior to undergoing surgery.
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