Rational approach, technique and selection criteria for the treatment of lumbar disc herniation with Regenerative Selective Disc therapy

Low back pain is one of the most common and important clinical, social, economic, and public health problems affecting the human population worldwide. The mechanism of radicular pain in the lumbar region is multifactorial but is likely due to mechanical and/or inflammatory factors. The natural history of disc herniation tends to be favourable. The Italian Society for Oxygen-Ozone Therapy (SIOOT) and the Italian Society for Spinal Surgery (SICV) guidelines recommend a conservative therapeutic approach. The biological action of medical ozone is still under investigation but some mechanisms of action have been proposed to explain its efficacy in disc herniation treatment: i) reduction of the inflammatory components; ii) hyper-oxygenation of the area of interest; iii) diminishing the size of the herniation; iv) stimulation of the repair process. The primary objective of this pilot study was to compare pain and function scores from patients before and after the treatment with Regenerative Selective Disc. The metrics that were established to define significant improvement were: i) improvement >1.8 on the Visual Analogue Scale (VAS) score; ii) improvement of 1 level or more on the modified Macnab criteria; iii) improvement >15% on the Oswestry Disability Index (ODI). Primary endpoints of this study were changes in the pretreatment and 1 month post treatment VAS, ODI and Macnab scores of the patients. After treatment results show that the patient population’s mean VAS, ODI and modified Macnab scores improved beyond the significant improvement scores. In fact, results showed that the mean patient’s population improvement scores were 2.9 for VAS, 22 for ODI and 1.4 for modified Macnab. Additionally, significant improvements were shown for 87% of the patients for VAS scale (>2.0), 80% of the patients for the ODI scale (>15 points) and 80% patients for the modified Macnab criteria (>1 point).