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Clinical Research
VAX-D® therapy addresses the biomechanical aspects of discogenic disease and achieves its objective through decompression. It should be utilized in patients with low back pain, with or without radiculopathy who have failed conventional therapy (physiotherapy and chiropractic), and should be utilized prior to addressing surgery. By addressing the altered biomechanics responsible for disc disease, the VAX-D® therapeutic table not only alleviates pain but has been shown to exert a beneficial effect on a major determinant in the equation responsible for discogenic disease, that is elevated intradiscal pressure.
Further analysis of future and unpublished research should be considered to further validate the therapeutic benefit of VAX-D® therapy, however, these clinical studies have shown it to be effective in back pain syndromes with or without radiculopathy including herniated discs and internal disc disruption. The chronic back pain patients and surgical patients are very costly to society. Since many of these patients are responsive to VAX-D® therapy, this unique non-obtrusive means of managing the common forms of debilitating low back pain associated with discogenic disease could represent a considerable savings. VAX-D® OUTCOME STUDY Following two seperate FDA approvals (one for the device and one for the safety and efficacy of the treatment/decompression), 22 medical centers were asked to collect data on all patients who received VAX-D® therapy for low back pain. The purpose of the study was to assess the efficacy of Vertebral Axial Decompression Therapy in the treatment of low back pain resulting from documented lumbar disc disease. The patients ranged in age from 25 to 60 years at the treatment onset and they were followed from one to two years. All patients had failed proir attempts at treatment which included physical therapy, acupuncture, chiropractic care, epidural injections, and in some cases, surgical intervention. All patients had documented chronic back pain and pathology was found on MRI or radigraphic images. Use of a "double blind" type study was not practical as patients very early in the study would guess whether they were part of the "sham" group receiving only regular traction or part of the VAX-D® therapy group. An earlier study in Canada designed to be"double blind" soon found that patients refused regular traction as they discerned or discovered that they "were not getting the better treatment". The study was divided into five diagnostic groups which were comprised of patients with extruded herniated discs; multiple herniated discs without extrusion, with or without degenerative disc disease; single herniated disc, regardless of degenerative disease; degenerative disc disease. without herniation; and facet syndrome. Each patient chose a subjective pain index ranging from 0 to 5 (5 being severe pain) and a disability index of 0 to 3 (3 being bedfast). Each was also assessed for objective signs of decreased mobility on a 0 to 3 scale (3 being completely immobile). They were assigned by diagnosis into one of the above five groups. All patients received VAX-D® Therapy of at least 10 sessions plus additional treatments if the patient continued to improve. Patient history, schedule, including frequency and intensity of therapy, was recorded along with patient symptoms and satisfaction with treatment. Measurements were made at the beginning, mid-point, and end of treatment. If treatment success is defined as a reduction in pain to 0 or 1 on a 0 to 5 scale, the treatment was successful in 75% of the patients. The success rate varied from 67% for the patients with extruded herniated discs, to 77% for patients with degenerative disc disease or single herniated discs. It was 71% for people with multiple herniated discs and 70% for facet syndrome. On a pain scale of 0 (none) to 5 (severe), the people with extruded herniated discs had an average pain of 4.19 at the beginning of treatment and an average of 1.33 after treatment, a reduction of 68%. The cases of multiple herniated discs went from 4.15 to 1.17, a reduction of 72%. The patients with a single herniation had a reduction from 4.14 to 1.08, or 74%. The degenerative disc cases went from 3.94 to 1.03, a 74% reduction. Those with facet syndrome went from 4.10 to 0.97, a 76% reduction in pain. In summary, the data on mobility and ADL appear to correspond to pain results and it appears that approximately 20 treatments with VAX-D® Therapy has been proven to be effective in about three-fourths of all patients who have any combination of these types of disc disease. |
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