THE PROCEDURE: The vertebral axial decompression (VAX-D) system is a specialised table and computer designed to apply distractive tension along the axis of the spine. The VAX-D system allegedly decompresses herniated or degenerated intervertebral discs, and is claimed to alleviate pain and neurological deficits associated with nerve root compression. MEDICAL SERVICES ADVISORY COMMITTEE -- ROLE AND APPROACH: The Medical Services Advisory Committee (MSAC) is a key element of a measure taken by the Commonwealth to strengthen the role of evidence in health financing decisions in Australia. MSAC advises the Commonwealth Minister for Health and Aged Care on the evidence relating to the safety, effectiveness and cost-effectiveness of new and existing medical technologies and procedures, and under what circumstances public funding should be supported. A rigorous assessment of the available evidence is thus the basis of decision making when funding is sought under Medicare. A team from M-TAG Pty Ltd was engaged to conduct a systematic review of literature on the Vertebral Axial Decompression Table. A supporting committee with expertise in this area then evaluated the evidence and provided advice to MSAC. Assessment of the vertebral axial decompression table The evidence pertaining to the vertebral axial decompression (VAX-D) table has been assessed in three separate patient groups with chronic (> 3 months duration) low back pain that is refractory to conservative treatment: (1) patients with radiculopathy or radicular pain caused by a herniated intervertebral disc, (2) patients with radiculopathy or radicular pain caused by a degenerated intervertebral disc, and (3) patients with nonspecific low back pain. Each of the patient groups listed above has a different comparator, reflecting the differential treatment of patients with these distinct diagnoses. For patient group (1) the most appropriate comparator is discectomy or microdiscectomy. For patient group (2) the most appropriate comparator is laminectomy, with or without fusion, or laminotomy. And finally, for patient group (3) the most appropriate comparator is ongoing conservative treatment. One randomised, controlled clinical trial of VAX-D therapy has been conducted, and the patients recruited to this trial correspond to patient group (1) above. The remaining evidence relating to VAX-D therapy is from quasi-experimental non-randomised studies and case-series, and was obtained from mixed patient populations. There is insufficient follow-up of patients from any of the groups listed above. CLINICAL NEED: In Australia, low back pain is one of the most common causes of chronic disability, and one of the most common reasons for health-care resource utilisation. Chronic low back pain has a marked impact on a patient's quality of life and ability to engage in leisure activities and paid work. Moreover, early retirement due to chronic disability represents a large burden on society through work days lost and social welfare payments made. Thus, effectively treating chronic low back pain benefits both the individual patient and society as a whole. As described in more detail below, there are many non-surgical, 'conservative' treatment options for individuals with chronic low back pain. However, for a significant proportion of patients low back pain can be refractory to conservative treatment. Depending on diagnosis, these refractory patients may be indicated for surgical decompression of the intervertebral discs. Although the outcomes associated with surgery are good, there are the attendant risks of surgery in general (eg, problems associated with anaesthesia, infection, scarring) and spinal surgery in particular (eg, neurological damage, paralysis, loss of visceral organ function). Therefore, if there is evidence of a non-invasive treatment for refractory chronic low back pain that is at least as effective as surgery, the new treatment could provide significant benefits to patients in terms of risks avoided. SAFETY: Detailed evidence on the safety and complication rates of the VAX-D table is lacking. EFFECTIVENESS: For patients with radiculopathy or radicular pain associated with a herniated intervertebral disc, there is some evidence to suggest that surgical discectomy is more effective than VAX-D therapy at relieving pain in the short to medium term. No comparisons can be made between these two therapies in this patient group over the long term (ie, 10 years). For other patient groups (ie, patients with radiculopathy or radicular pain associated with degenerated intervertebral discs, and patients with non-specific low back pain) there is insufficient evidence to make any conclusions regarding the relative effectiveness of VAX-D therapy. COST-EFFECTIVENESS: No evidence-based conclusions can be drawn regarding the cost-effectiveness of VAX-D therapy in any patient group. However, it is likely that discectomy is more cost-effective than VAX-D therapy for the treatment of patients with radiculopathy or radicular pain associated with herniated intervertebral discs. OTHER CONSIDERATIONS: There are concerns regarding the qualifications of the person who would deliver VAX-D therapy. The applicant states that VAX-D therapy is to be delivered by a 'certified' VAX-D technician and implies that this technician may or may not be medically qualified. To be eligible for Medicare Benefits Schedule (MBS) funding, all treatments are either provided by a qualified medical practitioner or are provided under the supervision of a qualified medical practitioner. There is no intention in this report to consider the provision of VAX-D treatments under any other conditions. There are also serious concerns of access and equity. As there is only one supplier of the VAX-D system in Australia, the company may be in a position to influence which doctors deliver the treatment and which patients receive treatment. RECOMMENDATION: Since there is currently insufficient evidence pertaining to the effectiveness of vertebral axial decompression (VAX-D) therapy, MSAC recommended that public funding should not be supported at this time for this procedure. The Minister for Health and Aged Care accepted this recommendation on 19 June 2001.

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