Authors' objectives:

This brief was prepared at the request of the Regie de l'assurance maladie du Quebec (RAMQ), which wanted to know if intradiscal electrothermal therapy for the treatment of chronic low back pain 'should still be considered experimental and, if so, what the prospects are of it becoming medically recognized'. The purpose of this assessment is therefore to determine if the currently available efficacy and safety evidence for intradiscal electrothermal therapy is sufficient for this treatment modality to no longer be considered as experimental.

Authors' results and conclusions: Over the past few years, a number of systematic health technology assessments have examined the efficacy and safety of intradiscal electrothermal therapy. Recent reports identified a small randomized study, a nonrandomized, controlled study, and several case series. Our own literature search, which continued up to April 2005, did not identify any other relevant studies. The efficacy evidence for this technology is therefore limited. In addition, the evidence on this procedure is difficult to interpret because of the natural history of chronic discogenic low back pain, the difficulty in assessing pain, the potential for placebo effect, and the paucity of long-term efficacy data. Given the weakness of the evidence, a number of assessments recommend not including intradiscal electrothermal therapy as an insured service, except in a research setting. However, the National Institute for Clinical Excellence (NICE) in the United Kingdom states that clinicians wishing to use this procedure should take special arrangements for consent and for audit or research. In Quebec, this type of practice framework corresponds to the classification of innovative technology. As for the safety of this procedure, all the assessments performed thus far conclude that it is acceptably safe. In Quebec, it seems that intradiscal electrothermal therapy is used only in Montreal. One private medical clinic offers this treatment to patients covered by the Commission de la sante et de la securite du travail (CSST) on the basis of a reimbursement rate of $4,820, which includes all the costs, except the physician's professional services. The Radiology Department at the Centre Hospitalier de l'Universite de Montreal (CHUM) offers this procedure to patients covered by the public plan.

Authors' recommendations: In order for a technology to be medically recognized, a judgment must be made about the level of evidence required for it to move from an experimental status to an innovative status. This judgment takes into account both the uncertainties regarding its efficacy and safety, and the necessity to sustain innovation to improve the quality of care. Especially in situations where the new technology is used to treat serious diseases for which there are few or no other treatments, assigning innovative status can be considered reasonable, even if this decision is based on limited evidence. However, this approval should be conditional upon field research being conducted to assess the effectiveness of the technology. In the present case, the lack of other proven treatments constitues an argument in favour of assigning an innovative status to intradiscal electrothermal therapy for the treatment of discogenic low back pain that does not respond to any type of conservative treatment, in particular, intensive multidisciplinary therapy. In addition, intradiscal electrothermal therapy is a much less invasive procedure than spinal fusion, which is presently considered an accepted technology, even if the evidence regarding its efficacy hardly seems any better than that for electrothermal therapy. The decision to include this technology as an insured service should be conditional upon it being used by appropriately trained physicians in medical settings where continuous evaluation and research are conducted and upon the creation of clinical registries for evaluating its effectiveness in Quebec. It would be desirable to include in these registries the spinal fusions performed for the treatment of chronic low back pain, in order to determine their effectiveness as well and to improve the overall quality of the treatment of chronic back pain in Quebec. These registries could be under the responsibility of university hospitals and of the integrated university health-care networks (IUHNs), which are presently being implemented in Quebec.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.aetmis.gouv.qc.ca/

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Agence d'évaluation des technologies et des modes d'intervention en santé

Contact Address: 2021, avenue Union, Bureau 10.083,Montreal, Quebec H3A S29, Canada.Tel: +1 514 873 2563; Fax: +1 514 873 1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Agence d'Evaluation des Technologies et des Modes d'Intervention en Sante (AETMIS)