IDET: a critical appraisal of the evidence.

Smith and Nephew (Endoscopy division, Andover, MA, USA) have estimated that 60,000 Intra-Discal Electrothermal Therapy (IDET) procedures have been performed world wide up to June 2005. Despite the large number of procedures performed, a critical appraisal of the evidence of efficacy of IDET has not appeared in the literature. This paper reviews the current evidence of clinical efficacy for IDET obtained via a systematic review of the literature. Studies were included if they used at least one of four specified primary outcome measures; pain intensity as assessed by a visual analogue score (VAS), global measurement of overall improvement, back specific functional status such as Oswestry disability Index (ODI) and return to work. Levels of evidence were assigned according to the hierarchy described by the Oxford Centre for Evidence-Based Medicine (www.cebm.net). Papers addressing possible mechanisms of action of IDET were not considered as the focus of the literature review was clinical effectiveness. Eleven prospective cohort studies (level II evidence) were reported on a total of 256 patients with a mean follow-up of 17.1 months (range 12-28 months). The mean improvement in the VAS for back pain was 3.4 points (range 1.4-6.5) and the mean improvement in ODI was 5.2 points (range 4.0-6.4). A total of 379 patients were reported in five retrospective studies (level III evidence). Between 13 and 23% of patients subsequently underwent surgery for low back pain within the study period. Two randomised controlled trials of IDET have been reported in the literature. The first randomised 64 patients (37 to IDET, 27 to Sham). The advantage for IDET patients amounted to 1.3 points on the VAS and seven points on the ODI. The second study randomised 57 subjects (38 to IDET, 19 to Sham) and showed no benefit from IDET over placebo. The evidence for efficacy of IDET remains weak and has not passed the standard of scientific proof.