Abstract
Introduction Intra-Discal Electrothermal Therapy (IDET) has been proposed as a treatment for chronic discogenic low back pain. Reports from prospective outcome studies demonstrate statistically significant improvements, but to date there are no published randomized controlled trials assessing efficacy versus a placebo group.
Methods Ethical committee approval was obtained prior to the study. Patients with chronic low back pain who failed to improve with conservative therapy were considered. Inclusion criteria included the presence of one or two level symptomatic disc degeneration with posterior or postero-lateral annular tears as determined by provocative CT/discography. Patients were excluded if there was > 50% loss of disc height or previous back surgery. Fifty-seven patients were randomized with a 2:1 (IDET: Placebo) ratio, 38 to the active IDET arm and 19 to the sham procedure (placebo). In all cases the IDET catheter was positioned under sedation to cover at least 70% of the annular tear defined by the CT/discogram. An independent technician connected the catheter to the generator and either delivered electrothermal energy (active group) or did not (sham group). Both surgeon and patients were blinded to the treatment. Patients followed a standard post-procedural rehabilitation programme. Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), SF-36 questionnaire, Zung Depression Index (ZDI) and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and six months. Successful outcome was defined as: no neurological deficit resulting from the procedure, improvement in LBOS of > 7 points, improvements in SF-36 subsets (pain/disability, physical functioning and bodily pain). Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and workers’ compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups.
Results No neurological deficits occurred as a result of either procedure. No subject in either treatment arm showed improvement of > 7 points in LBOS or specified domains of the SF-36. Mean ODI was 41.4 at baseline and 39.7 at six months for the IDET group compared to 40.7 at baseline and 41.5 at six months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. No subject in either treatment arm met criteria for successful outcome. Further analysis showed no significant change in outcome measures in either group at six months.
Conclusions This study demonstrates no significant benefit from IDET over placebo.
The abstracts were prepared by Mr Jerzy Sikorski. Correspondence should be addressed to him at the Australian Orthopaedic Association, Ground Floor, William Bland Centre, 229 Macquarie Street, Sydney NSW 2000, Australia.
None of the authors have received any payment or consideration from any source for the conduct of this study.
