A randomized, double-blind, controlled trial : Intradiscal electrothermal therapy Versus placebo for the treatment of chronic discogenic low back pain

• Published in: Spine (Philadelphia, Pa. 1976) Pa. 1976), 2005-11, Vol.30 (21), p.2369-2378
• Main Authors: FREEMAN, Brian J. C, FRASOR, Robert D, CAIN, Christopher M. J, HALL, David J, CHAPPLE, David C. L, CAREY, Timothy S
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Cerebrospinal fluid. Meninges. Spinal cord; Electric Stimulation Therapy - methods; Female; Health Status; Humans; Hyperthermia, Induced - methods; Immunomodulators; Intervertebral Disc Displacement - complications; Intervertebral Disc Displacement - physiopathology; Intervertebral Disc Displacement - therapy; Low Back Pain - etiology; Low Back Pain - therapy; Lumbar Vertebrae - pathology; Male; Medical sciences; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis; Nervous system (semeiology, syndromes); Neurology; Pain Measurement; Pharmacology. Drug treatments; Severity of Illness Index; Treatment Outcome
• ISSN: 0362-2436; 1528-1159
• DOI: 10.1097/01.brs.0000186587.43373.f2

A prospective, randomized, double-blind, placebo-controlled trial of intradiscal electrothermal therapy (IDET) for the treatment of chronic discogenic low back pain (CDLBP). To test the safety and efficacy of IDET compared with a sham treatment (placebo). In North America alone, more than 40,000 intradiscal catheters have been used to treat CDLBP. The evidence for efficacy of IDET is weak coming from retrospective and prospective cohort studies providing only Class II and Class III evidence. There is one study published with Class I evidence. This demonstrates statistically significant improvements following IDET; however, the clinical significance of these improvements is questionable. Patients with CDLBP who failed to improve following conservative therapy were considered for this study. Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography (CT) discography. Patients were excluded if there was greater than 50% loss of disc height or previous spinal surgery. Fifty-seven patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham procedure (placebo). In all cases, the IDET catheter was positioned to cover at least 75% of the annular tear as defined by the CT discography. An independent technician connected the catheter to the generator and then either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. All patients followed a standard postprocedural rehabilitation program. Independent statistical analysis was performed. Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurologic deficit, improvement in LBOS of greater then 7 points, and improvement in SF-36 subsets (physical function and bodily pain) of greater than 1 standard deviation. Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ were similar for both groups. No neurologic deficits occurred. No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 standard deviation in the specified domains of the SF-36. Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared with 40.