Subjects: Nine patients (6F, 3M), mean age 15 years, were operated on between 1994–2000. This heterogeneous patient group consisted of five cases of spinal dysraphism, one prune belly syndrome, one arthrogryposis, one myotonic dystrophy and one congenital myopathic dystrophy (muscle-eye-brain-syndrome). All patients were
INTRODUCTION: Intradiscal electrothermal therapy (IDET) is being used increasingly as a minimally-invasive treatment for chronic discogenic low back pain, with success reported in up to 70% of cases. The mechanism of action however is poorly understood. Proposed mechanisms include the contraction of collagen and the coagulation of annular nociceptors. An ovine model was used to assess the innervation of peripheral posterolateral annular lesions and the potential for IDET to denervate this region. METHODS: Posterolateral annular incisions were made in 36 lumbar discs of 18 sheep. After twelve weeks the sheep underwent IDET at one level and a sham treatment at the other level. IDET was performed using a modified intradiscal catheter (SpineCATHTM, Oratec Interventions Inc., Menlo Park, CA). Temperatures were recorded in the nucleus and the posterior annulus. The spines were harvested at intervals of up to eighteen months. Histological sections of the discs were stained with haematoxylin and eosin and an antibody to the general neuronal marker PGP 9.5. RESULTS: The target temperature of 90°C at the catheter tip was reached in all cases. The mean maximum TPa was 63.6°C and the mean maximum TN was 67.8°C. Vascular granulation tissue consistent with a healing response was observed in the region of the posterior annulus tear of all incised discs from 12 weeks. PGP 9.5 positive nerve fibres were clearly identified in the adjacent periannular tissue, but were scarce within the outer few lamellae of the annulus. There were no fewer nerve fibres identified in those specimens that had undergone IDET. From six weeks after IDET there was evidence of thermal necrosis in the inner annulus, sparing the periphery of the disc. DISCUSSION: IDET delivered at 90°C in the sheep consistently heats the posterior annulus and the nucleus to a temperature associated with coagulation of nociceptors and collagen contraction. Thermal necrosis was observed within the inner annulus from six weeks after IDET. In this model IDET did not appear to produce denervation of the posterior annular lesion.
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 randomised 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 for the study. Inclusion criteria included the presence of one or two level symptomatic disc degeneration with posterior or posterolateral 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 randomised 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 patient were blinded to the treatment. Patients followed a standard post-procedural rehabilitation programme. OUTCOME MEASURES: 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) RESULTS: Two subjects withdrew from the study (both IDET). Baseline demographic data, employment and worker’s compensation status, sitting tolerance, initial LBOS, ODI, SF-36, ZDI and MSPQ were similar for both groups. 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. DISCUSSION: 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. This study demonstrates no significant benefit from IDET over placebo.
Introduction: Although the ultrasound diagnosis of neural tube defects has been described extensively, anomalies of the fetal vertebral bodies have received little attention. This study aims to document the incidence of congenital hemivertebrae, the association with defects of other organ systems and discuss the outcome. Methods: All fetuses with ultrasonographically detected vertebral anomalies presenting to the above institution over a four year period were included in the study. Those with open neural tube defects were excluded. The level and Cobb angle (where possible) were estimated from the 18 week scan. Associated congenital anomalies were noted. Radiographs were taken soon after birth and checked for accuracy of original diagnosis and patients were monitored for curve progression. Results: Fourteen fetuses with congenital hemivertebrae were found from a total of 12,000 routine antenatal scans. Maternal age ranged from 22–32 years (mean 26.8 years) with an average term of 36.3 weeks (range 29–40). Only two fetuses were born prematurely: one at 33 weeks as part of a twin gestation (only one of the twins had an isolated hemivertebrae) and the other at 29 weeks via emergency caesarian section for fetal distress. This pregnancy was complicated by the oligohydramnios sequence (Potter syndrome). Ten of 14 fetuses had an isolated hemivertebrae. Two had VATER association (oesophageal and anal atresia) and two had multiple mosaic type congenital scoliosis, one of which had associated rib and abdominal wall malformation. All pregnancies resulted in live births. All except one child remain well at latest follow-up (average 25 months). The infant born at 29 weeks has had multiple complications of prematurity. Vertebral anomalies appeared in the thoracic spine in five, the lumbar spine in eight and the sacrum in one resulting in scoliosis in 13 and kyphosis in one. The average antenatal Cobb angle was 30°. The average postnatal Cobb angle was 32° (range 18–42). Accuracy of localisation (level and type) was good with only one error due to inability to see the S1 hemivertebrae. Six of the 14 had surgery before the age of 24 months, with the youngest aged three months. In this group the average pre-operative Cobb angle was 35° (range 25–42°). Three patients had anterior and posterior fusion in-situ without instrumentation. Three patients had hemivertebrectomy with correction and posterior instrumentation of the spine. Conclusion: In general sonographically detected isolated fetal hemivertebrae carry a good prognosis. If associated with the oligohydramnios syndrome the fetus is at high risk. Ultrasound appears accurate in the diagnosis of both the level and type of congenital malformation. The value of early surgical management needs continued assessment.
To assess the potential for IDET to ablate nerve fibres in an experimentally induced peripheral annular lesion. Intradiscal electrothermal therapy (IDET) is being increasingly used as a minimally-invasive treatment for discogenic low back pain, with success reported in up to 70% of cases. One proposed mechanism of IDET is ablation reported in up to 70% of cases. One proposed mechanism of IDET is ablation of nerve fibres in the peripheral annulus. An ovine model was used to assess the innervation of peripheral annular lesions and the potential for IDET to denervate this region of the disc. Postero-lateral annular incisions were made in 32 lumbar discs of 16 sheep. At twelve weeks the sheep underwent IDET at one level and a sham treatment at the other level. IDET was performed using a modified Intradiscal Catheter (SpineCath, Oratec Interventions Inc., Menlo Park, CA). The spines were harvested at intervals up to six months. Histological sections of the discs were stained with H&
E and an antibody to the general neuronal marker PGP 9.5. Vascular granulation tissue consistent with a healing posterior annular tear was observed in all incised discs from 12 weeks, extending to an average depth of 850 μm at 0 weeks to 690 μm at 6 months. PGP 9.5 positive nerve fibres were clearly identified outside the discs but were scarce within the discs. Nerves were identified up to 300 μm inside the annulus, from the earliest time point, and there was a trend towards less innervation with time. There were no fewer nerve fibres identified in those specimens that had undergone IDET. Specimens obtained six weeks after IDET showed evidence of thermal necrosis in the inner annulus, sparing the periphery of the disc. The reported benefit from IDET appears to be related to factors other than denervation. Thermal necrosis within the annulus six weeks after IDET.