Trial of Pregabalin for Acute and Chronic Sciatica.

BACKGROUND: Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. RESULTS: A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group. CONCLUSIONS: Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group. (Funded by the National Health and Medical Research Council of Australia; PRECISE Australian and New Zealand Clinical Trials Registry number, ACTRN12613000530729 .).

MRI findings are more common in selected patients with acute low back pain than controls?

PURPOSE: The purpose of this study is to investigate if lumbar disc pathology identified on MRI scans is more common in patients with acute, likely discogenic, low back pain than matched controls. METHODS: We compared rates of MRI findings between 30 cases with low back pain and 30 pain-free controls. Cases were patients presenting for care with likely discogenic low back pain (demonstrated centralisation with repeated movement testing), of moderate intensity and with minimal past history of back pain. Controls were matched for age, gender and past history of back pain. Cases and controls underwent MRI scanning which was read for the presence of a range of MRI findings by two blinded assessors. RESULTS: The presence of disc degeneration, modic changes and disc herniation significantly altered the odds of a participant being a case or control. For example subjects were 5.2 times more likely to be a case than a control when disc degeneration grade of ≥3 was present, and 6.0 times more likely with modic changes. The presence of a high-intensity zone or annular tear was found to significantly alter odds for one assessor but not the other assessor. CONCLUSION: MRI findings including disc degeneration, modic changes and herniation are more common in selected people with current acute (likely discogenic) low back pain than in controls without current low back pain. Further investigation of the value of MRI findings as prognostic factors and as treatment effect modifiers is required to assess the potential clinical importance of these findings.

A novel operative technique to manage a symptomatic synovial cyst associated with an os odontoideum.

Synovial cysts in association with an os odontoideum are rare. All previous cases have been treated via a posterior approach with good results. The authors present a patient with a synovial cyst in association with an os odontoideum and discuss a planned two-stage procedure to excise the cyst via a neuronavigation-assisted transoral-transpharyngeal approach, followed by a posterior C1/2 fixation.

A cluster of nocardial brain abscesses.

BACKGROUND: Nocardia species are aerobic Gram-positive bacteria that are ubiquitous in the environment. Infection usually occurs through inhalation or direct cutaneous inoculation of the organism. It has been reported that infection is more common in warm, dry climates. Cerebral nocardiosis is an uncommon clinical entity, representing only 2% of all cerebral abscesses. It is an illness associated with significant morbidity and mortality. CASE DESCRIPTIONS: We report 4 cases of nocardial brain abscesses presenting to TCH, Australia, within a 1-year period. All 4 cases occurred in men without any significant underlying immunocompromise. In 3 of the cases, the diagnosis was only established after craniotomy. All cases were given prolonged antimicrobial therapy. After more than 8 months of follow-up, there have been no deaths or treatment failures. There has been only one other case of nocardial brain abscess at TCH over the past 15 years. We review the current literature on cerebral nocardiosis. CONCLUSION: Nocardial brain abscesses are uncommonly encountered at our institution. This cluster of 4 cases over a 1-year period has therefore led us to postulate that the severe drought may be aiding in the transmission of the bacteria. The cases also emphasize the propensity of nocardial infections to mimic other conditions, particularly malignancy, which may lead to delays in appropriate surgical treatment and antimicrobial therapy. The diagnosis requires a high clinical index of suspicion, with early tissue and microbiological diagnosis. Prolonged antimicrobial therapy is required to prevent relapse of the infection.

Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation.

OBJECT: To assess the safety and efficacy of the DIAM implant, the authors compared the mean 12-month outcomes in patients who underwent lumbar surgery with DIAM placement and in those who underwent lumbar surgery only. METHODS: Of 62 patients who underwent simple lumbar surgery (laminectomy and/or microdiscectomy) in a 24-month period, 31 underwent concomitant surgical placement of a DIAM interspinous process spacer (33 devices total). Radiographic imaging, pain scores, and clinical assessments were obtained postoperatively to a mean of 12 months (range 8-25 months). Patients who did not undergo implantation of an interspinous process spacer (Group C) were compared with and stratified against patients who underwent placement of a DIAM implant (Group D). In Group D, no statistically significant differences were noted in anterior or posterior disc height when comparing patients pre- and postoperatively. Compared with Group C, a relative kyphosis of less than 2 degrees was noted on postoperative images obtained in Group D. No statistically significant differences in visual analog scale (VAS) pain scores or MacNab outcomes were noted between Groups C and D at a mean of 12 months of follow up. Complications in Group D included three intraoperative spinous process fractures and one infection. CONCLUSIONS: After simple lumbar surgery, the placement of a DIAM interspinous process spacer did not alter disc height or sagittal alignment at the mean 12-month follow-up interval. No adverse local or systemic reaction to the DIAM was noted. No difference in VAS or MacNab outcome scores was noted between the groups treated with or without the DIAM implants, particularly when the DIAM was used to alleviate low-back pain.

PRECISE--pregabalin in addition to usual care: statistical analysis plan.

BACKGROUND: Sciatica is a severe, disabling condition that lacks high quality evidence for effective treatment strategies. This a priori statistical analysis plan describes the methodology of analysis for the PRECISE study. METHODS/DESIGN: PRECISE is a prospectively registered, double blind, randomised placebo controlled trial of pregabalin compared to placebo, in addition to usual care in patients with sciatica. The aim of this study is to determine the efficacy and cost-effectiveness of pregabalin in reducing leg pain intensity (primary outcome). Secondary outcomes include disability (key secondary), back pain intensity, quality of life, participants' perceived global effect, work absenteeism and health utilisation. Information about medication usage and tolerability are also collected. Outcomes are collected over one year (weeks 2, 4, 8, 12, 26 and 52). Double data entry will be conducted for primary and key secondary outcomes. Other outcomes will be checked using a risk-based approach. Analyses will be consistent with the intention-to-treat principle. Statistical tests will be two-tailed with a p value <0.05 considered significant. Group allocation will remain masked until analyses and interpretation are finalised. Repeated-measure linear mixed models will assess the effect of treatment (pregabalin versus placebo) on primary and secondary outcomes at all time points. Fixed effects will include group allocation, visit as a categorical variable and the interaction between group and visit. Covariates will include baseline leg pain and symptom duration, with an interaction term between baseline leg pain and visit. Pairwise differences between groups will be tested at weeks 8 and 52. The number of serious adverse events and adverse events will be reported, and the proportion of patients per group who have at least one event will be compared using Fisher's exact test. An economic evaluation will be conducted if there is a treatment effect on the primary outcome at week 8. A subgroup analysis will assess whether presenting features of neuropathic pain at baseline modify the treatment effect of leg pain at week 8. DISCUSSION: This statistical analysis plan provides detailed methodology for the analysis of the PRECISE study, which aims to deliver much needed evidence about effective and affordable management of sciatica. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12613000530729. Registered 13 May 2013).

Tension pneumocephalus and oxygen emboli from hydrogen peroxide irrigation.

Hydrogen peroxide irrigation is commonly utilised in neurosurgical and non-neurosurgical procedures for its bacteriocidal and haemostatic effects, however it has been associated with devastating complications such as tension pneumocephalus, O2 embolism and even dysrhythmias. We report a patient who suffered hydrogen peroxide-related mortality due to widespread tension pneumocephalus and O2 emboli.

PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

BACKGROUND: Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. METHODS/DESIGN: PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. DISCUSSION: This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica. TRIAL REGISTRATION: ClinicalTrial.gov, ACTRN 12613000530729.

Clinical accuracy of fluoroscopic computer-assisted pedicle screw fixation: a CT analysis.

STUDY DESIGN: Observational cohort study with computerized tomography (CT) analysis of in vivo pedicle screw placement. OBJECTIVE: To evaluate the clinical accuracy of computer-assisted fluoroscopy for the placement of thoracic and lumbosacral (LS) pedicle screws. SUMMARY OF BACKGROUND DATA: Computer-assisted fluoroscopy is an adjunct for the placement of pedicle screws. METHODS: Postoperative CT of 360 titanium pedicle screws (281 LS [L1-S1]; 79 thoracic [T2-T12]) were independently assessed. All screws were placed using the FluoroNav system (Medtronic Surgical Navigation Technologies, Louisville, CO). The relative position of the screw to the pedicle was graded as follows: A = completely in; B = <2 mm breach; C = 2-4 mm breach; and D = >4 mm breach. If an osseous breach occurred, the direction of the breach was further classified. RESULTS: Eight-five percent of screws were completely contained within the pedicle. Fifty-five-pedicle breaches (25 medial; 30 lateral) occurred. Pedicle breaches were graded B in 13.1% (47 breaches), C in 1.9% (7), and D in 0.3% (1) of screws. Pedicle breach was significantly higher in the thoracic compared to the LS spine, 31.6% (25/79) and 10.6% (30/281), respectively (P < 0.0001). In the thoracic spine, 72% of pedicle breaches were lateral. In 49% of breaches, the screw diameter was larger than the pedicle diameter. None of the pedicle breaches were associated with neurologic or other clinical sequelae. CONCLUSIONS: The clinical pedicle breach rate in this study is comparable to those reported using conventional techniques with or without fluoroscopic assistance. FluoroNav appears to be a safe adjunct for the placement of thoracic and LS pedicle screws.