A Prospective, Randomised, Double-blind, Placebo-controlled Study to Examine the Effectiveness of Burst Spinal Cord Stimulation Patterns for the Treatment of Failed Back Surgery Syndrome

Spinal cord stimulation (SCS) for the treatment of chronic pain is a well-established therapy. However, the requirement that paresthesia be continually felt by the patient has important downsides.
Twenty patients with failed back surgery syndrome (FBSS) and a preexisting SCS system each received three treatment allocations in random order for a period of one week: 500-Hz tonic stimulation, burst stimulation, and placebo stimulation. The primary outcome measure was pain intensity measured on a numerical rating scale (NRS). Secondary outcome measures were pain quality measured using the Short Form McGill Pain Questionnaire (SFMPQ) and safety. Additional data were collected relating to pain-related disability measured using the Oswestry Disability Index (ODI).
The lowest mean NRS and SFMPQ scores were observed under burst stimulation. For the burst stimulation treatment group, mean NRS and SFMPQ scores were significantly decreased compared with the other treatment groups. Mean NRS and SFMPQ scores were not significantly different between 500-Hz tonic stimulation and placebo stimulation. Although the lowest mean ODI score was observed under burst stimulation, no significant differences were found between the ODI categories. No adverse events occurred, and burst stimulation was significantly preferred by 16 patients (80%).
Overall, burst stimulation resulted in significantly better pain relief and improved pain quality in the short term compared with 500-Hz tonic stimulation and placebo stimulation and was preferred by the majority of patients 1).
1) Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A Prospective, Randomised, Double-blind, Placebo-controlled Study to Examine the Effectiveness of Burst Spinal Cord Stimulation Patterns for the Treatment of Failed Back Surgery Syndrome. Neuromodulation. 2014 Jul;17(5):443-50. doi: 10.1111/ner.12197.

Top Read: Simvastatin in aneurysmal subarachnoid haemorrhage (STASH): a multicentre randomised phase 3 trial.

Lancet Neurol. 2014 May 15. pii: S1474-4422(14)70084-5. doi: 10.1016/S1474-4422(14)70084-5. [Epub ahead of print]

Simvastatin in aneurysmal subarachnoid haemorrhage (STASH): a multicentre randomised phase 3 trial.

Abstract

BACKGROUND:

The benefit of statins in patients with acute aneurysmal subarachnoid haemorrhage is unclear. We aimed to determine whether simvastatin 40 mg could improve the long-term outcome in patients with this disorder.

METHODS:

In this international, multicentre, randomised, double-blind trial, we enrolled patients aged 18-65 years with confirmatory evidence of an aneurysmal subarachnoid haemorrhage and presenting less than 96 h from ictus from 35 acute neurosurgical centres in nine countries. Patients were randomly allocated (1:1) to receive either simvastatin 40 mg or placebo once a day for up to 21 days. We used a computer-generated randomisation code to randomise patients in every centre by blocks of ten (five simvastatin, five placebo). Participants and investigators were masked to treatment assignment. The primary outcome was the distribution of modified Rankin Scale (mRS) score obtained by questionnaire at 6 months. Analyses were done on the intention-to-treat population. This trial has been completed and is registered with Current Controlled Trials, number ISRCTN75948817.

FINDINGS:

Between Jan 6, 2007, and Feb 1, 2013, apart from the period between May 15, 2009, and Feb 8, 2011, when recruitment was on hold, 803 patients were randomly assigned to receive either simvastatin 40 mg (n=391) or placebo (n=412). All patients were included in the intention-to-treat population. 782 (97%) patients had outcome data recorded at 6 months, of whom 560 (72%) were classed as having a favourable outcome, mRS 0-2 (271 patients in the simvastatin group vs 289 in the placebo group). The primary ordinal analysis of the mRS, adjusted for age and World Federation of Neurological Surgeons grade on admission, gave a common odds ratio (OR) of 0·97, 95% CI 0·75-1·25; p=0·803. At 6 months, we recorded 37 (10%) deaths in the simvastatin group compared with 35 (9%) in the placebo group (log-rank p=0·592). 70 (18%) serious adverse events were reported in the simvastatin group compared with 74 (18%) in the placebo group. No suspected unexpected serious adverse reactions were reported.

INTERPRETATION:

The STASH trial did not detect any benefit in the use of simvastatin for long-term or short-term outcome in patients with aneurysmal subarachnoid haemorrhage. Despite demonstrating no safety concerns, we conclude that patients with subarachnoid haemorrhage should not be treated routinely with simvastatin during the acute stages.

FUNDING:

British Heart Foundation.

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