According to a paper published in the journal Neurochirurgie (Neurosurgery) on August 2014, there is a need for an international database to help standardise decision-making over whether to use spinal cord stimulation for FBSS, or Failed Back Surgery Syndrome.
The researchers, Rigoard and Slavin, noted that, when it comes to the use of SCS, current practice varies between different treatment centres, with most clinical decisions based on an individual diagnosis. Different tools to evaluate neurological function, and variable measures of pain relief not only mean that two different clinicians are likely to make different decisions regarding SCS implantation in a patient with FBSS, but that clinical trial data can be immensely confusing and confounding for those devising practice guidelines.
Wilful Ignorance or a Systematic Approach to Treating FBSS?
The range of SCS devices, which continues to grow as demand grows, is only increasing the confusion. This recent paper argues that physicians have three options: they can practice intentional ignorance to deal with this confusing mass of data; they can adopt a standardised practice based on available evidence; or they can use an alternative data-mining approach.
What these authors then did was to create an international prospective database under the auspices of the PROBACK project, a clinicians’ global network, to extract and analyse data taken from FBSS patients regarding their selection for treatment with SCS, the implantantion of a device, and the results at follow-up. In establishing this database, the hope is that health care providers will be better able to make a more rational decision based on comparative data.
Reassessing Data for Better Patient Care
The large-scale computational modeling/data mining approach would look at the SCS and peripheral nerve stimulation devices and redefine the indications for their use and their respective roles. Essentially, these authors see the database as bringing order to the current chaos of data on the use of these devices for treating FBSS.
These authors noted the impossibility of individually assessing each of the vast number of SCS devices available, given the expense and time needed for multiple randomised clinical trials. SCS devices are surgically implanted into the spine to disrupt abnormal nerve signal transmission and thereby relieve pain after FBSS. They can help patients to reduce their reliance of analgesic medications and may therefore help reduce the risks of poly-pharmacy and associated side effects of multiple drugs.
The data analysis focused on technical criteria including device coverage and performance, coverage and selectivity, and persistence of the long-term electrical response. They also focused on clinical criteria including comparative mapping of patients’ pain relief, the persistence of the long-term clinical response, and the safety and complications associated with each device. The researchers would perform an immediate analysis, including a cost analysis, and a computational analysis to determine the strength of any correlations of variables. The result would be a mathematical model to evaluate likely response to the SCS device in any given patient.
By creating an international prospective database, the purpose of the PROBACK project was to set up a process of extraction and comparative analysis of data derived from the selection, implantation and follow-up of candidates and patients treated with spinal cord stimulation for FBSS. This evaluation strategy should help each implanter and each health system in making better decisions regarding the treatment of patients with this complication of back surgery.