July 20, 2015
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Tailored spinal cord stimulation system improved outcomes, pain relief

Results showed paddle leads can possibly reduce opioid use by 78% and reduce pain at 1year follow-up.

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WASHINGTON, — Spinal cord stimulation systems can be tailored to treat patient-specific chronic pain and improve clinical outcomes, according to data presented at the American Association of Neurological Surgeons Annual Meeting.

“Various factors impact spinal cord stimulator (SCS) clinical outcomes, and these results indicate that one such factor is investigator tailoring of the system characteristics,” Vipul Vikrambhai Patel, MD, said. “Greater variation by investigators of lead type, number and dermal targeting generally correspond to improved clinical outcomes at 6 and 12 months. The improved outcomes may be possible with matching spinal cord stimulator characteristics to patients’ specific disease states.”

Current treatment guidelines do not specify how tailoring an SCS system can target a patient’s specific pain characteristics, Patel said. Therefore, the objective of the study was to determine the impact of investigator-based tailoring of SCS systems on all clinical outcomes.

Tailoring for pain specifics

Patel and colleagues used data from the St. Jude Medical EMP3OWER prospective, multicenter, post-market study. In the study, which was partially funded by St. Jude Medical, follow-up data were available for 350 patients who were implanted with a permanent SCS at 36 investigational sites. Most patients had been diagnosed with failed back surgery syndrome or radiculopathy. Variation in the placement of the SCS was on the number, type and location of leads, which was used to calculate a fraction of unlike comparison score. Clinical outcomes were evaluated at 3, 6 and 12 months after implantation and included a percentage of pain relief, percentage of change in pain relief from preimplantation and change in opioid use.

The fraction of unlike patient comparisons scores was calculated using the number of patient pairs with non-matching characteristics over the total number of comparisons made, according to Patel.

Opioid use reduction

Patel said the percentages of paddle leads and percutaneous placed were 54% and 45%, respectively across all sites, with an average of 11.2 patients per site.

For the percutaneous leads, the researchers found a 10% increase in the unlike comparison score, which correlated to a 47% increase in the odds of reducing opioid usage at 6 months. For paddle leads, there was a 10% increase in unlike comparison score, which led to a 78% increased odds of reduced opioid usage at 12-month follow-up, according to the researchers. – by Kristine Houck, MA, ELS, and Robert Linnehan

Disclosure: Patel reports the study was supported in part by St. Jude Medical.