Subcutaneous peripheral nerve stimulation with inter-lead stimulation for axial neck and low back pain: case series and review of the literature.

OBJECTIVES: While pain in the extremities often responds to treatment using spinal cord stimulation (SCS), axial pain is notoriously refractory to SCS. Interest in subcutaneous peripheral nerve stimulation (SQ PNS) as an alternative to SCS has emerged, but the most appropriate electrode locations and neurostimulator programming techniques are not yet clear. METHODS: A retrospective review was conducted of consecutive patients evaluated from August 2009 to December 2010 who had undergone trial of SQ PNS with inter-lead stimulation for axial spine pain. Patients proceeding to implant were followed postoperatively with routine clinical visits and a survey form at last follow-up. Ultrasound was used intraoperatively to ensure placement of electrodes at the appropriate depth in patients with larger body mass index. Primary outcome was patient-reported pain relief at last follow-up. Literature review was conducted by searching MEDLINE (1948-present) and through an unstructured review by the authors. RESULTS: Ten patients underwent trial of SQ PNS and six proceeded to permanent implantation. Fifty percent (3/6) of implanted patients preferred neurostimulation programming that included inter-lead stimulation ("cross-talk"). Average duration of postoperative follow-up was 4.5 months (range 2-9 months). Average patient-reported pain relief at last follow-up was 45% (range 20-80%). One patient required re-operation for migration. Patients not proceeding to implant had paresthesia coverage but no analgesia. CONCLUSION: SQ PNS is a promising therapy for axial neck and back pain based on a small cohort of patients. Ultrasound was useful to assist with electrode placement at the most appropriate depth beneath the skin. While inter-lead stimulation has been preferred by patients in published reports, we did not find it clearly influenced pain relief. Future investigations should include a randomized, controlled study design, as well as defined implantation technique and neurostimulator programming algorithms.

Mortality associated with implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain.

BACKGROUND: In 2006, the authors observed a cluster of three deaths, which circumstances suggested were opioid-related, within 1 day after placement of intrathecal opioid pumps for noncancer pain. Further investigation suggested that mortality among such patients was higher than previously appreciated. The authors performed investigations to quantify that mortality and compare the results to control populations, including spinal cord stimulation and low back surgery. METHODS: After analyzing nine index cases--three sentinel cases and six identified by a prospective strategy--the authors used epidemiological methods to investigate whether mortality rates reflected patient- or therapy-related differences. Mortality rates after intrathecal opioid therapy and spinal cord stimulation were derived by correlating Medtronic device registration data with de-identified data from the Social Security Death Master File. Aggregate demographic and comorbidity data were obtained from Medicare and United Healthcare population databases to examine the influence of demographics and comorbidities on mortality. RESULTS: Device registration and Social Security analyses revealed an intrathecal opioid therapy mortality rate of 0.088% at 3 days after implantation, 0.39% at 1 month, and 3.89% at 1 yr-a higher mortality than after spinal cord stimulation implants or after lumbar diskectomy in community hospitals. Demographic, illness profile, and mortality analyses of large databases suggest, despite limitations, that excess mortality was related to intrathecal opioid therapy, and could not be fully explained by other factors. These findings were consistent with the nine index cases that revealed that respiratory arrest caused or contributed to death in all patients. No device malfunctions associated with overinfusion were identified among cases where data were available. CONCLUSIONS: Patients with noncancer pain treated with intrathecal opioid therapy experience increased mortality compared to similar patients treated by using other therapies. Respiratory depression as a consequence of intrathecal drug overdosage or mixed intrathecal and systemic drug interactions is one plausible, but hypothetical mechanism. The exact causes for patient deaths and the proportion of those deaths attributable to intrathecal opioid therapy remain to be determined. These findings, although based on incomplete information, suggest that it may be possible to reduce mortality in noncancer intrathecal opioid therapy patients.