ABSTRACT
OBJECTIVE: This longitudinal, clinical outcome study was a multicenter, prospective, observational, registry with a 24-month assessment of patients implanted with spinal cord stimulation (SCS) systems for the management of chronic pain of the trunk and/or limbs. METHODS: On informed consent and institutional review board approval, 614 patients from 39 sites were enrolled within 30 days following permanent SCS system implantation. Medication usage, patient-reported pain relief (PRP), categorical ratings of pain relief, pain disability index scores (PDI), quality of life (QoL), and patient satisfaction were assessed at enrollment, 3-, 6-, 12-, 18-, and 24-month postimplant. Device-related adverse events (AEs) were recorded and reported. RESULTS: Across all visits, statistically significant improvements were reported on all outcome measures. Mean PRP was 58.5% (± 26.4) at 3 months, 56.8% (± 29.2) at 6 months, 57.7% (± 28.9) at 12 months, 55.6% (± 29.8) at 18 months, and 56.3% (± 30.3) at 24 months. More than 65% of patients at any visit reported a PRP ≥ 50%. Mean PDI scores reduced from 46.9 points at baseline to 32.7, 31.8, 31.5, 32.1, 32.1 points at 3, 6, 12, 18, and 24 months (p ≤ 0.0001), respectively. Greater than 76% of patients at any visit were satisfied with their therapy. The majority of patients categorized pain relief as excellent or good on a 5-item scale and reported overall QoL as greatly improved or improved on a 5-item scale. An average of 88% of patients stopped, decreased, or did not change dose of narcotics/opioids. The most common AE was diminished or loss of pain relief in 11.4% of enrolled patients. CONCLUSIONS: Most patients experienced substantial pain relief and a significant improvement in all outcome measures. These results further support the safety, efficacy, and sustainability of SCS in clinical practice.
Subject(s)
Chronic Pain/therapy , Product Surveillance, Postmarketing , Recovery of Function , Registries , Spinal Cord Stimulation , Female , Humans , Longitudinal Studies , Male , Patient Satisfaction , Treatment OutcomeABSTRACT
OBJECTIVE: A patient with postherpetic neuralgia (PHN) did not respond to medications, either singly or in combination, or to intrathecal methylprednisolone but responded to intrathecal alcohol. This evidenced-based case management article evaluates and grades the evidence for the prevention and treatment of PHN. METHODS: A search of published English-language studies on the prevention and treatment of PHN was made. RESULTS: Randomized clinical studies showed the efficacy of antiviral agents in the prevention of PHN and the use of anticonvulsants, antidepressants, opioids, and Lidoderm patch in the treatment of PHN (level A evidence). The role of epidural local anesthetic and steroid injections in preventing PHN has not been completely established (level B evidence). Intrathecal steroid injections and topical capsaicin may be effective in PHN (level B evidence). No randomized controlled study supports the usefulness of spinal cord stimulation and intrathecal alcohol. CONCLUSIONS: Postherpetic neuralgia should be managed pharmacologically. If not effective, intrathecal steroid injections or nerve blocks may be tried. Spinal cord stimulation or intrathecal alcohol should be used only as a last resort.