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Please use this identifier to cite or link to this item: http://hdl.handle.net/11055/577
Title: Results From the Partnership for Advancement in Neuromodulation Registry: A 24-Month Follow-Up
Authors: Deer, Timothy R
Skaribas, Ioannis
McJunkin, Tory
Nelson,Christopher
Salmon, John
Darnule, Amit
Braswell, John J
Russo, Marc
Gomezese, Omar F
Anzca Brief Name: Russo, M
Keywords: chronic pain
clinical trial
registry
spinal cord stimulation
Issue Date: 18-Feb-2016
Citation: 19(2):179-187
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.
URI: http://hdl.handle.net/11055/577
DOI: 10.1111/ner.12378
PubMed URL: https://www.ncbi.nlm.nih.gov/pubmed/26890015
Journal Title: Neuromodulation: Technology at the Neural Interface
Type: Journal Article
Affiliates: Center for Pain Relief, Charleston, WV, USA
Greater Houston Pain Consultants, U.S. Anesthesia Partners, Houston, TX, USA
Arizona Pain Specialists, Scottsdale, AZ, USA
Bluegrass Pain Consultants, Louisville, KY, USA
PainCare Network, Perth Western, Australia
Spine Team Texas, Southlake, TX, USA
The Spine Diagnostic and Pain Treatment Center, Baton Rouge, LA, USA
Hunter Pain Clinic, Newcastle, NSW, Australia
Fundacion Cardiovascular de Colombia, Bucaramanga Santander, Colombia
Study/Trial: Prospective Cohort Study
Appears in Collections:Scholarly and Clinical

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