- Title
- Results from the partnership for advancement in neuromodulation registry: a 24-month follow-up
- Creator
- Deer, Timothy; Skaribas, Ioannis; McJunkin, Tory; Nelson, Christopher; Salmon, John; Darnule, Amit; Braswell, John; Russo, Marc; Fernando Gomezese, Omar
- Relation
- Neuromodulation Vol. 19, Issue 2, p. 179-186
- Publisher Link
- http://dx.doi.org/10.1111/ner.12378
- Publisher
- Wiley-Blackwell Publishing
- Resource Type
- journal article
- Date
- 2016
- Description
- 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
- chronic pain; clinical trial; registry; spinal cord stimulation
- Identifier
- http://hdl.handle.net/1959.13/1346127
- Identifier
- uon:29789
- Identifier
- ISSN:1094-7159
- Language
- eng
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