1. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.
- Author
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Deer, Timothy R., Falowski, Steven M., Moore, Gregory A., Hutcheson, J. Kelby, Pena, Isaac, Candido, Kenneth, Cornidez, Eric G., Fraunberg, von und zu, Blomme, Bram, Capobianco, Robyn A., and Peña, Isaac
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SPINAL cord , *PSYCHOSOCIAL functioning , *PAIN management , *PSYCHOLOGICAL distress , *QUALITY of life , *PAIN - Abstract
Study Design: Prospective, international, multicenter, single-arm, post-market study.Objective: The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261).Summary Of Background Data: Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing.Methods: After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months.Results: Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events.Conclusion: Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]- Published
- 2022
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