Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage Following Burst Spinal Cord Stimulation.

OBJECTIVE: Burst spinal cord stimulation (B-SCS) has been shown to reduce neuronal firing in the anterior cingulate cortex through selective modulation of the medial pain pathway tract. This pain pathway communicates the affective component of pain processing. The purpose of this study was to assess the effect of B-SCS on psychosocial functioning and its influence on pain and quality of life. MATERIALS AND METHODS: Eligible patients with chronic, intractable pain of the trunk, and/or lower limbs were enrolled. After a successful trial period, subjects received a permanent implant and returned for follow-up at 6- and 12-months. RESULTS: In total, 269 patients were enrolled at 22 centers. Trial success rate was 90%. Significant improvements in pain, physical, mental, and emotional functioning were observed from baseline to the 6- and 12-month follow-up (p < 0.001). Overall, patients had improved quality of life, became more active, and the negative impact of pain on daily life was decreasing. At one year, 81% of subjects were satisfied or very satisfied with their therapy. Subjects showing significant improvements on mental health outcomes reported enhanced pain relief and quality of life scores compared with subjects with continued impaired mental health at follow-up. At one year, 89% of subjects who were taking opioids at baseline decreased or stayed at the same level of opioid use; 19% stopped taking any opioids. No unanticipated adverse events have been reported. CONCLUSIONS: One-year outcomes after B-SCS show improvements across all evaluated psychological measures with the largest impact observed on catastrophizing and depression (the affective component of pain processing). These pain-related beliefs and behaviors, and not pain intensity, have been shown to put patients at greatest risk of a poor prognosis and quality of life.

Spinal Cord Stimulation (SCS) Trial Outcomes After Conversion to a Multiple Waveform SCS System.

OBJECTIVE: Spinal cord stimulation (SCS) for chronic intractable pain is typically delivered in pulses, classically programmed between approximately 20 and 100 Hz. Though some recent studies suggest that better pain relief is obtained, with only 10 kHz stimulation, other studies show that single-therapy trials do not always lead to permanent implantation. We evaluated SCS outcomes in subjects given trials with multiple waveforms who did not experience satisfactory trial relief with 10 kHz stimulation only. METHODS: In this multicenter, open-label, real-world, observational study conducted in the United States, subjects reporting <50% pain relief with 10 kHz stimulation (i.e., failed the screening trial) received a stimulator capable of delivering multiple waveforms and/or field shapes. Pain relief and patient device preference data were collected. RESULTS: Twenty-two subjects were analyzed. Of the 16 who failed the 10 kHz trial and had numerical rating scale, visual analog scale, or percent pain relief scores available, 63% (n = 10) reported ≥50% relief with multiple waveform SCS. Additionally, 80% of subjects with ≥50% relief using multiple waveform SCS had experienced no relief with 10 kHz SCS. Among all subjects, 68% preferred multiple waveform SCS, none preferred 10 kHz SCS, and 32% had no preference. DISCUSSION: Subjects with failed SCS trials at 10 kHz experienced ≥50% relief after switching to a multiple waveform system. These results suggest that providing multiple waveforms during trials may overcome limitations of providing only 10 kHz stimulation. Thus, chronic pain's variable nature across patients and over time lends itself to variable treatment options.

Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.

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.