10 kHz spinal cord stimulation: a retrospective analysis of real-world data from a community-based, interdisciplinary pain facility

Abstract

ObjectiveTo evaluate clinical outcomes and health care utilization at 12 months post spinal cord stimulator (SCS) implantation compared with baseline and a matched sample of patients receiving conventional medical management (CMM) for the treatment of low back and lower extremity pain.PatientsA retrospective study of patients with at least 24 months of active treatment at an interdisciplinary community pain center between December 1, 2014 and December 31, 2017. Thirty-two patients receiving implantation of a high-frequency (10 kHz) SCS and 64 patients receiving CMM were identified through propensity matching at a ratio of 2:1.MethodsData were extracted from medical records, including pain severity, prescribed opioid dose in morphine milligram equivalents, patient perception of disability, and volume of interventional pain procedures and total office visits to the pain center.ResultsReductions in opioid dose were significantly greater for the SCS group than the CMM group. The 26.2 mg morphine equivalent dose reduction represents a 28% reduction from baseline, with 71.4% of those prescribed opioids in the SCS group reducing their dose at 12 months post-implant. Among those with SCS, there were significant within-group reductions in numerical pain score for low back and lower extremity pain, reducing by 46.2% and 50.9% from baseline, respectively. Change in functional pain score was not significant for either SCS group or CMM. Both groups had significant within-group reduction in disability. Reduction of interventional procedure volume was significant for both groups with a greater reduction observed in the SCS group. Office visit volume reduction was significant for the CMM group, but this was not a significant difference from the SCS group.ConclusionsResults support the efficacy of 10 kHz SCS for analgesia, reduction of opioid utilization, reduction of interventional pain procedures, and patient perception of disability.

Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

“…It is important to note that, excepting studies by DiBenedetto et al . and Al‐Kaisy et al ., the reductions in opioid use reported here were spontaneous, observational outcomes of the respective studies . It is therefore readily conceivable that pain treatment with 10 kHz SCS in conjunction with a targeted strategy to reduce conventional opioid use could achieve greater decreases and/or higher rates of abstinence than those reported here.…”

“…These results were strengthened by the SENZA‐RCT trial in subjects with low back pain, which showed that 10 kHz SCS reduced mean back pain by 67% and leg pain by 65% for at least 24 months and was associated with a 19% reduction in daily opioid consumption after 12 months, whereas traditional SCS was associated with only 1% reduction in daily opioid consumption ( P = 0.014, difference between groups) . Retrospective reviews of real‐world data in patients with chronic back pain also found pain reductions in the range of 45–63%, as well as decreases in opioid requirements and increases in opioid abstinence …”

“…Furthermore, in their analysis of the SENZA‐RCT results, the authors concluded that the significant benefits and low risks of 10 kHz SCS relative to alternative treatments suggested that economic benefits might be associated with this treatment modality . Likewise, other investigators suggested that improvements in quality of life measures or reductions in conventional opioid use should result in lower long‐term healthcare costs. Finally, the finding by DiBenedetto and colleagues that patients treated with 10 kHz SCS required fewer interventional procedures than matched controls provides further support for the possible financial benefits of the treatment …”

“…Likewise, other investigators suggested that improvements in quality of life measures or reductions in conventional opioid use should result in lower long‐term healthcare costs. Finally, the finding by DiBenedetto and colleagues that patients treated with 10 kHz SCS required fewer interventional procedures than matched controls provides further support for the possible financial benefits of the treatment …”

Pain relief and improvement in quality of life with 10 kHz SCS therapy: Summary of clinical evidence

“…The smaller of the two studies was conducted in a single center. DiBenedetto and associates compared opioid consumption and procedural volume in 32 patients receiving 10 kHz SCS plus conventional medical management (CMM) with 64 case‐matched controls receiving only CMM . The study found a decrease in MEDD from baseline to 12 months only among 10 kHz SCS + CMM patients (92.2 to 66.0 mg/d, P = .001, N = 21).…”