Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared With Conventional Medical Therapy for Chronic Pain

Abstract

ImportanceSpinal cord stimulators (SCSs) are increasingly used for the treatment of chronic pain. There is a need for studies with long-term follow-up.ObjectiveTo determine the comparative effectiveness and costs of SCSs compared with conventional medical management (CMM) in a large cohort of patients with chronic pain.Design, Setting, and ParticipantsThis was a 1:5 propensity-matched retrospective comparative effectiveness research analysis of insured individuals from April 1, 2016, to August 31, 2018. This study used administrative claims data, including longitudinal medical and pharmacy claims, from US commercial and Medicare Advantage enrollees 18 years or older in Optum Labs Data Warehouse. Patients with incident diagnosis codes for failed back surgery syndrome, complex regional pain syndrome, chronic pain syndrome, and other chronic postsurgical back and extremity pain were included in this study. Data were analyzed from February 1, 2021, to August 31, 2022.ExposuresSCSs or CMM.Main Outcomes and MeasuresSurrogate measures for primary chronic pain treatment modalities, including pharmacologic and nonpharmacologic pain interventions (epidural and facet corticosteroid injections, radiofrequency ablation, and spine surgery), as well as total costs.ResultsIn the propensity-matched population of 7560 patients, mean (SD) age was 63.5 (12.5) years, 3080 (40.7%) were male, and 4480 (59.3%) were female. Among matched patients, during the first 12 months, patients treated with SCSs had higher odds of chronic opioid use (adjusted odds ratio [aOR], 1.14; 95% CI, 1.01-1.29) compared with patients treated with CMM but lower odds of epidural and facet corticosteroid injections (aOR, 0.44; 95% CI, 0.39-0.51), radiofrequency ablation (aOR, 0.57; 95% CI, 0.44-0.72), and spine surgery (aOR, 0.72; 95% CI, 0.61-0.85). During months 13 to 24, there was no significant difference in chronic opioid use (aOR, 1.06; 95% CI, 0.94-1.20), epidural and facet corticosteroid injections (aOR, 1.00; 95% CI, 0.87-1.14), radiofrequency ablation (aOR, 0.84; 95% CI, 0.66-1.09), or spine surgery (aOR, 0.91; 95% CI, 0.75-1.09) with SCS use compared with CMM. Overall, 226 of 1260 patients (17.9%) treated with SCS experienced SCS-related complications within 2 years, and 279 of 1260 patients (22.1%) had device revisions and/or removals, which were not always for complications. Total costs of care in the first year were $39 000 higher with SCS than CMM and similar between SCS and CMM in the second year.Conclusions and RelevanceIn this large, real-world, comparative effectiveness research study comparing SCS and CMM for chronic pain, SCS placement was not associated with a reduction in opioid use or nonpharmacologic pain interventions at 2 years. SCS was associated with higher costs, and SCS-related complications were common.

Serious Issues in Authorship, Design, and Conclusions of JAMA Neurology Real-World Evidence Study on Spinal Cord Stimulation Outcomes and Costs as Compared to Conventional Medical Therapy

“…Figure 1 was adapted from the data in Table 1 and 2 of the JAMA Neurology article, illustrating the percentage of patients who underwent epidural steroid injections (ESIs) at baseline, 1–12M and 13–24M, respectively. 1 The conclusion in the text of the article is that there is no difference between the two groups in the 13–24M timeframe, yet the percentage of patients receiving ESIs decreased from 40% to 25% in both groups. This appears to demonstrate that patients in the SCS group, who have previously failed CMM, and patients early in the CMM treatment algorithm are both responding, which is not the conclusion drawn by the authors.…”

“…We read with interest Long-term Outcomes in Use of Opioids, Nonpharmacologic Pain Interventions, and Total Costs of Spinal Cord Stimulators Compared with Conventional Medical Therapy for Chronic Pain, published online in JAMA Neurology in December 2022, and identified numerous serious flaws which make it more misleading than informing. 1 Using real-world evidence (RWE) to probe the utility and cost-effectiveness of medical treatments and devices will potentially affect healthcare policies worldwide and can be a highly effective clinical decision-making tool. As with any clinical study however, bias, false assumptions, misrepresentations, missing data, and study design all play extremely important roles in determining the outcomes.…”

“…The study design is unclear, and Figure 2 in the JAMA Neurology article (the Appendix) 1 illustrates an entirely different study design than that described in the text in the Treatments section, with alternate index start dates (trial versus implant). This design confounds the fundamentals of propensity matching by violating the assumption that “treatment allocation must temporally precede the outcome of interest; this temporal sequence is fundamental to avoid reverse causation.” 3 In other words, the authors began the 2-year SCS clock with the trial, allowing up to 365 days to provide implantation, but crediting that entire 24-month period to the SCS group.…”

Spinal Cord Burst Stimulation vs Placebo Stimulation for Patients With Chronic Radicular Pain After Lumbar Spine Surgery—Reply

“…The most important difference in case selection from daily clinical practice at many centers was the exclusion of patients taking high doses of opioids, benzodiazepines, or both. These medications are associated with poorer surgical outcomes and higher back pain–related disability, and spinal cord stimulation does not effectively reduce their use …”

The Real-World Performance of Spinal Cord Stimulation for Chronic Pain: Dismal Results

“…The treatments in the control group included pain medications, radiofrequency ablation, epidural and facet injections, physical therapy, chiropractic, acupuncture, and spine surgery. (See Dhruva et al, 2022. )…”