Spinal Cord Stimulators for Chronic Pain May do More Harm than Good, Suggests Real-world Study

Use of spinal cord stimulators (SCSs) is not associated with reductions in opioid use or nonpharmacologic pain interventions, suggests findings from new real-world study published in JAMA Neurology.

In the large propensity-matched comparative effectiveness research analysis of insured persons with chronic pain, those treated with SCSs had higher odds of chronic opioid use during the first 12 months compared with those treated with conventional medical management (CMM) (adjusted odds ratio [aOR], 1.14; 95% CI, 1.01-1.29), according to researchers led by Sanket S. Dhruva, MD, MHS, of the University of California San Francisco School of Medicine.

Investigators also found that those treated with SCSs had lower odds of epidural and facet corticosteroid injections s (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 the first 12 months.

"The lack of reduction in pharmacotherapy, epidural and facet corticosteroid injections, and radiofrequency ablations at 2 years among patients receiving SCS compared with those receiving CMM suggests that SCS was providing insufficient pain relief to forego other therapies or improve rates of depression or anxiety, as prescriptions for these drug classes did not decline," wrote Dhruva and colleagues.

Despite increasing use of SCS, evidence of its superiority over usual care is limited, according to investigators. Most SCSs have been authorized by the US Food and Drug Administration without clinical data.

“Given the limitations in available data, there is a need for data in a larger, contemporary patient cohort to compare the long-term risks, benefits, and cost-effectiveness of SCSs with CMM,” wrote the team. Accordingly, their objective was to determine the comparative effectiveness and costs of SCSs compared with CMM in a large cohort of patients with chronic pain.

Researchers used administrative claims data on 7560 patients (mean age, 63.5 years; 59.3% women) who were diagnosed with failed back surgery syndrome, complex regional pain syndrome, chronic pain syndrome, or other chronic postsurgical back and extremity pain from April 2016 to August 2018. Participants were matched 1:5 to the SCS group (n=1260) or CMM (n=6300).

When researchers looked at 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.

Among the participants in the SCS group, 22.1% (n=226) experienced SCS-related complications within 2 years and 22.1% (n=279) had device revisions and/or removals, which were not always for complications, noted investigators.

Total costs of care in the first 12 months were $39 000 higher with SCS than with CMM and similar between SCS and CMM in year 2, added Dhruva and colleagues.

“Results of this large comparative effectiveness research study examining SCSs compared with CMM for chronic pain suggest a lack of clinical benefit for most patients and possible harm to some,” concluded Dhruva et al. “There may be opportunities to redeploy the high—and increasing—use and spending associated with SCS toward more evidence-based interventions for chronic pain relief.”

Reference: Dhruva SS, Murillo J, Ameli O, et al. 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. JAMA Neurol. Published online November 28, 2022. doi:10.1001/jamaneurol.2022.4166.