Study Does Not Support Spinal Cord Stimulation Over Usual Care for Chronic Pain

In the setting of chronic pain, the use of spinal cord stimulators did not reduce opioid consumption, had a relatively high complication rate, and was associated with higher costs compared with conventional medical management. These findings from a comparative effectiveness study were published in JAMA Neurology.

Investigators from the University of California, San Francisco School of Medicine used data sourced from the Optum Labs Data Warehouse to assess the benefits, risks, and cost effectiveness of spinal cord stimulation among patients with chronic pain. Patients (N=92,726) with chronic pain who underwent placement of spinal cord stimulators (n=1419) between 2015 and 2020 were propensity matched using 65 variables in a 1:5 ratio with patients who received conventional medical management (n=91,307) for final cohort sizes of 1260 and 6300, respectively. Conventional medical management consisted of medication, surgery, radiofrequency ablation, steroid injections, and conservative nonpharmacologic therapy such as physical therapy and acupuncture. The outcomes of interest were pain efficacy, safety, and cost. A surrogate for pain outcomes was the use of pharmacologic and surgical interventions.

The mean ages of patients in the prematched spinal cord stimulation and conventional medical management cohorts were 64.3 (standard deviation [SD], 11.9) and 61.9 (SD, 13.3) years, 60.5% and 60.8% were women, and 78.5% and 70.5% were White. Failed back surgery was reported in 72.5% and 23.8%, respectively; 28.1% and 69.4% had chronic pain, and 8.7% and 5.6% had complex regional pain.

After matching, the 2 groups at baseline each had a median of 4 opioid prescription fills, an average morphine milligram equivalents (MME) of 12.2 and 9.9 mg, and median opioid days of 90 and 74 days, respectively.

During the first 12 months of follow-up, spinal cord stimulation associated with higher MME use (odds ratio [OR], 1.81), chronic opioid use (OR, 1.14), and long-acting opioid use (OR, 1.28) and with less use of advanced imaging (OR, 0.84), spinal surgery (OR, 0.72), radiofrequency ablation (OR, 0.57), and epidural and facet corticosteroid injections (OR, 0.44) compared with conventional medical management. From month 13 to 24, spinal cord stimulation was associated with greater gabapentinoid (OR, 1.22) and tricyclic or serotonin and norepinephrine reuptake inhibitor antidepressant (OR, 1.16) use compared with conventional medical management.

Among the recipients of a spinal cord stimulator, 17.9% had any complication with lead or generator during the 24-month follow-up. The most common type of complication was other mechanical complications. More than one-fifth of recipients (22.1%) underwent removal or revision interventions for the spinal cord stimulator. The most common procedure was revision.

For health care utilization outcomes, monthly costs during the first year were $5531 for the spinal cord stimulation group compared with $2240 for those receiving conventional medical management (P <.001). During the first year, spinal cord stimulation (SCS) was associated with more than $39,000 higher health care costs compared with conventional medical management. No significant difference was observed during the second 12 months.

This study may have been limited by not having access to pain score data.

Study authors concluded, “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. 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.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.