Use of spinal cord stimulation (SCM) is not associated with simplification successful opioid usage oregon nonpharmacologic symptom involution astatine 2 years, compared to accepted aesculapian absorption (CMM), and is associated with higher costs and complications, caller probe suggests. However, astatine slightest 1 adept says the survey has shortcomings.
In the retrospective study, researchers compared implicit 7500 matched patients who had received either SCM oregon CMM and recovered that during the archetypal 12 months, those treated with SCS had higher likelihood of semipermanent opioid usage but were little apt to acquisition procedures specified arsenic corticosteroid injections, radiofrequency ablation, and spinal surgery. During the 2nd year, determination was nary important quality betwixt the groups.
During the 2-year study, adjacent to 20% of those treated with SCS had SCS-related complications, and a small implicit a 5th underwent instrumentality revisions and/or removals. Total costs of attraction were dramatically higher for SCS than for CMM during the archetypal twelvemonth but were akin during the 2nd year.
"Our findings suggest that spinal cord stimulators adhd precocious outgo and person important hazard to patients; these devices are improbable to supply important symptom alleviation to patients suffering from chronic pain," pb writer Sanket S. Dhruva, MD, MHS, adjunct prof of medicine, University of California, San Francisco, School of Medicine, told Medscape Medical News.
"The objective accusation is that physicians should usage guideline-based nonpharmacologic therapy arsenic first-line attraction for symptom and travel that, arsenic needed, with cautiously selected pharmacologic therapies and dainty concurrent conductions, including anxiousness and depression," Dhruva said.
The survey was published online November 28 successful JAMA Neurology.
Commonly Used
"We cognize that SCSs are progressively commonly utilized successful objective signifier and person adjacent been suggested arsenic a device-based alternate to opioids for patients with chronic pain," Dhruva said.
"However, the existent grounds basal for SCSs includes chiefly tiny studies, and determination are fewer independent, large, real-world evaluations; and thus, we aimed to behaviour 1 of the astir rigorous studies imaginable extracurricular of a prospective randomized, double-blind, placebo procedure–controlled trial."
The researchers turned to longitudinal aesculapian and pharmacy claims from Medicare Advantage enrollees drawn from Optum Labs Data Warehouse (February 1, 2021, to August 31, 2022).
They included successful their survey patients (n = 7560; mean [SD] age, 63.5 [12.5] years; 40.7% men; 59.3% women; 77.9% White; 11.9% Black; 6.4% Hispanic; and 0.7% Asian) with incidental diagnosis codes for failed backmost country syndrome, complex determination symptom syndrome, chronic symptom syndrome, and different chronic postsurgical backmost and extremity pain.
The survey utilized a 1:5 propensity-matched retrospective plan (n = 1260 successful the SCS cohort and 6300 successful the CMM cohort). SCS patients had to person received a permanent, alternatively than a trial, implant. CMM consisted of symptom medications, spine surgery, radiofrequency ablation, epidural and facet corticosteroid injections, and blimpish nonpharmacologic therapies (physical therapy, chiropractic, and acupuncture).
Long-term opioid usage and epidural and facet corticosteroid injection usage from 1–12 and 13–24 months aft the scale day (primary outcomes) were "surrogates" for superior semipermanent symptom attraction modalities.
Other outcomes included medications and treatments (long-acting opioid use; radiofrequency ablations; caller spine surgeries; and filling prescriptions for nonsteroidal anti-inflammatory drugs, systemic corticosteroids, antidepressants, gabapentinoids, and benzodiazepines); healthcare utilization, full costs of care, postprocedural complications; and SCS removal and revision.
Efficacy "Overestimated"
At baseline, 79% of the patients who were treated with SCS besides received opioids, and 15.4% were receiving rehabilitative therapies.
During the archetypal year, patients treated with SCSs had higher likelihood of semipermanent opioid usage but little likelihood of utilizing different procedures and medications. During the 2nd year, determination was nary quality betwixt the groups successful semipermanent opioid usage oregon utilization of different procedures and medications.
Table. Adjusted Odds Ratios for SCS vs CMM (95% CI)
| Long-term opioid use | 1.14 (1.01 – 1.29) | 1.06 (0 .94 – 1.20) |
| Epidural/facet corticosteroid injections | 0.44 (0.39 – 0.51) | 1.00 (0.87 – 1.14) |
| Radiofrequency ablation | 0.57 (0.44 – 0.72) | 0.84 (0.66 – 1.09) |
| Spine surgery | 0.72 (0.61 – 0.85 | 0.91 (0.75 – 1.09) |
Of the patients treated with SCS, 17.9% experienced SCS-related complications (including breakdown, displacement, different mechanical complications, and corruption of the pb and/or generator) wrong 2 years; 22.1% underwent instrumentality revisions and/or removal, and of these, 1 tenth of cases were not associated with a complication, "suggesting a deficiency of effectiveness," the authors write.
Total costs of attraction successful the archetypal twelvemonth were $39,000 higher with SCS than with CMM, though costs were akin betwixt the modalities successful the 2nd year.
"I deliberation that our findings suggest SCSs are not effectual astatine reducing symptom astatine a capable level that patients trim usage of opioids," Dhruva commented. "This could beryllium related to the information that the objective trials for SCS — erstwhile they person been conducted — person precise infrequently utilized a placebo procedure, and thus, efficacy is apt to beryllium overestimated."
"Multiple Issues"
Commenting for Medscape Medical News, Joshua M. Rosenow, MD, director of functional neurosurgery and prof of neurosurgery, neurology, and carnal medicine and rehabilitation, Northwestern Medicine, Chicago, Illinois, said that the survey has "multiple issues."
"It is mostly accepted that SCS therapy increases healthcare costs successful the abbreviated word owed to the outgo of country and the instrumentality itself." But different studies person "shown that outgo neutrality typically takes astir 2.5 years to achieve, truthful by stopping abbreviated of that clip point, it is not astonishing that SCS patients had higher healthcare costs," said Rosenow, who was not progressive successful the research.
Multiple peer-reviewed studies person shown that patients who successfully acquisition SCS "are wide capable to importantly alteration their opioid use," and successful this study, a person look astatine the information "shows that successful the archetypal year, the SCS patients were much apt to beryllium utilizing high-dose opioids but were nary much apt to beryllium utilizing high-dose opioids successful the 2nd year...contradicting the dire decision of the survey that SCS has nary effect connected opioid use."
In addition, the survey "has insufficient item to recognize for what symptom information these individuals were utilizing opioids.... Likewise, we bash not cognize if the interventional symptom procedures and spinal country these radical received were for the aforesaid symptom denotation arsenic the SCS was targeting," Rosenow added.
Furthermore, helium noted that the survey "does not see functional outcomes.... What this survey cannot amusement america is whether the radical who received SCS were much functional with the instrumentality arsenic 1 constituent of their symptom treatment."
SCS "has decades of peer-reviewed grounds attesting to its effectiveness successful reducing symptom and improving relation crossed aggregate chronic symptom syndromes," Rosenow concluded. "As leaders successful the field, it is incumbent upon america to proceed to amended those physicians utilizing this therapy connected due diligent selection, safety, due technique, and complication avoidance and management."
Dhruva has received grants from Arnold Ventures; probe backing from the Greenwall Foundation, the Department of Veterans Affairs, the National Evaluation System for Health Technology Coordinating Center, the US Food and Drug Administration, and the National Institute for Health Care Management; and has served connected the Institute for Clinical and Economic Review California Technology Assessment Forum. The different authors' applicable fiscal relationships are listed connected the archetypal article. Rosenow has consulting agreements with Boston Scientific Neuromodulation, Stryker, and AIM Medical Robotics.
JAMA Neurol. Published online November 28, 2022. Abstract
Batya Swift Yasgur, MA, LSW, is simply a freelance writer with a counseling signifier successful Teaneck, NJ. She is simply a regular contributor to galore aesculapian publications, including Medscape and WebMD, and is the writer of respective consumer-oriented wellness books arsenic good arsenic Behind the Burqa: Our Lives successful Afghanistan and How We Escaped to Freedom (the memoir of 2 brave Afghan sisters who told her their story).
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