Spinal Cord Stimulation and Evidence-Based Medicine—Cui Bono

Abstract

Until 2010, 1 De Ridder D. Vanneste S. Plazier M. Van Der Loo E. Menovsky T. Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery. 2010; 66: 986-990 Google Scholar spinal cord stimulation (SCS) parameters elicited paresthesia, which made it impossible to conduct the blind placebo-controlled trials needed to achieve the highest level in the practice of “evidence-based medicine.” Today, however, SCS pulse generators can be programmed to provide pain relief with amplitudes below the paresthesia threshold using frequencies as high as 10 kHz and/or a “burst” waveform. None of these programs can lead to effective pain relief, however, if the amplitude is too low. In fact, in a recent three-way sham-controlled trial, Eldabe et al 2 Eldabe S. Duarte R. Gulve A. et al. Analgesic efficacy of “burst” and tonic (500 Hz) spinal cord stimulation patterns: a randomized placebo-controlled crossover study. Neuromodulation. 2021; 24: 471-478 Google Scholar reported that a burst waveform with an amplitude of 10% below the paresthesia threshold was no more effective than was placebo/sham, whereas a 500 Hz waveform was significantly more effective. This previous article renders unexceptional and predictable the results of a study by Hara et al, 3 Hara S. Andresen H. Solheim O. et al. Effect of spinal cord burst stimulation vs placebo stimulation on disability in patients with chronic radicular pain after lumbar spine surgery: a randomized clinical trial. JAMA. 2022; 328: 1506-1514 Google Scholar which was the first to report primary data on SCS in the Journal of the American Medical Association (JAMA) proper (as opposed to JAMA Neurology). After all, if 10% below perception was too low, the amplitude of 50% and 70% below the paresthesia threshold reported by Hara et al must certainly be too low. The fact that Hara et al. failed to cite the study by Eldabe et al 2 Eldabe S. Duarte R. Gulve A. et al. Analgesic efficacy of “burst” and tonic (500 Hz) spinal cord stimulation patterns: a randomized placebo-controlled crossover study. Neuromodulation. 2021; 24: 471-478 Google Scholar makes us wonder if Hara or the other authors, none of whom apparently had previously published the reports of an SCS trial, were even aware of the Eldabe et al study. Placebo (Sham) Controlled Trials of Spinal Cord StimulationNeuromodulationPreviewSpinal cord stimulation (SCS) has been in use for more than 50 years and recommended by health care payers across the globe as a clinically effective and cost-effective intervention for people with refractory chronic neuropathic pain. However, given that the evidence base for SCS has largely been industry supported and from open-label randomized controlled trials (RCTs), there remain some concerns that the efficacy and safety observed in such studies may be open to bias and not reflect routine clinical practice. Full-Text PDF Semantic Confusion Risks Undermining the Science of Spinal Cord StimulationNeuromodulationPreviewI read with interest the article published in Journal of the American Medical Association (JAMA) by Hara et al titled, “Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial.” There were no significant between-group differences for the change from baseline in Oswestry Disability Index score, or in pain scores, or in quality of life; in other words, according to this article, burst spinal cord stimulation has no effect that outperforms placebo. Full-Text PDF Randomized Trial of Spinal Cord Stimulation in Chronic Pain: A Critical ReviewNeuromodulationPreviewIn a recently published article, Hara et al1 evaluated a novel waveform of spinal sord stimulation (SCS) efficacy vs placebo in patients with persistent pain after spinal surgery. The authors compared a change from baseline in the Oswestry Disability Index (ODI) score in a series of patients with chronic radicular pain after lumbar surgery, who were screened with a conventional SCS and after implantation of an SCS system, had either placebo stimulation or “burst” stimulation delivered in a randomized order. Full-Text PDF