Analgesic Efficacy of “Burst” and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study

Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial

“…Parallel and crossover RCTs have previously reported no differences in effectiveness when comparing different paresthesia-free frequencies, 43 high frequency (10 kHz) vs paresthesia-inducing stimulation, 44 high frequency (5 kHz) vs placebo, 45 and burst vs different frequencies (ie, 40, 500, and 1200 Hz). 46 However, superior pain reduction has been observed for tonic subthreshold stimulation at 500 Hz vs burst or placebo, 47 high frequency (10 kHz) vs paresthesia-inducing stimulation, 17 burst vs tonic stimulation, 16 or 5882 Hz vs 1200 Hz, 3030 Hz, and sham. 48 Not only different study settings and population characteristics, but also program settings, number of leads, and electrode contacts, or how sham stimulation was enabled may all contribute to the discrepancy in the results Methodological and reporting in trials of SCS have been previously highlighted.…”

Issues in design, conduct, and conclusions of JAMA's Hara et al.'s randomized clinical trial of spinal cord burst stimulation versus placebo stimulation on disability in patients with chronic radicular pain after lumbar spine surgery

“…Having published methodological guidance for the conduct and reporting of sham‐controlled neuromodulation trials, we applaud the authors for conducting this study 2 . However, importantly, our recent 3‐arm sham controlled SCS study (sham vs four spike burst (BST) versus tonic subthreshold stimulation at 500 Hz (T500)) had a similar finding but different conclusions to those of Hara et al Although there was no difference in mean pain reduction for BST versus sham (5%; 95% CI, −13% to 27%; p = 0.59), T500 had a greater pain reduction than both sham (25%; 95% CI, 8%–38%; p = 0.008) or BST (28%; 95% CI, 13%–41%; p = 0.002) 3 …”

“…2 However, importantly, our recent 3-arm sham controlled SCS study (sham vs four spike burst (BST) versus tonic subthreshold stimulation at 500 Hz (T500)) had a similar finding but different conclusions to those of Hara et al Although there was no difference in mean pain reduction for BST versus sham (5%; 95% CI, −13% to 27%; p = 0.59), T500 had a greater pain reduction than both sham (25%; 95% CI, 8%-38%; p = 0.008) or BST (28%; 95% CI, 13%-41%; p = 0.002). 3 In this editorial, we note several issues in design, conduct, and conclusions of the Hara et al trial that make the authors' conclusion of no effect of SCS compared to sham an unsafe one.…”

“…The choice of the SCS waveform is unusual since the authors, according to their own protocol, intended to use a five‐spike burst also known as BurstDR but eventually applied a four‐spike burst without providing a rationale for this change from the protocol. This form of burst stimulation had already been tested and found to be equivalent to sham stimulation at 90% of the perception threshold, 3 yet the authors choose to retest the same mode at 50%–70% of perception threshold. Having learned in 2021 that four spike burst SCS was equivalent to sham were the authors ethically justified in continuing their experiment?…”

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

“…First, the article stated that both the participants and institutional review board were informed that spinal cord stimulation within the standard of care was to be used, and participants crossed over to sham every 3 months. Even though spinal cord stimulation has been validated in peer-reviewed publications, this study instead implemented a different type of spinal cord burst stimulation using parameters shown to be no better than placebo, which suggests that this trial compared a placebo vs another placebo. Were the participants and institutional review board informed that this trial would use a form of spinal cord stimulation lacking prior published efficacy data?…”