A Prospective, Randomised, Double-blind, Placebo-controlled Study to Examine the Effectiveness of Burst Spinal Cord Stimulation Patterns for the Treatment of Failed Back Surgery Syndrome

Schu, Stefan; Slotty, Philipp J.; Bara, Gregor; Knop, Monika von; Edgar, Deborah; Vesper, Jan

doi:10.1111/ner.12197

Cited by 184 publications

(192 citation statements)

References 27 publications

(25 reference statements)

Supporting

Mentioning

167

Contrasting

Unclassified

Order By: Relevance

“…motivational/affective/emotional component of the pain in contrast to traditional tonic waveforms [16]. The fact that both new stimulation designs can suppress pain better than classical tonic stimulation [14][15][16][17][18][22][23][24][25] opens up an avenue for even more new stimulation designs to be developed. Changing IPGs for trying to improve patient outcomes will lead to more surgery, with surgical and infectious risks and a financial heavy burden on society.…”

Section: Is There a Problem?mentioning

confidence: 99%

Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Ridder

Vanneste

2016

Expert Review of Medical Devices

View full text Add to dashboard Cite

Recently burst stimulation and 10 kHz stimulation have been developed as novel stimulation designs. Both appear to be superior to classical tonic stimulation in the amount of responders and the amount of pain suppression and have as an extra advantage that they are paresthesia-free. This evolution is very important as it shifts the focus of research from better targeting by developing new lead configurations to better communication with the nervous system. It can be envisioned that this is only the start of a new trend in spinal cord, brain, and peripheral nerve stimulation and that more new stimulation designs will be developed in the near future such as pseudorandom burst stimulation, pleasure stimulation, noise stimulation and reconditioning stimulation. This evolution mandates a new approach in the development of internal pulse generators, and the most obvious approach is to develop an upgradable stimulator, on which new stimulation designs can be downloaded, analogous to the apps people download on their smartphones. This will create a shift from hardware driven products to software driven stimulators.

show abstract

Section: Is There a Problem?mentioning

confidence: 99%

Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Ridder

Vanneste

2016

Expert Review of Medical Devices

View full text Add to dashboard Cite

show abstract

“…The only exceptions are Perruchoud et al, 29 who reported no differences in patient satisfaction between 5-kHz versus conventional stimulation parameters (40-to 50-Hz paresthesiabased stimulation), and Schu et al, 30 who did not report a comparison between groups, but rather an 80% patient satisfaction rate with burst stimulation. Each of the other studies reported significant differences (Table 3).…”

Section: Patient Satisfaction With Scs Therapymentioning

confidence: 99%

“…24,[26][27][28][29][30][31] Outcomes-specific data are reported in Table 3. The earliest study, by North et al, 24 in 2005, compared SCS with repeated lumbosacral spine surgery for FBSS patients, which yielded a difference of 35.8% (P < 0.01) in the primary outcome (≥50% pain relief ) favoring the SCS group at 3 years' follow-up, albeit with a small sample size in a single center.…”

Section: Perceived Pain Relief or Change In Pain Scorementioning

confidence: 99%

“…[28][29][30] Schultz et al 28 found no statistical difference in NRS pain scores between groups when comparing Medtronic RestoreSensor position-adaptive neurostimulation with manual programming in the same system. Perruchoud et al 29 compared Medtronic SCS systems that varied by frequency of stimulation (5 kHz, conventional 40-50 Hz, and sham stimulation) and found no statistically significant differences in VAS pain scores.…”

Section: Perceived Pain Relief or Change In Pain Scorementioning

confidence: 99%

“…Perruchoud et al 29 compared Medtronic SCS systems that varied by frequency of stimulation (5 kHz, conventional 40-50 Hz, and sham stimulation) and found no statistically significant differences in VAS pain scores. Schu et al, 30 on the other hand, found that burst stimulation (packets of 5 pulses [1 millisecond each] at 500 Hz, delivered 40 times per second; St Jude Medical) resulted in a mean decrease in NRS pain score of 2.4 and 3.6 compared with tonic 500-Hz stimulation and to placebo (sham) stimulation, respectively (P < 0.05).…”

Section: Perceived Pain Relief or Change In Pain Scorementioning

confidence: 99%

See 2 more Smart Citations

Spinal Cord Stimulation 50 Years Later

Mekhail

Visnjevac

Azer

et al. 2018

Regional Anesthesia and Pain Medicine

View full text Add to dashboard Cite

To assess the efficacy of spinal cord stimulation (SCS) for each indication, one must critically assess each specific clinical outcome to identify outcomes that benefit from SCS therapy. To date, a comprehensive review of clinically relevant outcome-specific evidence regarding SCS has not been published. We aimed to assess all randomized controlled trials from the world literature for the purpose of evaluating the clinical outcome-specific efficacy of SCS for the following outcomes: perceived pain relief or change pain score, quality of life, functional status, psychological impact, analgesic medication utilization, patient satisfaction, and health care cost and utilization. Interventions were SCS, without limitation to the type of controls or the type of SCS in the active arms. For each study analyzed, a quality assessment was performed using a validated scale that assesses reporting, external validity, bias, confounding, and power. Each outcome was assessed specific to its indication, and the primary measure of each abovementioned outcome was a summary of the level of evidence. Twenty-one randomized controlled trials were analyzed (7 for trunk and limb pain, inclusive of failed back surgery syndrome; 8 for refractory angina pectoris; 1 for cardiac X syndrome; 3 for critical limb ischemia; 2 for complex regional pain syndrome; and 2 for painful diabetic neuropathy). Evidence assessments for each outcome for each indication were depicted in tabular format. Outcome-specific evidence scores were established for each of the abovementioned indications, providing both physicians and patients with a summary of evidence to assist in choosing the optimal evidence-based intervention. The evidence presented herein has broad applicability as it encompasses a breadth of patient populations, variations of SCS therapy, and comparable controls that, together, reflect comprehensive clinical decision making.

show abstract

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery

Hara

Andresen

Solheim

et al. 2022

JAMA

View full text Add to dashboard Cite

ImportanceThe use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking.ObjectiveTo investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.Design, Setting, and ParticipantsThis placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022.InterventionsPatients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold.Main Outcomes and MeasuresThe primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events.ResultsAmong 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were −10.6 points for the burst stimulation periods and −9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of −1.3 points (95% CI, −3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system.Conclusions and RelevanceAmong patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain–related disability.Trial RegistrationClinicalTrials.gov Identifier: NCT03546738

show abstract

A Prospective, Randomised, Double-blind, Placebo-controlled Study to Examine the Effectiveness of Burst Spinal Cord Stimulation Patterns for the Treatment of Failed Back Surgery Syndrome

Cited by 184 publications

References 27 publications

Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Spinal Cord Stimulation 50 Years Later

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery

Contact Info

Product

Resources

About