Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective, Multicenter, Randomized, Double-Blind, Crossover CRISP Study

Al‐Kaisy, Adnan; Baranidharan, Ganesan; Sharon, Haggai; Palmisani, Stefano; Pang, David; Will, Onita; Wesley, Samuel; Crowther, Tracey; Ward, Karl; Castino, Paul; Raza, Adil; Pathak, Yagna; Agnesi, Filippo; Yearwood, Thomas

doi:10.1111/ner.13467

Cited by 11 publications

(18 citation statements)

References 20 publications

(33 reference statements)

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“…Stimulation settings consisted of: 40 Hz interburst frequency, 500 Hz intraburst frequency of five spikes, 1 ms pulse width, 1.3–0.6 mA and cycling of 30 s on, 90 s off or continuous. Patients who did not achieve ≥50% reduction on NRS during the trial phase were offered a salvage treatment in the form of second trial consisting of L2 DRG stimulation, as previous research has shown this to be an effective treatment for CD‐LBP 20 …”

Section: Methodsmentioning

confidence: 99%

“…The implantation was performed according to anatomical placement as previously described. 18,19 Briefly, the tip of the left lead was positioned at thoracic level 8 (Th8) and the tip of the right lead was placed at Th9 without intraoperative testing. During this trial phase, an external stimulation device was programmed to provide BurstDR™ stimulation.…”

Section: Inclusion Criteriamentioning

confidence: 99%

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A prospective study of BurstDR™ spinal cord stimulation for non‐operated discogenic low back pain

et al. 2022

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Introduction Chronic discogenic low back pain (CD‐LBP) is caused by degeneration of the disc due to trauma to the annulus or by unprovoked degeneration, resulting in chronic pain. Spinal cord stimulation (SCS) employing the BurstDR™ waveform has been shown to be an effective treatment in a variety of chronic pain conditions. The aim of this prospective case study was to determine the effect of BurstDR™ SCS on pain relief, disability, and patient satisfaction in a population with CD‐LBP. Methods Seventeen subjects with CD‐LBP received a SCS trial with BurstDR™ stimulation. Patients with >50% pain relief after a trial period of 2 weeks were permanently implanted (n = 15). Patients then rated LBP and leg pain using the numeric rating scale (NRS), Oswestry disability index (ODI), patient global impression of change (PGIC), EQ‐5D quality of life, and painDETECT for neuropathic pain at baseline following trial, 3, 6, and 12 months after permanent implantation. Results Treatment with BurstDR™ SCS resulted in significant reduction of LBP as the NRS was reduced from 71.7 ± 7.3 at baseline to 42.5 ± 18.1 at 12 months. Average pain relief at 12 months was 42.5%. In patients with leg pain (n = 8), pain was significantly reduced from 66.9 ± 8.2 to 11.7 ± 10.4 at 12 months. PainDETECT scores for neuropathic pain significantly reduced from 18.9 ± 4.8 at baseline, and 14.8 ± 3.2 at 12 months. Baseline ODI score significantly reduced from 41.2 ± 12.8 to 25.8 ± 8.6 at 12 months. PGIC scores remained low from 2.6 ± 1.6 at 3 months, 2.5 ± 1.0 at 6 months, and 2.5 ± 1.3 at 12 months. EQ‐5D‐5L rates remained constant from baseline 56.10 ± 23.9 to 68.6 ± 12.9 at 12 months. Conclusion BurstDR™ SCS resulted in significant reduction of back pain, leg pain, and quality of life in patients with CD‐LBP and decreased the level of disability and generated positive patient satisfaction scores.

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Section: Methodsmentioning

confidence: 99%

Section: Inclusion Criteriamentioning

confidence: 99%

A prospective study of BurstDR™ spinal cord stimulation for non‐operated discogenic low back pain

et al. 2022

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“…Ten studies 40 55 63 69 73 for the SF-36 scores at 6 months. All secondary outcomes are presented in online supplemental figures S7-S10.…”

Section: Primary Outcomementioning

confidence: 99%

“…74 Thirteen studies were conducted in multiple centers.41-43 46 51 55 56 61 63 68 69 72-74 Eight studies were conducted in multiple countries 41. 43 52 55 5663 69 72 Most studies (22/36) were funded by industry 40. 41 43 44 46 47 49 51 53 55 56 58 59 61 63 64 6869 71-74 Seven studies had participants undergoing high-frequency SCS,41 44 50 53 59 61 72 …”

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confidence: 99%

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis

ElSaban

Kleppel

Kubrova

et al. 2023

Reg Anesth Pain Med

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BackgroundSpinal cord stimulation (SCS) has emerged as an important treatment for chronic pain disorders. While there is evidence supporting improvement in pain intensity with SCS therapy, efforts to synthesize the evidence on physical functioning are lacking.ObjectiveThe primary objective of this meta-analysis was to assess long-term physical function following 12 months of SCS for chronic back pain.Evidence reviewPubMed, EMBASE, Scopus, and CENTRAL databases were searched for original peer-reviewed publications investigating physical function following SCS. The primary outcome was physical function at 12 months following SCS therapy for chronic back pain compared with baseline. A random effects model with an inverse variable method was used. The Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) framework was used to determine the certainty of evidence.FindingsA total of 518 studies were screened, of which 36 were included. Twenty-two studies were pooled in the meta-analysis. There was a significant reduction in Oswestry Disability Index (ODI) scores at all time frames up to 24 months following implantation. Pooled results revealed significant improvement in ODI scores at 12 months with a mean difference of −17.00% (95% CI −23.07 to −10.94, p<0.001). There was a very low certainty of evidence in this finding as per the GRADE framework. There was no significant difference in subgroup analyses based on study design (randomised controlled trials (RCTs) vs non-RCTs), study funding, or stimulation type.ConclusionThis meta-analysis highlights significant improvements in physical function after SCS therapy. However, this finding was limited by a very low GRADE certainty of evidence and high heterogeneity.

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“…Several approaches have been developed to optimize the electrode placement and stimulation parameter selection of EES with the goal of reducing variation in and increasing therapeutic effectiveness of EES. These range from the classical mapping of paresthesia during trial stimulation (Al-Kaisy et al 2022 ) to recently introduced closed-loop control based on motion/position sensors and/or evoked compound action potential (ECAP) sensing following stimulation (Mekhail et al 2022 ). ECAP components in ESR are produced by the synchronous activation of multiple neuronal fibers in the dorsal column of the spinal cord (He et al 2017 ).…”

Section: Introductionmentioning

confidence: 99%

Characterization and applications of evoked responses during epidural electrical stimulation

et al. 2023

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Background Epidural electrical stimulation (EES) of the spinal cord has been FDA approved and used therapeutically for decades. However, there is still not a clear understanding of the local neural substrates and consequently the mechanism of action responsible for the therapeutic effects. Method Epidural spinal recordings (ESR) are collected from the electrodes placed in the epidural space. ESR contains multi-modality signal components such as the evoked neural response (due to tonic or BurstDR™ waveforms), evoked muscle response, stimulation artifact, and cardiac response. The tonic stimulation evoked compound action potential (ECAP) is one of the components in ESR and has been proposed recently to measure the accumulative local potentials from large populations of neuronal fibers during EES. Result Here, we first review and investigate the referencing strategies, as they apply to ECAP component in ESR in the domestic swine animal model. We then examine how ECAP component can be used to sense lead migration, an adverse outcome following lead placement that can reduce therapeutic efficacy. Lastly, we show and isolate concurrent activation of local back and leg muscles during EES, demonstrating that the ESR obtained from the recording contacts contain both ECAP and EMG components. Conclusion These findings may further guide the implementation of recording and reference contacts in an implantable EES system and provide preliminary evidence for the utility of ECAP component in ESR to detect lead migration. We expect these results to facilitate future development of EES methodology and implementation of use of different components in ESR to improve EES therapy.

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Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective, Multicenter, Randomized, Double-Blind, Crossover CRISP Study

Cited by 11 publications

References 20 publications

A prospective study of BurstDR™ spinal cord stimulation for non‐operated discogenic low back pain

A prospective study of BurstDR™ spinal cord stimulation for non‐operated discogenic low back pain

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis

Characterization and applications of evoked responses during epidural electrical stimulation

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