Clinical Effectiveness and Mechanism of Action of Spinal Cord Stimulation for Treating Chronic Low Back and Lower Extremity Pain: a Systematic Review

Vallejo, Ricardo; Gupta, Ashim; Cedeño, David L.; Vallejo, Alejandro; Smith, William J.; Thomas, Samuel M.; Benyamin, Ramsin; Kaye, Alan D.; Manchikanti, Laxmaiah

doi:10.1007/s11916-020-00907-2

Cited by 31 publications

(22 citation statements)

References 73 publications

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“…The Senza SCS system has already been approved by the FDA in the management of chronic intractable pain of the trunk or limbs associated with failed back surgery syndrome or intractable low back or leg pain. Prior systematic reviews support the use of any SCS in this particular indication; however, they have also found evidence suggesting that 10 kHz SCS devices demonstrate more favorable outcomes relative to traditional devices [41][42][43][44][45][46]. More specifically, the reviews by Vallejo et al and Conger et al found similar values for the percentage of patients who experienced C 50% reduction in pain following 10 kHz SCS as estimated in the current meta-analysis on those with upper limb or neck pain (i.e., 83% [95% CI 77-89%]) [41,46].…”

Section: Efficacy Of Cervical 10 Khz Scsmentioning

confidence: 99%

“…Prior systematic reviews support the use of any SCS in this particular indication; however, they have also found evidence suggesting that 10 kHz SCS devices demonstrate more favorable outcomes relative to traditional devices [41][42][43][44][45][46]. More specifically, the reviews by Vallejo et al and Conger et al found similar values for the percentage of patients who experienced C 50% reduction in pain following 10 kHz SCS as estimated in the current meta-analysis on those with upper limb or neck pain (i.e., 83% [95% CI 77-89%]) [41,46]. In terms of pain medication consumption, Pollard et al found that 10 kHz SCS resulted in increased odds of reducing opioid use and greater mean medication dose reduction compared to traditional SCS in patients with intractable spine and limb pain, though there was limited evidence and the results were not statistically significant [45].…”

Section: Efficacy Of Cervical 10 Khz Scsmentioning

confidence: 99%

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Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

et al. 2021

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Background: Chronic pain in head, neck, shoulders and upper limbs is debilitating, and patients usually rely on pain medications or surgery to manage their symptoms. However, given the current opioid epidemic, non-pharmacological interventions that reduce pain, such as spinal cord stimulation (SCS), are needed. The purpose of this study was to review the evidence on paresthesia-free 10 kHz SCS therapy for neck and upper extremity pain.Methods: Systematic literature search was performed for studies reporting outcomes for cervical 10 kHz SCS using date limits from May 2008 to November 2020. The study results were analyzed and described qualitatively. Additionally, when feasible, meta-analyses of the outcome data, with 95% confidence intervals (CIs), were conducted using both the fixed-effects (FE) and random-effects (RE) models. Results: A total of 15 studies were eligible for inclusion. The proportion of patients who achieved C 50% pain reduction was 83% (95% CI 77-89%) in both the FE and RE models. The proportion of patients who reduced/eliminated their opioid consumption was 39% (95% CI 31-46%) in the FE model and 39% (95% CI 31-48%) in the RE model. Pain or discomfort with the implant, lead migration, and infections were potential risks following cervical SCS. Explant rate was 0.1 (95% CI 0.0-0.2) events per 100 person-months, and no patients in the included studies experienced a neurological complication or paresthesia. Conclusion: Findings suggest 10 kHz SCS is a promising, safe, minimally invasive alternative for managing chronic upper limb and neck pain.

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Section: Efficacy Of Cervical 10 Khz Scsmentioning

confidence: 99%

Section: Efficacy Of Cervical 10 Khz Scsmentioning

confidence: 99%

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

et al. 2021

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“…The complexity of changes in neuron-glial biological processes triggered by pain and further modulation by electrical stimulation demands the use of experimental animal models. Testing such hypotheses in humans would require large-scale, wellcontrolled clinical trials because of the heterogeneity of genetics and pain etiology in the general population [9].…”

Section: Introductionmentioning

confidence: 99%

Animal Pain Models for Spinal Cord Stimulation

Williams¹,

Kelley²,

Vallejo³

et al. 2022

Preclinical Animal Modeling in Medicine

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Spinal cord stimulation (SCS) is an electrical neuromodulation technique with proven effectiveness and safety for the treatment of intractable chronic pain in humans. Despite its widespread use, the mechanism of action is not fully understood. Animal models of chronic pain, particularly rodent-based, have been adapted to study the effect of SCS on pain-like behavior, as well as on the electrophysiology and molecular biology of neural tissues. This chapter reviews animal pain models for SCS, emphasizing on findings relevant to advancing our understanding of the mechanism of action of SCS, and highlighting the contribution of the animal model to advance clinical outcomes. The models described include those in which SCS has been coupled to neuropathic pain models in rats and sheep based on peripheral nerve injuries, including the chronic constriction injury (CCI) model and the spared nerve injury model (SNI). Other neuropathic pain models described are the spinal nerve ligation (SNL) for neuropathic pain of segmental origin, as well as the chemotherapy-induced and diabetes-induced peripheral neuropathy models. We also describe the use of SCS with inflammatory pain and ischemic pain models.

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“…SCS is a well-known treatment option for patients with Failed Back Surgery Syndrome (FBSS) who are refractory to conventional management, with positive effects on the pain experience and quality of life [1][2][3][4][5]. The exact mechanisms of SCS are not yet fully elucidated; however, several working mechanisms and hypotheses have been proposed on spinal, segmental and supraspinal level [6,7]. Additionally, during the latest years it is assumed that SCS induces alterations in the autonomic nervous system with an upregulation of the parasympathetic system, based on heart rate variability, respiration, and skin conductance measurements [8,9].…”

Section: Introductionmentioning

confidence: 99%

Exhaled-Breath Testing Using an Electronic Nose during Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: An Experimental Pilot Study

Goudman¹,

Jansen

Vets

et al. 2021

JCM

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The increased awareness of discrepancies between self-reporting outcome measurements and objective outcome measurements within the field of neuromodulation has accelerated the search towards more objective measurements. The aim of this study was to evaluate whether an electronic nose can differentiate between chronic pain patients in whom Spinal Cord Stimulation (SCS) was activated versus deactivated. Twenty-seven patients with Failed Back Surgery Syndrome (FBSS) participated in this prospective pilot study. Volatile organic compounds in exhaled breath were measured with electronic nose technology (AeonoseTM) during SCS on and off states. Random forest was used with a leave-10%-out cross-validation method to determine accuracy of discriminating between SCS on and off states. Our random forest showed an accuracy of 0.56, with an area under the curve of 0.62, a sensitivity of 62% (95% CI: 41–79%) and a specificity of 50% (95% CI: 30–70%). Pain intensity scores were significantly different between both SCS states. Our findings indicate that we cannot discriminate between SCS off and on states based on exhaled breath with the AeonoseTM in patients with FBSS. In clinical practice, these findings imply that with a noninvasive electronic nose, exhaled breath cannot be used as an additional marker of the effect of neuromodulation.

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Clinical Effectiveness and Mechanism of Action of Spinal Cord Stimulation for Treating Chronic Low Back and Lower Extremity Pain: a Systematic Review

Cited by 31 publications

References 73 publications

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis

Animal Pain Models for Spinal Cord Stimulation

Exhaled-Breath Testing Using an Electronic Nose during Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome: An Experimental Pilot Study

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