Comparison of Paresthesia Mapping to Anatomical Placement in Burst Spinal Cord Stimulation: Initial Trial Results of the Prospective, Multicenter, Randomized, Double‐Blinded, Crossover, CRISP Study (original) (raw)
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Neuromodulation: Technology at the Neural Interface, 2021
Objectives: Spinal cord stimulation (SCS) is an effective therapy for chronic intractable pain. Conventional SCS involves electrode placement based on intraoperative paresthesia mapping; however, newer paradigms like burst may allow for anatomic placement of leads. Here, for the first time, we report the one-year safety and efficacy of burst SCS delivered using a lead placed with conventional, paresthesia mapping, or anatomic placement approach in subjects with chronic low back pain (CLBP). Materials and Methods: Subjects with CLBP were implanted with two leads. The first lead was placed to cross the T8/T9 disc and active contacts for this lead were chosen through paresthesia mapping. The second lead was placed at the T9/T10 spinal anatomic landmark. Subjects initially underwent a four-week, double-blinded, crossover trial with a two-week testing period with burst SCS delivered through each lead in a random order. At the end of trial period, subjects expressed their preference for one of the two leads. Subsequently, subjects received burst SCS with the preferred lead and were followed up at 3, 6, and 12 months. Pain intensity (visual analog scale), quality-of-life (EuroQol-5D instrument), and disability (Oswestry Disability Index) were evaluated at baseline and follow-up. Results: Forty-three subjects successfully completed the trial. Twenty-one preferred the paresthesia mapping lead and 21 preferred the anatomic placement lead. Anatomic placement lead was activated in one subject who had no preference. The pain scores (for back and leg) significantly improved from baseline for both lead placement groups at all follow-up time points, with no significant between-group differences. Conclusions: This study demonstrated that equivalent clinical benefits could be achieved with burst SCS using either paresthesia mapping or anatomic landmark-based approaches for lead placement. Nonparesthesia-based approaches, such as anatomic landmark-based lead placement investigated here, have the potential to simplify implantation of SCS and improve current surgical practice.
Neuro-Chirurgie, 2015
Multicolumn spinal cord stimulation (SCS) is now considered to be effective for the treatment of the radicular and back component in refractory Failed Back Surgery Syndrome (FBSS) patients. The relationship between the paresthesia coverage of the back and clinical outcomes has recently been confirmed by an international prospective study. However, significant disparities in outcomes were identified and could result from the heterogeneity of lead implantation parameters which are dependant on local practices and experience. We therefore sought to analyse the impact of lead implantation level and its lateralization on the ability to address back pain with multicolumn SCS leads. The present study was a retrospective subgroup analysis from an observational, prospective non-randomized trial that included 76 patients with refractory FBSS, implanted with multicolumn SCS between 2008 to 2011 in three neurosurgical pain centres (Poitiers, France, Montreal, Canada and Regina, Canada). A subgr...
2017
pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming.
Pain physician, 2017
Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming. To determine if pain relief was related to technical factors of paresthesia, we m...
Prospective study of the success and efficacy of spinal cord stimulation
Minerva anestesiologica, 2004
To explore success, the percentage of patients who received definitive implants compared to all patients screened, and efficacy, the percentage of patients that had improved in at least 3 of the 5 parameters after 1 year. In addition, we determined if there was a statistically significant reduction in pain and functional limiting. Finally, we wanted to investigate if the different paresthesia coverage has a different outcome after 1 year of SCS treatment. We studied 170 patients with neuropathic pain syndrome, failed back surgery syndrome and vascular disease, who received spinal cord stimulation (SCS) in the last 4 years. We evaluated, at the beginning and after 1 year, the patients with a questionnaire that assessed pain, what kind of function, drug consumption, patient's satisfaction and the improvement in the quality of life. This study showed a success of more than 50% and an efficacy of more than 69.9%, with no significant differences in 3 different chronic pain conditions...
Pain medicine (Malden, Mass.), 2017
BACKGROUND : The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain inte...
Percutaneous Spinal Cord Stimulation Lead Placement Under Deep Sedation and General Anesthesia
Pain and Therapy, 2021
Introduction: Spinal cord stimulation (SCS) is a commonly utilized therapy for the treatment of neuropathic pain conditions. The Neurostimulation Appropriateness Consensus Committee (NACC) has recommended that the placement of percutaneous SCS leads be performed in an awake patient capable of providing feedback. It is not currently known how commonly this recommendation is adhered to by physicians in clinical practice. This article presents the findings of a survey designed to answer this important question. Methods: We conducted a survey of the active membership of the American Society of Regional Anesthesia and Pain Medicine (ASRA) and the Spine Intervention Society (SIS) regarding practice patterns with SCS therapy. We analyzed the percent of respondents who indicated that they use deep sedation and general anesthesia during SCS placement as well as any reported complications. Results: Many practitioners frequently utilize deep sedation as well as general anesthesia when performing SCS implants. Our findings demonstrate that 77% of physicians reported that they utilize deep sedation for permanent SCS implants at times, and 45% of physicians