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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.

ABSTRACT: INTRODUCTION:In this prospective, multicenter, double-blinded, randomized, crossover study, we compared the therapeutic efficacy of burst SCS delivered using a lead implanted with the paresthesia mapping approach to a lead implanted with an anatomic placement approach. MATERIALS AND METHODS:Subjects with chronic low back pain were implanted with two leads, one using paresthesia-mapping approach (PM) and the second using anatomical placement procedure (AP). Stimulation contacts were chosen using the standard intraoperative paresthesia-testing procedure for the paresthesia-mapped lead or an activated bipole overlapping the T9-T10 junction for the anatomical lead. Amplitude for either lead was selected such that no sensory percepts were generated. Subjects were assessed at baseline and after a trial period during which they tested each lead for two weeks in random order. Eligible subjects had the option to receive permanent implants using their preferred AP or PM approach at end-of-trial. RESULTS:Of the 53 subjects who completed both trial periods, 43 (81.1%) experienced at least 50% back pain relief with at least one lead. Nearly half of these (20; 46.5%) were profound responders who experienced at least 80% back pain relief with either leads. Primary and secondary outcomes, at the end of trial, showed significant improvements for both AP and PM leads from baseline yet were not significantly different from each other. DISCUSSION:The trial results of this study suggest that similar clinical outcomes can be achieved in burst SCS when performing lead placement either using paresthesia mapping or anatomical placement with imaging references.

SUBMITTER: Al-Kaisy A

PROVIDER: S-EPMC7496371 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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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.

Al-Kaisy Adnan A Baranidharan Ganesan G Palmisani Stefano S Pang David D Will Onita O Wesley Samuel S Crowther Tracey T Ward Karl K Castino Paul P Raza Adil A Agnesi Filippo F

Neuromodulation : journal of the International Neuromodulation Society 20200312 5

<h4>Introduction</h4>In this prospective, multicenter, double-blinded, randomized, crossover study, we compared the therapeutic efficacy of burst SCS delivered using a lead implanted with the paresthesia mapping approach to a lead implanted with an anatomic placement approach.<h4>Materials and methods</h4>Subjects with chronic low back pain were implanted with two leads, one using paresthesia-mapping approach (PM) and the second using anatomical placement procedure (AP). Stimulation contacts wer ...[more]

PMID: 32166842

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Project description:ImportanceIndividuals with spinal cord injury (SCI) have significant autonomic nervous system dysfunction. However, despite recent findings postulated to support that spinal cord stimulation improves dynamic autonomic regulation, limited scope of previous testing means the true effects remain unknown.ObjectiveTo determine whether transcutaneous spinal cord stimulation improves dynamic autonomic regulation after SCI.DesignSingle-blinded, randomized crossover trial with matched cohorts.SettingAcademic autonomic physiology laboratory.ParticipantsTwo pairs of well-matched individuals with and without high-thoracic, complete SCI.InterventionsSub-motor threshold transcutaneous spinal cord stimulation delivered at T10-T11 using 120Hz, 30Hz, and 30Hz with 5kHz carrier frequency at separate autonomic testing sessions.Main outcomes and measuresBaseline autonomic regulation was characterized with tests of above injury level sympathoexcitation (Valsalva's maneuver), sympathoinhibition (progressive doses of bolus intravenous phenylephrine), and below level sympathoexcitation (foot cold pressor test). At three subsequent visits, this testing battery was repeated with the addition of spinal cord stimulation at each frequency. Changes in autonomic regulation for each frequency were then analyzed relative to baseline testing for each individual and within matched cohorts.ResultsUninjured controls demonstrated no autonomic deficits at baseline and had no changes with any frequency of stimulation. Contrasting this, and as expected, individuals with SCI had baseline autonomic dysfunction. In a frequency-dependent manner, spinal cord stimulation enhanced sympathoexcitatory responses, normalizing previously impaired Valsalva's maneuvers. However, stimulation exacerbated already impaired sympathoinhibitory responses, resulting in significantly greater mean arterial pressure increases with the same phenylephrine doses compared to baseline. Impaired sympathoexcitatory response below the level of injury were also further exacerbated with spinal cord stimulation. At baseline, neither individual with SCI demonstrated autonomic dysreflexia with the noxious foot cold pressor test; the addition of stimulation led to a dysreflexic response in every trial, with greater relative hypertension and bradycardia indicating no improvement in autonomic regulation.Conclusions and relevanceTranscutaneous spinal cord stimulation does not improve autonomic regulation after SCI, and instead likely generates tonic, frequency-dependent sympathoexcitation which may lower the threshold for autonomic dysreflexia.

Project description:To assess the clinical and anatomical causes of cutaneous paresthesia after internal fixation of clavicle fractures.This study included 135 patients who underwent internal fixation of clavicle fractures from May 2013 to June 2016 at the First and Second Affiliated Hospital of Guangxi Medical University. The incidence of postoperative supraclavicular nerve injury, the duration of numbness, and improvements after plate removal were retrospectively analyzed. Seven human cadaver specimens were subsequently dissected to analyze the supraclavicular nerve and its relationship to numbness.Of the 135 patients who underwent internal fixation of clavicle fractures, 26 (19.3%) experienced postoperative cutaneous paresthesia, with 22 (16.3%) and 4 (2.8%) experiencing numbness and pain, respectively. The most intense numbness occurred during the first operative month. Of the 22 patients with numbness, 1 (4.5%), 1 (4.5%), and 20 (90.1%) patients reported mild, moderate, and severe numbness, respectively. Two patients described increased awareness of numbness when in contact with clothes, 2 were psychologically affected by numbness, and 20 (90.1%) reported reduced severity of numbness over time. At the last follow-up, numbness was found to persist in 2 (1.5%) patients. None of the patients was bothered by numbness. Cadaver dissection showed that the supraclavicular nerve emerged from the 1/2 posterior edge of the cervical sternocleidomastoid muscle and subsequently divided into 3 branches, with the lateral branch 2.26 ± 1.17 cm from the lateral margin of the acromion, the middle branch near the mid-clavicle, and the medial branch 2.03 ± 0.85 cm from the sternal lateral margin.Cutaneous paresthesia is common following internal fixation of the clavicle. Anatomic analysis showed that the nerve could be easily injured during clavicle operation. Numbness improved in most patients, but persisted for up to 2 years and was even permanent in a few. Most patients considered numbness as an insignificant factor in their daily lives.

Dataset Information

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.

Publications

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.

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