Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trialReport as inadecuate




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Trials

, 17:569

First Online: 01 December 2016Received: 16 May 2016Accepted: 15 November 2016DOI: 10.1186-s13063-016-1706-5

Cite this article as: Slavin, K.V., North, R.B., Deer, T.R. et al. Trials 2016 17: 569. doi:10.1186-s13063-016-1706-5

Abstract

BackgroundBurst stimulation is a novel form of neurostimulation for the treatment of chronic pain which has demonstrated promise in small uncontrolled studies, but has not yet gained approval for use in the U.S. We report the study methods for an ongoing multicenter, randomized, controlled, cross-over study designed to gain United States Food and Drug Administration FDA approval for burst stimulation.

MethodsParticipants who are candidates for a currently approved neurostimulation device were enrolled and screened. Participants who fail a tonic trial evaluation, have significant depressive symptoms, or evidence lack of compliance with study procedures by failing to complete 7 days of a Pain Diary are excluded. Participants receiving a permanent implant are randomized to receive: 1 12 weeks of tonic followed by 12 weeks of burst stimulation or 2 12 weeks of burst stimulation followed by 12 weeks of tonic stimulation. Assessments occur at 6, 12, 18, and 24 weeks. After 24 weeks, participants choose their preferred therapy and are assessed every 6 months for up to 2 years. All patients had the device leads inserted at the site of a successful tonic stimulation trial. Assessments include: a Pain Diary using a Visual Analog Scale VAS for overall, trunk, and limb pain, the Beck Depression Inventory, the Pain Catastrophizing Scale, the Oswestry Disability Index, paresthesia, satisfaction, and therapy preference. Reported adverse events are collected throughout the study. The primary endpoint is the noninferiority of burst stimulation compared to tonic measured by the within-subject difference in the mean overall VAS score at the end of each 12-week stimulation period.

DiscussionThis trial represents the largest controlled trial of burst stimulation to date, and is expected to yield important information regarding the safety and efficacy of burst stimulation.

Trial registrationClinicalTrials.gov, NCT02011893. Registered on 10 December 2013.

KeywordsNeuromodulation Spinal cord Stimulation Randomized Prospective Comparative efficacy Burst stimulation Tonic stimulation AbbreviationsAEsAdverse events

BDI-IIBeck depression inventory version II

FDAUnited States Food and Drug Administration

IDEInvestigational device exemption

IRBInstitutional review board

ODIOswestry disability index

PCSPain catastrophizing scale

PGICPatient global impression of change

SCSSpinal cord stimulation

SF-36v2Short Form 36 Health Survey version 2

SF-MPQ-2Short Form McGill Pain Questionnaire version 2

VASVisual analog scale for pain

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1706-5 contains supplementary material, which is available to authorized users.

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Author: Konstantin V. Slavin - Richard B. North - Timothy R. Deer - Peter Staats - Kristina Davis - Roni Diaz

Source: https://link.springer.com/







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