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01-08-2021 | Neuropathic Pain | Original Article

Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol

Authors: Adnan Al-Kaisy, Girish Vajramani, Sarah Love-Jones, Nikunj K. Patel, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Hyun-Joo Park, Adil Raza, Filippo Agnesi

Published in: Neurological Sciences | Issue 8/2021

Abstract

Background

Spinal cord stimulation (SCS) is an established therapy for chronic neuropathic pain and most frequently utilised for Failed Back Surgery Syndrome (FBSS). BurstDR™ also known as DeRidder Burst-SCS, a novel waveform, has demonstrated superiority to conventional tonic stimulation of the thoracic spine in FBSS. There are case reports of an improvement in multidimensional pain outcomes using DeRidder Burst-SCS in the cervical spine for chronic neck and cervical radicular pain. The safety and efficacy of cervical DeRidder Burst-SCS stimulation still however remain undetermined.

Methods/design

This is a prospective, multicentre feasibility trial evaluating the safety and therapeutic efficacy of DeRidder Burst-SCS stimulation for the treatment of chronic intractable neck pain with or without radiation to the arm, shoulder, and upper back. After baseline evaluation, subjects will undergo an SCS trial using the Abbott Invisible Trial system according to standard clinical procedures. During the trial phase, SCS leads will be implanted in the cervical epidural space. At the end of the SCS trial, subjects experiencing at least 50% pain relief will be considered for permanent implant. Pain intensity, medication usage, and other multidimensional pain outcomes will be collected. The timing of these will be at baseline, end of the SCS trial and at 3-, 6-, and 12-month visits. Incidence of adverse events will be collected throughout the study duration.

Discussion

The results of this feasibility study will validate the efficacy and safety of DeRidder Burst-SCS stimulation in the cervical spine. The results obtained in this study will potentially be used to generate a level 1 evidence-based study with formal statistical hypotheses testing.

Trial registration

www.clinicaltrials.gov Identifier: NCT03159169.

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Title: Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol
Authors: Adnan Al-Kaisy
Girish Vajramani
Sarah Love-Jones
Nikunj K. Patel
Jonathan Royds
Stefano Palmisani
David Pang
Samuel Wesley
Hyun-Joo Park
Adil Raza
Filippo Agnesi
Publication date: 01-08-2021
Publisher: Springer International Publishing
Keywords: Neuropathic Pain
Spinal Cord Stimulation
Neck Pain
Nerve Stimulation
Published in: Neurological Sciences / Issue 8/2021
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-020-04907-3

At a glance: The STEP trials

Springer Medicine

Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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