Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol.
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| Title: | Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. |
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| Authors: | Al-Kaisy, Adnan (AUTHOR), Vajramani, Girish (AUTHOR), Love-Jones, Sarah (AUTHOR), Patel, Nikunj K. (AUTHOR), Royds, Jonathan (AUTHOR), Palmisani, Stefano (AUTHOR), Pang, David (AUTHOR), Wesley, Samuel (AUTHOR), Park, Hyun-Joo (AUTHOR), Raza, Adil (AUTHOR), Agnesi, Filippo (AUTHOR) |
| Source: | Neurological Sciences. Aug2021, Vol. 42 Issue 8, p3285-3296. 12p. 3 Diagrams, 1 Chart. |
| Subjects: | Neck pain, Spinal cord, Failed back surgery syndrome, Statistical hypothesis testing, Epidural space, Neuralgia |
| 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 151760090 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Al-Kaisy%2C+Adnan%22">Al-Kaisy, Adnan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vajramani%2C+Girish%22">Vajramani, Girish</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Love-Jones%2C+Sarah%22">Love-Jones, Sarah</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Patel%2C+Nikunj+K%2E%22">Patel, Nikunj K.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Royds%2C+Jonathan%22">Royds, Jonathan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Palmisani%2C+Stefano%22">Palmisani, Stefano</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pang%2C+David%22">Pang, David</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wesley%2C+Samuel%22">Wesley, Samuel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Park%2C+Hyun-Joo%22">Park, Hyun-Joo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Raza%2C+Adil%22">Raza, Adil</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Agnesi%2C+Filippo%22">Agnesi, Filippo</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Neurological+Sciences%22">Neurological Sciences</searchLink>. Aug2021, Vol. 42 Issue 8, p3285-3296. 12p. 3 Diagrams, 1 Chart. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Neck+pain%22">Neck pain</searchLink><br /><searchLink fieldCode="DE" term="%22Spinal+cord%22">Spinal cord</searchLink><br /><searchLink fieldCode="DE" term="%22Failed+back+surgery+syndrome%22">Failed back surgery syndrome</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+hypothesis+testing%22">Statistical hypothesis testing</searchLink><br /><searchLink fieldCode="DE" term="%22Epidural+space%22">Epidural space</searchLink><br /><searchLink fieldCode="DE" term="%22Neuralgia%22">Neuralgia</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s10072-020-04907-3 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 12 StartPage: 3285 Subjects: – SubjectFull: Neck pain Type: general – SubjectFull: Spinal cord Type: general – SubjectFull: Failed back surgery syndrome Type: general – SubjectFull: Statistical hypothesis testing Type: general – SubjectFull: Epidural space Type: general – SubjectFull: Neuralgia Type: general Titles: – TitleFull: Multicentre, clinical trial of burst spinal cord stimulation for neck and upper limb pain NU-BURST: a trial protocol. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Al-Kaisy, Adnan – PersonEntity: Name: NameFull: Vajramani, Girish – PersonEntity: Name: NameFull: Love-Jones, Sarah – PersonEntity: Name: NameFull: Patel, Nikunj K. – PersonEntity: Name: NameFull: Royds, Jonathan – PersonEntity: Name: NameFull: Palmisani, Stefano – PersonEntity: Name: NameFull: Pang, David – PersonEntity: Name: NameFull: Wesley, Samuel – PersonEntity: Name: NameFull: Park, Hyun-Joo – PersonEntity: Name: NameFull: Raza, Adil – PersonEntity: Name: NameFull: Agnesi, Filippo IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: Aug2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 15901874 Numbering: – Type: volume Value: 42 – Type: issue Value: 8 Titles: – TitleFull: Neurological Sciences Type: main |
| ResultId | 1 |
