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Multicentre, double-blind, randomised, sham-controlled trial of 10 kHz high- frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol

Multicentre, double-blind, randomised, sham-controlled trial of 10 kHz high- frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol
Multicentre, double-blind, randomised, sham-controlled trial of 10 kHz high- frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol
Introduction: chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.

Methods: this is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.

Discussion: the outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.

Trial registration: Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018.

Disclaimer: the views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication.

Roles and Responsibilities: AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.


chronic neuropathic low back pain, neuromodulation, neuropathic pain, spinal cord stimulation
1745-6215
Al-Kaisy, Adnan
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Royds, Jonathan
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Palmisani, Stefano
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Pang, David
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Wesley, Samuel
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Taylor, Rod
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Cook, Andrew
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Eldabe, Sam
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McCracken, Lance
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Duarte, Rui
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Fairbank, Jeremy
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Al-Kaisy, Adnan
e410cdd6-9e86-41b5-b297-d4fe1124cfe7
Royds, Jonathan
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Palmisani, Stefano
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Pang, David
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Wesley, Samuel
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Taylor, Rod
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Cook, Andrew
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Eldabe, Sam
344d7649-7cb4-4b3b-b333-00fc92edba0d
McCracken, Lance
af8fedee-f2f6-4721-8cc6-7e3f209b4ec0
Duarte, Rui
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Fairbank, Jeremy
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Al-Kaisy, Adnan, Royds, Jonathan, Palmisani, Stefano, Pang, David, Wesley, Samuel, Taylor, Rod, Cook, Andrew, Eldabe, Sam, McCracken, Lance, Duarte, Rui and Fairbank, Jeremy (2020) Multicentre, double-blind, randomised, sham-controlled trial of 10 kHz high- frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol. Trials, 21 (111), [111]. (doi:10.1186/s13063-019-3831-4).

Record type: Article

Abstract

Introduction: chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. Evidence demonstrates that high-frequency 10 kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with failed back surgery syndrome (FBSS), but evidence of this effect is limited in individuals with CNLBP who have not had surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10 kHz SCS for this population.

Methods: this is a multicentre, double-blind, randomised, sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10 kHz SCS plus usual care (intervention group) or to sham 10 kHz SCS plus usual care (control group) after receiving the full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. The primary outcome will be a 7-day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5 L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6 months, while adjusting for baseline outcome scores. Incremental cost per quality-adjusted life year (QALY) will be calculated at 6 months and over the lifetime of the patient.

Discussion: the outcomes of this trial will inform clinical practice and healthcare policy on the role of high-frequency 10 kHz SCS for use in patients with CNLBP who have not had surgery.

Trial registration: Clinicaltrials.gov, NCT03470766. Registered on 20 March 2018.

Disclaimer: the views expressed here are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. The NIHR had no role in the study design, writing of the manuscript or the decision to submit for publication.

Roles and Responsibilities: AK, SP, DP, SW, RST, AC, SE, LM, RD and JF all contributed to the trial design and to securing trial funding. AK, JR, SP, DP, and SE are involved in the recruitment, the intervention and the follow-up. SW will perform data collection and analysis. RST will be responsible for the statistical analysis, and RD will be responsible for the health economic analysis. All authors read and approved the final manuscript.


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e-pub ahead of print date: 28 January 2020
Published date: 28 January 2020
Keywords: chronic neuropathic low back pain, neuromodulation, neuropathic pain, spinal cord stimulation

Identifiers

Local EPrints ID: 438057
URI: http://eprints.soton.ac.uk/id/eprint/438057
ISSN: 1745-6215
PURE UUID: d82c5e59-e914-43b1-9103-2d1337ad7b1c
ORCID for Andrew Cook: ORCID iD orcid.org/0000-0002-6680-439X

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Date deposited: 27 Feb 2020 17:30
Last modified: 28 Apr 2022 01:56

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Contributors

Author: Adnan Al-Kaisy
Author: Jonathan Royds
Author: Stefano Palmisani
Author: David Pang
Author: Samuel Wesley
Author: Rod Taylor
Author: Andrew Cook ORCID iD
Author: Sam Eldabe
Author: Lance McCracken
Author: Rui Duarte
Author: Jeremy Fairbank

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