Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)?: 36-Month Results From a Randomized Controlled Trial

Sam Eldabe; Sarah Nevitt; Sara Griffiths; Ashish Gulve; Simon Thomson; Ganesan Baranidharan; Rachel Houten; Morag Brookes; Anu Kansal; Jenny Earle; Jill Bell; Rod S Taylor; Rui V Duarte

doi:10.1227/neu.0000000000002165

Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial

Sam Eldabe, Sarah Nevitt, Sara Griffiths, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rachel Houten, Morag Brookes, Anu Kansal, Jenny Earle, Jill Bell, Rod S Taylor, Rui V Duarte

Centre for Reviews and Dissemination

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a screening trial and that it was not cost-effective.

OBJECTIVE: To report the long-term follow-up results of the TRIAL-STIM study.

METHODS: The primary outcome of this pragmatic randomized controlled trial was pain intensity as measured on a numerical rating scale (NRS) and secondary outcomes were the proportion of patients achieving at least 50% and 30% pain relief at 6 months, health-related quality of life, and complication rates.

RESULTS: Thirty patients allocated to the "Trial Group" (TG) and 36 patients allocated to the "No Trial Group" (NTG) completed outcome assessment at 36-month follow-up. Although there was a reduction in NRS pain and improvements in utility scores from baseline to 36 months in both groups, there was no difference in the primary outcome of pain intensity NRS between TG and NTG (adjusted mean difference: -0.60, 95% CI: -1.83 to 0.63), EuroQol-5 Dimension utility values (adjusted mean difference: -0.02, 95% CI: -0.13 to 0.10), or proportion of pain responders (33% TG vs 31% NTG). No differences were observed between the groups for the likelihood of spinal cord stimulation device explant or reporting an adverse advent up to 36-month follow-up.

CONCLUSION: The long-term results show no patient outcome benefit in undertaking an SCS screening trial.

Original language	English
Pages (from-to)	75-82
Number of pages	8
Journal	Neurosurgery
Volume	92
Issue number	1
Early online date	13 Oct 2022
DOIs	https://doi.org/10.1227/neu.0000000000002165
Publication status	Published - 1 Jan 2023

Bibliographical note

Keywords

Humans
Spinal Cord Stimulation/methods
Chronic Pain/diagnosis
Quality of Life
Neuralgia/diagnosis
Treatment Outcome
Spinal Cord

Access to Document

10.1227/neu.0000000000002165Licence: CC BY

Cite this

Eldabe, S., Nevitt, S., Griffiths, S., Gulve, A., Thomson, S., Baranidharan, G., Houten, R., Brookes, M., Kansal, A., Earle, J., Bell, J., Taylor, R. S., & Duarte, R. V. (2023). Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial. Neurosurgery, 92(1), 75-82. https://doi.org/10.1227/neu.0000000000002165

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title = "Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)?: 36-Month Results From a Randomized Controlled Trial",

abstract = "BACKGROUND: Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a screening trial and that it was not cost-effective.OBJECTIVE: To report the long-term follow-up results of the TRIAL-STIM study.METHODS: The primary outcome of this pragmatic randomized controlled trial was pain intensity as measured on a numerical rating scale (NRS) and secondary outcomes were the proportion of patients achieving at least 50% and 30% pain relief at 6 months, health-related quality of life, and complication rates.RESULTS: Thirty patients allocated to the {"}Trial Group{"} (TG) and 36 patients allocated to the {"}No Trial Group{"} (NTG) completed outcome assessment at 36-month follow-up. Although there was a reduction in NRS pain and improvements in utility scores from baseline to 36 months in both groups, there was no difference in the primary outcome of pain intensity NRS between TG and NTG (adjusted mean difference: -0.60, 95% CI: -1.83 to 0.63), EuroQol-5 Dimension utility values (adjusted mean difference: -0.02, 95% CI: -0.13 to 0.10), or proportion of pain responders (33% TG vs 31% NTG). No differences were observed between the groups for the likelihood of spinal cord stimulation device explant or reporting an adverse advent up to 36-month follow-up.CONCLUSION: The long-term results show no patient outcome benefit in undertaking an SCS screening trial.",

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author = "Sam Eldabe and Sarah Nevitt and Sara Griffiths and Ashish Gulve and Simon Thomson and Ganesan Baranidharan and Rachel Houten and Morag Brookes and Anu Kansal and Jenny Earle and Jill Bell and Taylor, {Rod S} and Duarte, {Rui V}",

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doi = "10.1227/neu.0000000000002165",

language = "English",

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Eldabe, S, Nevitt, S, Griffiths, S, Gulve, A, Thomson, S, Baranidharan, G, Houten, R, Brookes, M, Kansal, A, Earle, J, Bell, J, Taylor, RS & Duarte, RV 2023, 'Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial', Neurosurgery, vol. 92, no. 1, pp. 75-82. https://doi.org/10.1227/neu.0000000000002165

TY - JOUR

T1 - Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)?

T2 - 36-Month Results From a Randomized Controlled Trial

AU - Eldabe, Sam

AU - Nevitt, Sarah

AU - Griffiths, Sara

AU - Gulve, Ashish

AU - Thomson, Simon

AU - Baranidharan, Ganesan

AU - Houten, Rachel

AU - Brookes, Morag

AU - Kansal, Anu

AU - Earle, Jenny

AU - Bell, Jill

AU - Taylor, Rod S

AU - Duarte, Rui V

PY - 2023/1/1

Y1 - 2023/1/1

N2 - BACKGROUND: Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a screening trial and that it was not cost-effective.OBJECTIVE: To report the long-term follow-up results of the TRIAL-STIM study.METHODS: The primary outcome of this pragmatic randomized controlled trial was pain intensity as measured on a numerical rating scale (NRS) and secondary outcomes were the proportion of patients achieving at least 50% and 30% pain relief at 6 months, health-related quality of life, and complication rates.RESULTS: Thirty patients allocated to the "Trial Group" (TG) and 36 patients allocated to the "No Trial Group" (NTG) completed outcome assessment at 36-month follow-up. Although there was a reduction in NRS pain and improvements in utility scores from baseline to 36 months in both groups, there was no difference in the primary outcome of pain intensity NRS between TG and NTG (adjusted mean difference: -0.60, 95% CI: -1.83 to 0.63), EuroQol-5 Dimension utility values (adjusted mean difference: -0.02, 95% CI: -0.13 to 0.10), or proportion of pain responders (33% TG vs 31% NTG). No differences were observed between the groups for the likelihood of spinal cord stimulation device explant or reporting an adverse advent up to 36-month follow-up.CONCLUSION: The long-term results show no patient outcome benefit in undertaking an SCS screening trial.

AB - BACKGROUND: Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a screening trial and that it was not cost-effective.OBJECTIVE: To report the long-term follow-up results of the TRIAL-STIM study.METHODS: The primary outcome of this pragmatic randomized controlled trial was pain intensity as measured on a numerical rating scale (NRS) and secondary outcomes were the proportion of patients achieving at least 50% and 30% pain relief at 6 months, health-related quality of life, and complication rates.RESULTS: Thirty patients allocated to the "Trial Group" (TG) and 36 patients allocated to the "No Trial Group" (NTG) completed outcome assessment at 36-month follow-up. Although there was a reduction in NRS pain and improvements in utility scores from baseline to 36 months in both groups, there was no difference in the primary outcome of pain intensity NRS between TG and NTG (adjusted mean difference: -0.60, 95% CI: -1.83 to 0.63), EuroQol-5 Dimension utility values (adjusted mean difference: -0.02, 95% CI: -0.13 to 0.10), or proportion of pain responders (33% TG vs 31% NTG). No differences were observed between the groups for the likelihood of spinal cord stimulation device explant or reporting an adverse advent up to 36-month follow-up.CONCLUSION: The long-term results show no patient outcome benefit in undertaking an SCS screening trial.

KW - Humans

KW - Spinal Cord Stimulation/methods

KW - Chronic Pain/diagnosis

KW - Quality of Life

KW - Neuralgia/diagnosis

KW - Treatment Outcome

KW - Spinal Cord

U2 - 10.1227/neu.0000000000002165

DO - 10.1227/neu.0000000000002165

M3 - Article

C2 - 36226961

SN - 0148-396X

VL - 92

SP - 75

EP - 82

JO - Neurosurgery

JF - Neurosurgery

IS - 1

ER -