Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial

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Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial. / Eldabe, Sam; Duarte, Rui V; Gulve, Ashish; Thomson, Simon; Baranidharan, Ganesan ; Houten, Rachel ; Jowett, Sue; Sandhu, Harbinder ; Chadwick, Raymond ; Brookes, Morag; Kansal, Anu ; Earle, Jenny ; Bell, Jill ; Robinson, Jennifer ; Walker, Sarah; Rhodes, Shelley ; Taylor, Rod.

In: Pain, Vol. 161, No. 12, 12.2020, p. 2820-2829.

Research output: Contribution to journalArticlepeer-review

Harvard

Eldabe, S, Duarte, RV, Gulve, A, Thomson, S, Baranidharan, G, Houten, R, Jowett, S, Sandhu, H, Chadwick, R, Brookes, M, Kansal, A, Earle, J, Bell, J, Robinson, J, Walker, S, Rhodes, S & Taylor, R 2020, 'Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial', Pain, vol. 161, no. 12, pp. 2820-2829. https://doi.org/10.1097/j.pain.0000000000001977

APA

Eldabe, S., Duarte, R. V., Gulve, A., Thomson, S., Baranidharan, G., Houten, R., Jowett, S., Sandhu, H., Chadwick, R., Brookes, M., Kansal, A., Earle, J., Bell, J., Robinson, J., Walker, S., Rhodes, S., & Taylor, R. (2020). Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial. Pain, 161(12), 2820-2829. https://doi.org/10.1097/j.pain.0000000000001977

Vancouver

Author

Eldabe, Sam ; Duarte, Rui V ; Gulve, Ashish ; Thomson, Simon ; Baranidharan, Ganesan ; Houten, Rachel ; Jowett, Sue ; Sandhu, Harbinder ; Chadwick, Raymond ; Brookes, Morag ; Kansal, Anu ; Earle, Jenny ; Bell, Jill ; Robinson, Jennifer ; Walker, Sarah ; Rhodes, Shelley ; Taylor, Rod. / Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial. In: Pain. 2020 ; Vol. 161, No. 12. pp. 2820-2829.

Bibtex

@article{0e64a2c051164b7285398f2fa1361a4c,
title = "Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial",
abstract = "Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at three centres in United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at six-months follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51). Mean NRS pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6-months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% CI: -1.2 to 0.9, p=0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25). The mean incremental cost-effectiveness ratio of TG versus NTG was £78,895 per additional quality-adjusted life-year (QALY) gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening trial strategy provides superior patient outcomes or is cost-effective compared to a no trial screening approach.",
keywords = "randomised controlled trial, screening trial, spinal cord stimulation, neuropathic pain, cost-effectiveness",
author = "Sam Eldabe and Duarte, {Rui V} and Ashish Gulve and Simon Thomson and Ganesan Baranidharan and Rachel Houten and Sue Jowett and Harbinder Sandhu and Raymond Chadwick and Morag Brookes and Anu Kansal and Jenny Earle and Jill Bell and Jennifer Robinson and Sarah Walker and Shelley Rhodes and Rod Taylor",
year = "2020",
month = dec,
doi = "10.1097/j.pain.0000000000001977",
language = "English",
volume = "161",
pages = "2820--2829",
journal = "Pain",
issn = "0304-3959",
publisher = "Lippincott Williams and Wilkins",
number = "12",

}

RIS

TY - JOUR

T1 - Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial

AU - Eldabe, Sam

AU - Duarte, Rui V

AU - Gulve, Ashish

AU - Thomson, Simon

AU - Baranidharan, Ganesan

AU - Houten, Rachel

AU - Jowett, Sue

AU - Sandhu, Harbinder

AU - Chadwick, Raymond

AU - Brookes, Morag

AU - Kansal, Anu

AU - Earle, Jenny

AU - Bell, Jill

AU - Robinson, Jennifer

AU - Walker, Sarah

AU - Rhodes, Shelley

AU - Taylor, Rod

PY - 2020/12

Y1 - 2020/12

N2 - Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at three centres in United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at six-months follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51). Mean NRS pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6-months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% CI: -1.2 to 0.9, p=0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25). The mean incremental cost-effectiveness ratio of TG versus NTG was £78,895 per additional quality-adjusted life-year (QALY) gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening trial strategy provides superior patient outcomes or is cost-effective compared to a no trial screening approach.

AB - Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at three centres in United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at six-months follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51). Mean NRS pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6-months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% CI: -1.2 to 0.9, p=0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25). The mean incremental cost-effectiveness ratio of TG versus NTG was £78,895 per additional quality-adjusted life-year (QALY) gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening trial strategy provides superior patient outcomes or is cost-effective compared to a no trial screening approach.

KW - randomised controlled trial

KW - screening trial

KW - spinal cord stimulation

KW - neuropathic pain

KW - cost-effectiveness

UR - https://pubmed.ncbi.nlm.nih.gov/32618875/

U2 - 10.1097/j.pain.0000000000001977

DO - 10.1097/j.pain.0000000000001977

M3 - Article

C2 - 32618875

VL - 161

SP - 2820

EP - 2829

JO - Pain

JF - Pain

SN - 0304-3959

IS - 12

ER -