To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial

Raymond Chadwick; Rebekah McNaughton; Sam Eldabe; Ganesan Baranidharan; Jill Bell; Morag Brooks; Rui V. Duarte; Jenny Earle; Ashish P. Gulve; Rachel Houten; Susan Jowett; Anu Kansal; Shelley Rhodes; Jennifer Robinson; Sara Griffiths; Rod Taylor; Simon Thomson; Harbinder Sandhu

doi:10.1111/ner.13316

To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial

Raymond Chadwick, Rebekah McNaughton, Sam Eldabe, Ganesan Baranidharan, Jill Bell, Morag Brooks, Rui V. Duarte, Jenny Earle, Ashish P. Gulve, Rachel Houten, Susan Jowett, Anu Kansal, Shelley Rhodes, Jennifer Robinson, Sara Griffiths, Rod Taylor, Simon Thomson, Harbinder Sandhu

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Abstract

Objectives

Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL‐STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL‐STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not.
Materials and Methods

We interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow‐up). Interviews were undertaken by telephone and audio‐recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one‐stage (no screening trial) versus two‐stage (screening trial) implant procedure on a five‐point Likert scale, before and after implantation.
Results

Emergent themes favoured the option for a one‐stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having “loose wires” in the two‐stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one‐stage procedure without a screening trial.
Conclusions

Our findings indicate an overwhelming preference among participants for a one‐stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL‐STIM RCT results.

Original language	English
Number of pages	12
Journal	Neuromodulation
DOIs	https://doi.org/10.1111/ner.13316
Publication status	Published - 1 Dec 2020

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Chadwick, R., McNaughton, R., Eldabe, S., Baranidharan, G., Bell, J., Brooks, M., Duarte, R. V., Earle, J., Gulve, A. P., Houten, R., Jowett, S., Kansal, A., Rhodes, S., Robinson, J., Griffiths, S., Taylor, R., Thomson, S., & Sandhu, H. (2020). To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial. Neuromodulation. https://doi.org/10.1111/ner.13316

@article{8076fea95a524e3dbe3180bcf72158e9,

title = "To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients{\textquoteright} view from the TRIAL-STIM randomised controlled trial",

abstract = "ObjectivesSpinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL‐STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL‐STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not.Materials and MethodsWe interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow‐up). Interviews were undertaken by telephone and audio‐recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one‐stage (no screening trial) versus two‐stage (screening trial) implant procedure on a five‐point Likert scale, before and after implantation.ResultsEmergent themes favoured the option for a one‐stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having “loose wires” in the two‐stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one‐stage procedure without a screening trial.ConclusionsOur findings indicate an overwhelming preference among participants for a one‐stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL‐STIM RCT results.",

author = "Raymond Chadwick and Rebekah McNaughton and Sam Eldabe and Ganesan Baranidharan and Jill Bell and Morag Brooks and Duarte, {Rui V.} and Jenny Earle and Gulve, {Ashish P.} and Rachel Houten and Susan Jowett and Anu Kansal and Shelley Rhodes and Jennifer Robinson and Sara Griffiths and Rod Taylor and Simon Thomson and Harbinder Sandhu",

year = "2020",

month = dec,

day = "1",

doi = "10.1111/ner.13316",

language = "English",

journal = "Neuromodulation",

issn = "1094-7159",

publisher = "Wiley-Blackwell Publishing Ltd",

}

Chadwick, R, McNaughton, R, Eldabe, S, Baranidharan, G, Bell, J, Brooks, M, Duarte, RV, Earle, J, Gulve, AP, Houten, R, Jowett, S, Kansal, A, Rhodes, S, Robinson, J, Griffiths, S, Taylor, R, Thomson, S & Sandhu, H 2020, 'To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial', Neuromodulation. https://doi.org/10.1111/ner.13316

TY - JOUR

T1 - To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial

AU - Chadwick, Raymond

AU - McNaughton, Rebekah

AU - Eldabe, Sam

AU - Baranidharan, Ganesan

AU - Bell, Jill

AU - Brooks, Morag

AU - Duarte, Rui V.

AU - Earle, Jenny

AU - Gulve, Ashish P.

AU - Houten, Rachel

AU - Jowett, Susan

AU - Kansal, Anu

AU - Rhodes, Shelley

AU - Robinson, Jennifer

AU - Griffiths, Sara

AU - Taylor, Rod

AU - Thomson, Simon

AU - Sandhu, Harbinder

PY - 2020/12/1

Y1 - 2020/12/1

N2 - ObjectivesSpinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL‐STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL‐STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not.Materials and MethodsWe interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow‐up). Interviews were undertaken by telephone and audio‐recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one‐stage (no screening trial) versus two‐stage (screening trial) implant procedure on a five‐point Likert scale, before and after implantation.ResultsEmergent themes favoured the option for a one‐stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having “loose wires” in the two‐stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one‐stage procedure without a screening trial.ConclusionsOur findings indicate an overwhelming preference among participants for a one‐stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL‐STIM RCT results.

AB - ObjectivesSpinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL‐STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL‐STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not.Materials and MethodsWe interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow‐up). Interviews were undertaken by telephone and audio‐recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one‐stage (no screening trial) versus two‐stage (screening trial) implant procedure on a five‐point Likert scale, before and after implantation.ResultsEmergent themes favoured the option for a one‐stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having “loose wires” in the two‐stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one‐stage procedure without a screening trial.ConclusionsOur findings indicate an overwhelming preference among participants for a one‐stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL‐STIM RCT results.

U2 - 10.1111/ner.13316

DO - 10.1111/ner.13316

M3 - Article

SN - 1094-7159

JO - Neuromodulation

JF - Neuromodulation

ER -

To trial or not to trial before Spinal Cord Stimulation for chronic neuropathic pain: the patients’ view from the TRIAL-STIM randomised controlled trial

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