Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

Abstract Background Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanist...

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Autores principales:	Selina Johnson, Anne Marshall, Dyfrig Hughes, Emily Holmes, Florian Henrich, Turo Nurmikko, Manohar Sharma, Bernhard Frank, Paul Bassett, Andrew Marshall, Walter Magerl, Andreas Goebel
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Peripheral nerve stimulation Peripheral neuropathic pain Long term depression Chronic pain Low frequency Medicine R
Acceso en línea:	https://doaj.org/article/86be584b4caf43d598f28508c0bc0b20
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spelling	oai:doaj.org-article:86be584b4caf43d598f28508c0bc0b202021-11-07T12:08:23ZMechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial10.1186/s12967-021-03128-21479-5876https://doaj.org/article/86be584b4caf43d598f28508c0bc0b202021-11-01T00:00:00Zhttps://doi.org/10.1186/s12967-021-03128-2https://doaj.org/toc/1479-5876Abstract Background Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain. Methods (1) Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 min/day). The primary outcome was average pain intensity (0–10 Likert scale) recorded over 1 week, at 3 months, compared between study groups. (2) On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS. Results (1) 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0.3 units lower in active group (95% CI − 1.0, 0.3; p = 0.30) giving an effect size of 0.19 (Cohen’s D). Two non-device related serious adverse events were reported. (2) In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia. Conclusions Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Trial registration ISRCTN53432663.Selina JohnsonAnne MarshallDyfrig HughesEmily HolmesFlorian HenrichTuro NurmikkoManohar SharmaBernhard FrankPaul BassettAndrew MarshallWalter MagerlAndreas GoebelBMCarticlePeripheral nerve stimulationPeripheral neuropathic painLong term depressionChronic painLow frequencyMedicineRENJournal of Translational Medicine, Vol 19, Iss 1, Pp 1-15 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Peripheral nerve stimulation Peripheral neuropathic pain Long term depression Chronic pain Low frequency Medicine R
spellingShingle	Peripheral nerve stimulation Peripheral neuropathic pain Long term depression Chronic pain Low frequency Medicine R Selina Johnson Anne Marshall Dyfrig Hughes Emily Holmes Florian Henrich Turo Nurmikko Manohar Sharma Bernhard Frank Paul Bassett Andrew Marshall Walter Magerl Andreas Goebel Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
description	Abstract Background Induction of long-term synaptic depression (LTD) is proposed as a treatment mechanism for chronic pain but remains untested in clinical populations. Two interlinked studies; (1) A patient-assessor blinded, randomised, sham-controlled clinical trial and (2) an open-label mechanistic study, sought to examine therapeutic LTD for persons with chronic peripheral nerve injury pain. Methods (1) Patients were randomised using a concealed, computer-generated schedule to either active or sham non-invasive low-frequency nerve stimulation (LFS), for 3 months (minimum 10 min/day). The primary outcome was average pain intensity (0–10 Likert scale) recorded over 1 week, at 3 months, compared between study groups. (2) On trial completion, consenting subjects entered a mechanistic study assessing somatosensory changes in response to LFS. Results (1) 76 patients were randomised (38 per group), with 65 (31 active, 34 sham) included in the intention to treat analysis. The primary outcome was not significant, pain scores were 0.3 units lower in active group (95% CI − 1.0, 0.3; p = 0.30) giving an effect size of 0.19 (Cohen’s D). Two non-device related serious adverse events were reported. (2) In the mechanistic study (n = 19) primary outcomes of mechanical pain sensitivity (p = 0.006) and dynamic mechanical allodynia (p = 0.043) significantly improved indicating reduced mechanical hyperalgesia. Conclusions Results from the RCT failed to reach significance. Results from the mechanistic study provide new evidence for effective induction of LTD in a clinical population. Taken together results add to mechanistic understanding of LTD and help inform future study design and approaches to treatment. Trial registration ISRCTN53432663.
format	article
author	Selina Johnson Anne Marshall Dyfrig Hughes Emily Holmes Florian Henrich Turo Nurmikko Manohar Sharma Bernhard Frank Paul Bassett Andrew Marshall Walter Magerl Andreas Goebel
author_facet	Selina Johnson Anne Marshall Dyfrig Hughes Emily Holmes Florian Henrich Turo Nurmikko Manohar Sharma Bernhard Frank Paul Bassett Andrew Marshall Walter Magerl Andreas Goebel
author_sort	Selina Johnson
title	Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
title_short	Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
title_full	Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
title_fullStr	Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
title_full_unstemmed	Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
title_sort	mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/86be584b4caf43d598f28508c0bc0b20
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Mechanistically informed non-invasive peripheral nerve stimulation for peripheral neuropathic pain: a randomised double-blind sham-controlled trial

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