Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]

Background Following Spinal Cord Injury (SCI), 53% of people develop neuropathic pain (NP). NP can be more debilitating than other consequences of SCI, and a persistent health issue. Pharmacotherapies are commonly recommended for NP management in SCI, although severe pain often remains refractory to...

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Main Authors: Orlaith Doherty, Conor White, Nanna Brix Finnerup, Eimear Smith, Mark Pollock, Nathan Kirwan, Olive Lennon, Catherine Blake
Format: Article
Language:English
Published: F1000 Research Ltd 2024-09-01
Series:HRB Open Research
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Online Access:https://hrbopenresearch.org/articles/7-55/v1
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author Orlaith Doherty
Conor White
Nanna Brix Finnerup
Eimear Smith
Mark Pollock
Nathan Kirwan
Olive Lennon
Catherine Blake
author_facet Orlaith Doherty
Conor White
Nanna Brix Finnerup
Eimear Smith
Mark Pollock
Nathan Kirwan
Olive Lennon
Catherine Blake
author_sort Orlaith Doherty
collection DOAJ
description Background Following Spinal Cord Injury (SCI), 53% of people develop neuropathic pain (NP). NP can be more debilitating than other consequences of SCI, and a persistent health issue. Pharmacotherapies are commonly recommended for NP management in SCI, although severe pain often remains refractory to these treatments in many sufferers. Furthermore, poor medication adherence exists, stemming from unacceptable side-effects and fear of dependency. Sensorimotor stimulation using active walking with robotic assistance has not been well studied in NP after SCI, despite convincing locomotor-based pre-clinical studies, identifying prevention and reversal of NP. Our primary aim is to assess the impact of exoskeleton-based walking on NP intensity and interference after SCI and examine feasibility outcomes for progression to a definitive trial. Methods This is a phase 2 single-blinded, randomised feasibility study. It will test the feasibility and acceptability of exoskeleton-based walking 3 times per week for 12 weeks (intervention), as a mechanistic-based intervention for NP after SCI. The comparator will be an equally dosed, blended relaxation programme devoid of motor imagery prompts. 40 participants with moderate-to-severe NP post SCI will be recruited and randomised to intervention and comparator groups. The primary outcomes are feasibility outcomes for progression to definitive trial which include recruitment and retention rates, adverse events and acceptability of the intervention. Secondary outcomes explore changes in NP intensity and interference as measured by the International Spinal Cord Injury Pain Basic Data Set 3.0 (ISCIPBDS) at baseline, post-intervention (week 13) and at 6-month follow-up. Conclusions There is a need to explore non-pharmacological management of NP after SCI. The findings of this feasibility trial will inform the development of a future multicentre, international RCT, Trial Registration NCT06463418, 08/07/2024, https://clinicaltrials.gov/study/NCT06463418.
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spelling doaj-art-12f5873964104488b576c5d91bd29f842025-01-18T01:00:00ZengF1000 Research LtdHRB Open Research2515-48262024-09-01715305Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]Orlaith Doherty0Conor White1https://orcid.org/0000-0003-1524-3673Nanna Brix Finnerup2Eimear Smith3https://orcid.org/0000-0002-3739-0749Mark Pollock4Nathan Kirwan5Olive Lennon6https://orcid.org/0000-0001-7005-3616Catherine Blake7https://orcid.org/0000-0002-0600-629XUCD School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Dublin, Leinster, IrelandUCD School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Dublin, Leinster, IrelandAarhus University Department of Clinical Medicine, Aarhus, Central Denmark Region, DenmarkNational Rehabilitation Hospital, Dún Laoghaire, County Dublin, IrelandMark Pollock Trust, Dublin, IrelandHelpful Steps Charity, Cork, IrelandUCD School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Dublin, Leinster, IrelandUCD School of Public Health, Physiotherapy and Sports Science, Health Sciences Centre, University College Dublin, Dublin, Leinster, IrelandBackground Following Spinal Cord Injury (SCI), 53% of people develop neuropathic pain (NP). NP can be more debilitating than other consequences of SCI, and a persistent health issue. Pharmacotherapies are commonly recommended for NP management in SCI, although severe pain often remains refractory to these treatments in many sufferers. Furthermore, poor medication adherence exists, stemming from unacceptable side-effects and fear of dependency. Sensorimotor stimulation using active walking with robotic assistance has not been well studied in NP after SCI, despite convincing locomotor-based pre-clinical studies, identifying prevention and reversal of NP. Our primary aim is to assess the impact of exoskeleton-based walking on NP intensity and interference after SCI and examine feasibility outcomes for progression to a definitive trial. Methods This is a phase 2 single-blinded, randomised feasibility study. It will test the feasibility and acceptability of exoskeleton-based walking 3 times per week for 12 weeks (intervention), as a mechanistic-based intervention for NP after SCI. The comparator will be an equally dosed, blended relaxation programme devoid of motor imagery prompts. 40 participants with moderate-to-severe NP post SCI will be recruited and randomised to intervention and comparator groups. The primary outcomes are feasibility outcomes for progression to definitive trial which include recruitment and retention rates, adverse events and acceptability of the intervention. Secondary outcomes explore changes in NP intensity and interference as measured by the International Spinal Cord Injury Pain Basic Data Set 3.0 (ISCIPBDS) at baseline, post-intervention (week 13) and at 6-month follow-up. Conclusions There is a need to explore non-pharmacological management of NP after SCI. The findings of this feasibility trial will inform the development of a future multicentre, international RCT, Trial Registration NCT06463418, 08/07/2024, https://clinicaltrials.gov/study/NCT06463418.https://hrbopenresearch.org/articles/7-55/v1Spinal Cord Injuries Neuropathic Pain Robotics Adult Neurorehabilitation eng
spellingShingle Orlaith Doherty
Conor White
Nanna Brix Finnerup
Eimear Smith
Mark Pollock
Nathan Kirwan
Olive Lennon
Catherine Blake
Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
HRB Open Research
Spinal Cord Injuries
Neuropathic Pain
Robotics
Adult
Neurorehabilitation
eng
title Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
title_full Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
title_fullStr Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
title_full_unstemmed Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
title_short Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial [version 1; peer review: 1 approved, 2 approved with reservations]
title_sort exoskeleton training for spinal cord injury neuropathic pain exscip protocol for a phase 2 feasibility randomised trial version 1 peer review 1 approved 2 approved with reservations
topic Spinal Cord Injuries
Neuropathic Pain
Robotics
Adult
Neurorehabilitation
eng
url https://hrbopenresearch.org/articles/7-55/v1
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