Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study

Introduction Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most...

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Main Authors: Luke C Jenkins, James McAuley, Aidan Cashin, Tasha R Stanton, Amitabh Gupta, Rocco Cavaleri, Simon Summers, Keeley R McNally, Ariane Y Suhood, Daniel Thomson, Ghufran Alhassani
Format: Article
Language:English
Published: BMJ Publishing Group 2025-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/6/e096126.full
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author Luke C Jenkins
James McAuley
Aidan Cashin
Tasha R Stanton
Amitabh Gupta
Rocco Cavaleri
Simon Summers
Keeley R McNally
Ariane Y Suhood
Daniel Thomson
Ghufran Alhassani
author_facet Luke C Jenkins
James McAuley
Aidan Cashin
Tasha R Stanton
Amitabh Gupta
Rocco Cavaleri
Simon Summers
Keeley R McNally
Ariane Y Suhood
Daniel Thomson
Ghufran Alhassani
author_sort Luke C Jenkins
collection DOAJ
description Introduction Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.Methods and analysis 40 individuals with acute LBP (onset <8 weeks prior to enrolment) will be recruited and randomly allocated to a 2-week treatment protocol of either active or sham home-based tDCS. Participants will attend five laboratory sessions (pre-intervention baseline; at intervention completion; 4 weeks, 8 weeks and 12 weeks post-completion of intervention) where measures of pain processing and disability will be collected. Mechanistic factors (potential mediators) of treatment effectiveness, including corticomotor organisation (transcranial magnetic stimulation mapping), somatosensory function, electroencephalography and affective-emotional characteristics, will also be assessed. Daily online questionnaires will be completed by participants during the intervention period to assess pain intensity and to monitor safety, treatment adherence and tolerability. The efficacy of tDCS in improving pain and disability in people with acute LBP will be investigated by analysing within-group and between-group changes in these outcomes over time.Ethics and dissemination Ethics approval has been granted by the Western Sydney University Human Research Ethics Committee (H16334). Findings will be disseminated through scientific conferences and peer-reviewed journal publication.
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spelling doaj-art-64718e6b9a8a48c0b8a4c86b8db2b8fa2025-08-20T03:32:40ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-096126Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled studyLuke C Jenkins0James McAuley1Aidan Cashin2Tasha R Stanton3Amitabh Gupta4Rocco Cavaleri5Simon Summers6Keeley R McNally7Ariane Y Suhood8Daniel Thomson9Ghufran Alhassani10School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaCentre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, AustraliaCentre for Pain IMPACT, Neuroscience Research Australia, Randwick, New South Wales, AustraliaIIMPACT in Health, University of South Australia, Adelaide, South Australia, AustraliaSchool of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaSchool of Biomedical Science, Queensland University of Technology, Brisbane, Queensland, AustraliaBrain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaBrain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaBrain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaBrain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaBrain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, AustraliaIntroduction Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.Methods and analysis 40 individuals with acute LBP (onset <8 weeks prior to enrolment) will be recruited and randomly allocated to a 2-week treatment protocol of either active or sham home-based tDCS. Participants will attend five laboratory sessions (pre-intervention baseline; at intervention completion; 4 weeks, 8 weeks and 12 weeks post-completion of intervention) where measures of pain processing and disability will be collected. Mechanistic factors (potential mediators) of treatment effectiveness, including corticomotor organisation (transcranial magnetic stimulation mapping), somatosensory function, electroencephalography and affective-emotional characteristics, will also be assessed. Daily online questionnaires will be completed by participants during the intervention period to assess pain intensity and to monitor safety, treatment adherence and tolerability. The efficacy of tDCS in improving pain and disability in people with acute LBP will be investigated by analysing within-group and between-group changes in these outcomes over time.Ethics and dissemination Ethics approval has been granted by the Western Sydney University Human Research Ethics Committee (H16334). Findings will be disseminated through scientific conferences and peer-reviewed journal publication.https://bmjopen.bmj.com/content/15/6/e096126.full
spellingShingle Luke C Jenkins
James McAuley
Aidan Cashin
Tasha R Stanton
Amitabh Gupta
Rocco Cavaleri
Simon Summers
Keeley R McNally
Ariane Y Suhood
Daniel Thomson
Ghufran Alhassani
Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
BMJ Open
title Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
title_full Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
title_fullStr Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
title_full_unstemmed Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
title_short Preventing the transition from acute to chronic low back pain using home-based neuromodulation: protocol for a randomised, controlled study
title_sort preventing the transition from acute to chronic low back pain using home based neuromodulation protocol for a randomised controlled study
url https://bmjopen.bmj.com/content/15/6/e096126.full
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