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 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.