Suhood Ariane Y, Summers Simon, Stanton Tasha R, Thomson Daniel, McAuley James, Cashin Aidan, Jenkins Luke C, Alhassani Ghufran, McNally Keeley R, Gupta Amitabh, Cavaleri Rocco
Brain Stimulation and Rehabilitation (BrainStAR) Lab, School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.
School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.
BMJ Open. 2025 Jun 24;15(6):e096126. doi: 10.1136/bmjopen-2024-096126.
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.
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 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.
慢性腰痛是导致全球残疾和生活质量下降的主要原因之一。尽管投入了大量资金和进行了大量研究,但目前的干预措施仅取得了有限的成功,或者伴有有害的副作用。此外,大多数治疗措施针对的是已经发展为慢性的腰痛,而非首先能够预防疼痛慢性化的干预措施。经颅直流电刺激(tDCS)是一种便携且经济高效的非侵入性脑刺激形式,为针对急性疼痛并预防其转变为慢性疼痛提供了一种潜在方法。然而,这种方法主要局限于需要密集预约和专业知识的实验环境。因此,这项评估者、参与者和治疗师均盲法的随机对照试验旨在探讨居家tDCS对改善急性腰痛患者疼痛和功能障碍的有效性。这可能有助于深入了解tDCS加速急性腰痛恢复并预防疼痛慢性化的潜力。
将招募40名急性腰痛患者(发病时间在入组前<8周),并随机分配至为期2周的居家主动或假刺激tDCS治疗方案。参与者将参加五次实验室检查(干预前基线检查;干预结束时;干预结束后4周、8周和12周),在此期间收集疼痛处理和功能障碍的测量数据。还将评估治疗效果的机制因素(潜在中介因素),包括皮质运动组织(经颅磁刺激映射)、体感功能、脑电图和情感特征。参与者将在干预期内每天完成在线问卷,以评估疼痛强度,并监测安全性、治疗依从性和耐受性。通过分析这些结果在组内和组间随时间的变化,研究tDCS对改善急性腰痛患者疼痛和功能障碍的疗效。
已获得西悉尼大学人类研究伦理委员会(H16334)的伦理批准。研究结果将通过科学会议和同行评审期刊发表进行传播。