High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial

What this Trial Is About

Researchers are evaluating the use of a non-invasive brain stimulation technique called High-definition Transcranial Infraslow Gray Noise Stimulation (HD-tIGNS) in adults with chronic low back pain. This randomized, double-blind clinical trial aims to assess how well this brain stimulation improves pain intensity, its safety, possible side effects, and participants' perceptions of the treatment process. The study is led by the University of Otago and includes adults aged 18 to 75 years who have experienced lower back pain for at least half the days in the past six months. Participants will be randomly assigned to either an active brain stimulation group or a sham (placebo) stimulation group. Both groups will receive 12 sessions over four weeks, with three one-hour sessions per week. The active group will receive 30 minutes of HD-tIGNS per session, with specific electrode placements delivering targeted brain stimulation, while the sham group will experience brief initial sensations mimicking the active treatment without ongoing stimulation to maintain blinding. Throughout the study, participants will undergo assessments at the start, immediately after treatment completion, and at one, three, and six months post-treatment. These evaluations include measuring pain intensity, pain interference, movement-evoked pain, functional abilities, quality of life, mental health factors, and brain activity using EEG and cognitive tasks. Researchers will also monitor safety, side effects, and participants' experiences with the treatment and study procedures, with total participation lasting over six months.

Brain Network Stimulation for Chronic Low Back Pain.