Protocol for a Pilot Randomized Sham-Controlled Clinical Trial Evaluating the Feasibility, Safety, and Acceptability of Infraslow Electroencephalography Neurofeedback Training on Experimental and Clinical Pain Outcomes in People with Chronic Painful Knee

Introduction: Persistent pain is a significant contributor to disability in people living with knee osteoarthritis (KOA). Brain imaging, including electrophysiological studies, confirms altered cortical oscillatory and synchrony patterns in cognitive, affective, and somatosensory areas in individuals with KOA pain. Electroencephalography neurofeedback (EEG-NF) training is a form of neuromodulatory intervention that can help to reduce pain via normalizing dysrhythmic cortical oscillatory patterns that are linked to the pain experience. However, there is a dearth of evidence towards the efficacy of NF in individuals with musculoskeletal pain. Aim: The proposed research is intended to pilot the NF training protocol and assess the feasibility, safety, and acceptability of NF training in individuals with KOA and estimate the variability of experimental and clinical outcome measures following NF training. Design: A parallel, two-armed, double-blind (participant and assessor) pilot randomized sham-controlled clinical trial. Methods: Adults aged 44–75 years with a clinical diagnosis of KOA will be recruited and randomized to either active or sham EEG-NF training. Both groups will receive auditory feedback as a reward for achieving a predetermined activity threshold of the target areas of the brain. Outcome measures include feasibility measures (recruitment, randomization, retention, and dropout rates), acceptability, and adverse events; clinical measures (pain, interference, sleep, mood, and physical activity); and experimental pain outcomes (quantitative sensory testing procedures). Discussion: Outcomes from this study will inform the feasibility and methodology for a future randomized controlled clinical trial.