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

Abstract

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.

Complexity Assessment of Chronic Pain in Elderly Knee Osteoarthritis Based on Neuroimaging Recognition Techniques

“…OA patients have decreased ability to perform basic daily activities (e.g., climbing stairs, changing from a sitting to a standing position). The main symptoms of osteoarthritis of the knee are pain, stiffness, reduced range of motion, twisting pain, and swelling [ 13 ]. Pain in the early course of the disease is usually described as a dull intermittent pain, confined to one chamber.…”

Source localized infraslow neurofeedback training in people with chronic painful knee osteoarthritis: A randomized, double-blind, sham-controlled feasibility clinical trial

“…The description of the study intervention was structured following the Template for Intervention Description and Replication (TIDieR) guide ( Hoffmann et al, 2014 ). The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000273987), and the study protocol was published in a peer-reviewed journal ( Mathew et al, 2020 ). This study was approved by the Health and Disability Ethics Committee (HDEC), New Zealand (19CEN182), and the cultural consultation was obtained from the Ngāi Tahu Research Consultation Committee (5733_21392).…”

“…A summary of the outcome measures is given in Supplementary Table 1 . Details including psychometric properties and the method of implementation of each tool are explained in the protocol ( Mathew et al, 2020 ).…”

“…Quantitative Sensory Testing (QST) procedures including pressure pain threshold (PPT), mechanical temporal summation (MTS), conditioned pain modulation (CPM), vibration perception threshold, cold hyperalgesia, tactile acuity, and body schema integrity ( Rolke et al, 2006 ; Georgopoulos et al, 2019 ) are detailed in the published protocol ( Mathew et al, 2020 ) and are also summarized in ( Supplemental Digital Content ).…”

“…Currently, there is no evidence of the efficacy of ISF-NF training in people with pain. Moreover, there is no evidence on the safety, feasibility, and acceptability of the ISF-NF training as an intervention for persistent pain ( Mathew et al, 2020 ). Therefore, the objectives of the study were: (1) to assess the feasibility, safety, and acceptability of ISF-NF training in individuals with KOA; (2) to descriptively report the variability of change in the clinical and experimental pain outcomes in people with KOA following NF training; (3) to descriptively explore the changes in EEG current source density (CSD) at the targeted cortical areas (SSC, dACC, and pgACC), functional connectivity between the three cortical areas (SSC, dACC, and pgACC), and the CSD ratios between the ROIs (SSC, dACC, and pgACC) following ISF-NF training.…”