JMIR Publications

ABSTRACT

Background:

Neuropathic pain is characterised as pain arising from lesions of the somatosensory nervous system. However, neuropathic pain (NP)-like features have been found in several chronic secondary musculoskeletal (MSK) pain conditions in the absence of detectable lesion or damage to the somatosensory pathways. Emerging evidence has demonstrated associations between NP-like symptoms and altered neural activity within brain regions implicated in sensory perception and affective-emotional processing of pain with consistent findings of abnormal activity in the right insular cortex (RIns) and dorsal anterior cingulate cortex (dACC).

Objective:

The primary objective of this study is to investigate the feasibility and safety of a novel electroencephalography neurofeedback (EEG-NF) intervention designed to simultaneously down train activity in the RIns and dACC in individuals with a chronic secondary MSK pain condition exhibiting NP-like features. In addition, the study will conduct secondary exploratory analyses to investigate EEG-derived neuronal changes and their associations with clinical and experimental pain outcomes following the EEG-NF training.

Methods:

A single-arm, open-label, pilot-feasibility trial will be designed. Adults 35-75 years old with a score of ≥19 using the PainDETECT questionnaire and an average pain score of ≥4 on the 11-point Numeric Pain Rating Scale over the last three months for a minimum duration of three months will be recruited and receive active EEG-NF training. Participants will receive auditory feedback as a reward for achieving a predetermined activity threshold of the RIns and dACC. Primary outcomes will assess feasibility, acceptability, and safety. Secondary outcomes will include EEG parameters, self-reported measures, heart rate variability (HRV), and outcomes from quantitative sensory testing (QST).

Results:

Patient demographics, feasibility, and safety data over the course of the study will be descriptively summarised and means and standard deviations will be derived. A within-group pre-post statistical comparison will be conducted for all the secondary outcome measures using GraphPad Prism software. Correlation analysis will be performed to explore relationship between EEG measures, self-reported outcomes, HRV and QST measures

Conclusions:

The findings from this study will provide preliminary evidence regarding the safety and feasibility of the novel EEG-NF intervention. The results and data generated will inform the design and sample size calculation for a fully powered randomized controlled trial aimed at evaluating the effectiveness of EEG-NF in targeting NP-like features in individuals with chronic MSK pain. Clinical Trial: Australia New Zealand Clinical Trial Registry request ID: 389568