Feasibility and Safety of a Home-based Electroencephalogram Neurofeedback Intervention to Reduce Chronic Neuropathic Pain: A Cohort Clinical Trial

家庭脑电图神经反馈干预治疗慢性神经性疼痛的可行性和安全性:一项队列临床试验

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Abstract

OBJECTIVE: To evaluate the feasibility, safety, and potential health benefits of an 8-week home-based neurofeedback intervention. DESIGN: Single-group preliminary study. SETTING: Community-based. PARTICIPANTS: Nine community dwelling adults with chronic neuropathic pain, 6 women and 3 men, with an average age of 51.9 years (range, 19-78 years) and with a 7-day average minimum pain score of 4 of 10 on the visual analog pain scale. INTERVENTIONS: A minimum of 5 neurofeedback sessions per week (40min/session) for 8 consecutive weeks was undertaken with a 12-week follow-up baseline electroencephalography recording period. MAIN OUTCOME MEASURES: Primary feasibility outcomes: accessibility, tolerability, safety (adverse events and resolution), and human and information technology (IT) resources required. Secondary outcomes: pain, sensitization, catastrophization, anxiety, depression, sleep, health-related quality of life, electroencephalographic activity, and simple participant feedback. RESULTS: Of the 23 people screened, 11 were eligible for recruitment. One withdrew and another completed insufficient sessions for analysis, which resulted in 9 datasets analyzed. Three participants withdrew from the follow-up baselines, leaving 6 who completed the entire trial protocol. Thirteen adverse events were recorded and resolved: 1 was treatment-related, 4 were equipment-related, and 8 were administrative-related (eg, courier communication issues). The human and IT resources necessary for trial implementation were identified. There were also significant improvements in pain levels, depression, and anxiety. Six of 9 participants perceived minimal improvement or no change in symptoms after the trial, and 5 of 9 participants were satisfied with the treatment received. CONCLUSIONS: It is feasible and safe to conduct a home-based trial of a neurofeedback intervention for people with chronic neuropathic pain, when the human and IT resources are provided and relevant governance processes are followed. Improvements in secondary outcomes merit investigation with a randomized controlled trial.

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