Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial

Background: Fibromyalgia (FM) is a chronic musculoskeletal condition typically characterized by chronic pain, sleep disturbances, chronic fatigue, and cognitive problems. The present study aims to examine the efficacy of a pain neuroscience education program (PNE) in improving executive functions and pain intensity in patients with FM and compare them with those of standard treatment protocols. Methods: This blinded, controlled clinical trial will compare changes in executive function and pain intensity between two groups. The first group will receive standard treatment supplemented with PNE, consisting of ten sessions spread over five weeks, with each session lasting 40-45 min. The main objective of this method is to remodel cognitive and emotional reactions to pain, challenging the idea that pain is directly related to injury and highlighting the influence of emotions, sleep, and physical activity on pain perception. The second group will receive only standard pharmacological treatment. The study sample will include 62 adults diagnosed with FM, according to initial sample size estimates based on previous evidence. A baseline assessment of baseline characteristics will be performed, after which patients will be randomly assigned to the PNE group or the control group. The results of the intervention will be evaluated and statistically compared after 5 weeks. This protocol complies with all relevant ethical guidelines. It has been approved by two institutional committees (Reference: NR2006; Conbioethics:21-CEI-004-20,170,829). Conclusion: It is anticipated that this intervention will be a cost-effective and superior alternative to standard treatments. Clinical trial registration: NCT05084300