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

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-10-31 DOI:10.1016/j.cct.2024.107731

Marco Antonio Morales-Osorio , Robinson Ramirez-Velez , Johana Mejía-Mejía , Laura Aline Martinez-Martinez , Fabian Román , Pedro Javier Lopez-Perez , Leidy Tatiana Ordoñez-Mora

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引用次数: 0

Abstract

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

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疼痛神经科学教育项目在改善纤维肌痛患者执行功能和疼痛强度方面的效果（纤维脑项目）：随机对照临床试验研究方案

背景纤维肌痛（FM）是一种慢性肌肉骨骼疾病，以慢性疼痛、睡眠障碍、慢性疲劳和认知问题为典型特征。本研究旨在探讨疼痛神经科学教育项目（PNE）在改善 FM 患者执行功能和疼痛强度方面的疗效，并将其与标准治疗方案进行比较。方法这项盲法对照临床试验将比较两组患者在执行功能和疼痛强度方面的变化。第一组将接受以 PNE 为辅的标准治疗，包括五个星期的十个疗程，每个疗程持续 40-45 分钟。这种方法的主要目的是重塑对疼痛的认知和情绪反应，挑战疼痛与受伤直接相关的观点，并强调情绪、睡眠和身体活动对疼痛感知的影响。第二组将只接受标准的药物治疗。根据以往证据对样本量的初步估计，研究样本将包括 62 名被诊断患有 FM 的成年人。在对基线特征进行基线评估后，患者将被随机分配到 PNE 组或对照组。5 周后将对干预结果进行评估和统计比较。本方案符合所有相关的伦理准则。该方案已获得两个机构委员会的批准（参考文献：NR2006；Conbioethics:21-CEI-004-20,170,829）：临床试验注册：NCT05084300

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.