Can a specific biobehavioral based therapeutic education program lead to changes in pain perception and brain plasticity biomarkers in chronic pain patients? A study protocol for a randomized clinical trial

Abstract

AbstractBackgroundChronic pain conditions are complex multifactorial disorders with physical, psychological, and environmental factors contributing to their onset and persistence. Among these conditions, the role of brain-derived neurotrophic factor (BDNF) and the impact of a specific therapeutic education (TE) on pain management have emerged as important areas of research.ObjectiveThe aim of this study is to investigate the effects of a specific type of therapeutic education on pain levels and BDNF concentrations.MethodsIn this single-blind, randomized clinical trial, patients will be randomly assigned to one of two groups: one group will receive education with TE and the other group will receive education without TE. Assessments will be made at baseline, mid-treatment, post-intervention, and at one and eight months.OutcomesThe expected results of this study will shed light on the role of TE in pain management and provide insight into its effects on BDNF levels. The intervention will also provide an opportunity to biochemically measure the plastic changes, thereby improving our understanding of its effects on brain plasticity.ConclusionThis study aims to determine the applicability of therapeutic education as an effective non-pharmacological intervention for the management of chronic pain. The rigorous scientific methods used ensure that the proposed interventions will be clinically applicable across different health care systems.Strengths and limitations of this studyThe study will use a specifically pain oriented methodological approach that intends to go beyond purely informational pain neuroscience education, aiming for a more useful understanding of pain from patients.Incorporating the salutogenic model in therapeutic education will bring a health focused perspective to the research, potentially enriching its interpretive framework helping future interventions.The proposed use of clear and replicable guidelines such as GREET or TIDieR may help in the practical implementation challenge for clinicians, potentially influencing also the study’s reproducibility.While the study plans to assess psychosocial factors, pain intensity levels, and brain plastic changes due to therapeutic education, this comprehensive approach might pose notable methodological challenges.Given the emerging field of brain plasticity related to therapeutic education in chronic pain patients, the limited existing research may influence the interpretive depth of the study’s findings.Protocol versionIn this first version of the protocol dated July 2023, we are recruiting the sample, which is planned to be completed in approximately two months (September 2023) in order to start the trial in October 2023.