NEUROCANTRIAL: Study protocol for a randomised controlled trial of a pain neuroscience education programme in adults with cancer pain

Abstract

Introduction Pain is the second most frequent symptom reported in patients with cancer among the main reasons for consultation. The incorporation of educational modalities in pain intervention processes has been suggested. This study aims to examine the efficacy of neuroscience pain education (PNE) in relation to pain, biopsychosocial variables and functional capacity in comparison with conventional treatment. It is hypothesised that an intervention based on PNE achieves better outcomes than conventional management, in terms of pain, biopsychosocial variables and functional capacity in adults with oncological pain. Methods and analysis This will be a single-blind, controlled clinical trial in which two groups will be compared using changes in pain as the primary measure. The first group will receive conventional treatment in addition to PNE, and participants will undergo an intervention of nine sessions (one session per week, for a total of 9 weeks), each lasting 30-40 min. Specifically, these sessions will teach biophysiological elements using metaphors that allow the adoption of these concepts related to pain. The second group will receive conventional treatment (pharmacological treatment). For this study, a sample size calculation was made based on the background, where 80 adults with oncological pain were required. An initial evaluation will be made to establish the baseline characteristics, and then, according to the randomisation, the assignment to the PNE group or the control group will be made and the two groups will be summoned again. Ten weeks later, for the intervention evaluation, the statistical analysis plan will be established by protocol and by intention-to-treat. Ethics and dissemination This protocol complies with all ethical considerations. The authors commit to presenting the study's results. This study was approved by the ethics committees of the Universidad Santiago de Cali, Clínica de Occidente/Angiografía de Occidente. The authors commit to presenting the study's results. Trial registration number NCT05581784.