Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol

• Published in: PloS one Vol. 18; no. 8; p. e0290096
• Main Authors: Fernández-Gualda, Miguel Ángel, Ariza-Vega, Patrocinio, Lozano-Lozano, Mario, Cantarero-Villanueva, Irene, Martín-Martín, Lydia, Castro-Martín, Eduardo, Arroyo-Morales, Manuel, Tovar-Martín, Isabel, Lopez-Garzon, Maria, Postigo-Martin, Paula, González-Santos, Ángela, Artacho-Cordón, Francisco, Ortiz-Comino, Lucía, Galiano-Castillo, Noelia, Fernández-Lao, Carolina
• Format: Journal Article
• Language: English
• Published: San Francisco Public Library of Science 15.08.2023; Public Library of Science (PLoS)
• Subjects: Applications programs; Biology and Life Sciences; Breast cancer; Cancer; Cancer therapies; Care and treatment; Central nervous system; Chemotherapy; Clinical trials; Complications; Complications and side effects; Computer and Information Sciences; Education; Engineering and Technology; Exercise; Health services; Intervention; Manipulative therapy; Medical diagnosis; Medical research; Medicine and Health Sciences; Medicine, Experimental; Mobile computing; Nervous system; Neurophysiology; Neurosciences; Pain; Pain management; Patient outcomes; Patients; Physical therapy; Quality of life; Radiation therapy; Range of motion; Rehabilitation; Statistical power; Study Protocol; Spain; Canada
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0290096

Introduction Pain is one of the most persistent symptoms after cancer treatment. The central nervous system can erroneously stay in its alarm phase, altering the pain experience of patients who have cancer. Pain neuroscience education (PNE) with multimodal approaches may benefit these patients. Objective This protocol aims to determine the effectiveness of a PNE tool on pain, physical function and quality of life, as a supplement to a multimodal rehabilitation (MR) program in patients who had breast cancer (BC). Methods An 8-week double-blinded randomized controlled trial will be conducted, including 72 participants who had BC and who have persistent pain, randomized into three groups: PNE program + MR program, traditional biomedical information + MR program and control group. The PNE program will include educational content that participants will learn through a mobile app and the MR program will include a concurrent exercise program and manual therapy. The primary outcome will be the perceived pain assessed using the Visual Analogue Scale and secondary outcomes are others related to pain, physical function and quality of life. All outcomes will be evaluated at baseline, at the end of the intervention and 6 months after the end of intervention. Discussion The proposed study may help BC patients with persistent pain improve their pain experience, quality of life and provide for more adaptive pain-coping strategies. This protocol could propose an action guide to implement different integral approaches for the treatment of sequelae. This treatment option could be offered to this patient profile and it could be easily implemented in the healthcare systems due to its low costs. Trial registration ClinicalTrials.gov, NCT04877860. (February18, 2022).