Protocol for a Prospective Cohort Study on Determinants of Outcomes in Lumbar Radiculopathy Surgery
Alejandro Aceituno-Rodríguez1,8*, Carlos Bustamente2, Carmen Rodríguez-Rivera4,6, Miguel Molina-Álvarez5, Carlos Rodríguez-Moro7, Rafael García-Cañas7, Carlos Goicoechea-García4,5,6 and Luis Matesanz-García3,5
1Escuela Internacional de Doctorado, Faculty of Health Sciences, Universidad Rey Juan Carlos, Madrid, Spain
2Hospital Clínico San Carlos, Madrid, España
3CranioSPain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain
4Area of Pharmacology, Nutrition and Bromatology, Department of Basic Health Sciences, Universidad Rey Juan Carlos, Unidad Asociada I+D+i Instituto de Química Médica (IQM) CSIC-URJC, Madrid, Spain
5Cognitive Neuroscience, Pain, and Rehabilitation Research Group (NECODOR), Faculty of Health Sciences, Universidad Rey Juan Carlos, Madrid, Spain
6High Performance Experimental Pharmacology Research Group (PHARMAKOM), Faculty of Health Sciences, Universidad Rey Juan Carlos, Madrid, Spain
7Servicio de Cirugía Ortopédica y Traumatología. Hospital Central de la Defensa “Gómez Ulla”, Madrid, Spain
8Department of Physiotherapy, Faculty of Medicine, Health and Sports, European University of Madrid
*Corresponding Author: Alejandro Aceituno-Rodríguez, Escuela Internacional de Doctorado, Faculty of Health Sciences, Universidad Rey Juan Carlos, Madrid, Spain, Department of Physiotherapy, Faculty of Medicine, Health and Sports, European University of Madrid.
Received:
August 19, 2025; Published: September 16, 2025
Abstract
Introduction: Lumbar radiculopathies involving the entrapment of nerve roots in the lumbar spine are common neuropathic conditions. These conditions affect 40% to 70% of individuals in their lifetime and lead to significant medical costs.
Materials and Methods: This prospective cohort study, conducted at Hospital Central de la Defensa Gómez Ulla, Madrid (Spain), adheres to the STROBE guidelines. The study includes patients aged 18-75 with lumbar radiculopathy, confirmed by clinical diagnosis, imaging, and electromyography (EMG) findings. Exclusion criteria include previous lumbar spine surgeries and systemic diseases. The primary outcome is the Oswestry Low Back Pain Disability Questionnaire. Sample size calculations determined the need for 141 participants, accounting for a 15% dropout rate.
Procedure: Patients will undergo an initial assessment, including EMG tests, sociodemographic and psychological questionnaires, blood sample tests and physical questionnaires. This process will be repeated six months post-intervention, except for the blood sample test, expectations questionnaire, and EMG, which will be performed only once.
Statistical Analyses: Data will be analyzed using Python statsmodels and pandas libraries, employing a multivariate linear regression analysis. Assumptions of linearity, independence, homoscedasticity, normality, and no multicollinearity will be validated. Corrective measures will be applied if assumptions are violated.
Ethics and Dissemination: The study follows the Declaration of Helsinki guidelines and the Ethics Committee of Universidad Rey Juan Carlos has been approved (070220241052024). Potential risks will be minimized, and adverse events will be recorded and addressed. Findings will be published in high-impact journals and presented at conferences
Keywords: Sciatic Nerve; Lumbar Radiculopathy; NFL, Neuropathic Pain
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