Research design considerations for randomized controlled trials of spinal cord stimulation for pain: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials/Institute of Neuromodulation/International Neuromodulation Society recommendations

La estimulación de la médula espinal (SCS, por sus siglas en inglés) es un tratamiento intervencionista no farmacológico que se utiliza para el dolor crónico y otras indicaciones. Los métodos de revisión narrativa que evalúan la seguridad y eficacia de las SCS han evolucionado desde estudios retrospectivos y no controlados hasta ensayos controlados aleatorios (RCTs) prospectivos. Aunque la aleatorización supera ciertos tipos de sesgo, los desafíos adicionales a la validez de los RCTs de SCS incluyen el cegamiento, la elección de los grupos de control, los efectos no específicos de las variables del tratamiento (p. ej., parestesia, programación y recarga de dispositivos, apoyo psicológico y técnicas de rehabilitación) y las consideraciones de seguridad. Para abordar estos desafíos, tres sociedades profesionales (Iniciativa sobre métodos, medición y evaluación del dolor en ensayos clínicos, Instituto de Neuromodulación y Sociedad Internacional de Neuromodulación) convocaron una reunión para desarrollar recomendaciones consensuadas sobre el diseño, realización, análisis e interpretación de RCTs de SCS para el dolor crónico. Este artículo resume los resultados de esta reunión. Los aspectos más destacados de nuestras recomendaciones incluyen la divulgación de todas las fuentes de financiación y los posibles conflictos; incorporar objetivos mecanicistas cuando sea posible; evitar diseños de no inferioridad sin demostración interna de la sensibilidad del ensayo; lograr y documentar el doble ciego siempre que sea posible; documentar la experiencia del investigador y del sitio; mantener equilibrada toda la información proporcionada a los pacientes con respecto a las expectativas de beneficio; divulgar toda la información proporcionada a los pacientes, incluidos los guiones verbales; utilizar controles placebo/simulados cuando sea posible; capturar un conjunto completo de evaluaciones de resultados; tener en cuenta los tratamientos farmacológicos y no farmacológicos auxiliares de manera clara; proporcionar una descripción completa de las interacciones de programación previstas y reales; realizar una verificación prospectiva de los resultados de seguridad específicos de SCS; capacitar a pacientes e investigadores sobre expectativas apropiadas, evaluaciones de resultados y otros aspectos clave del desempeño del estudio; y proporcionar informes transparentes y completos de los resultados de acuerdo con las directrices de presentación de informes aplicables.

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