High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)
28 de enero de 2021 actualizado por: Moens Maarten, Universitair Ziekenhuis Brussel
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain.
Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Tipo de estudio
De observación
Inscripción (Actual)
272
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Brussel, Bélgica
- UZ Brussel
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Descripción
Inclusion Criteria:
- Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- Age > 18 years
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol including attending the study visits
Exclusion Criteria:
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (HIV positive, immunosuppressiva, etc.)
- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain intensity with the Numeric Rating Scale (NRS)
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Pain relief by pain medication
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the amount of pain relief by pain medication
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The abilities in daily living
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The current health status
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain area coverage
Periodo de tiempo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The patient has to draw the areas of pain coverage on a body shape figure
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Paresthesia threshold
Periodo de tiempo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient indicates the threshold at which he experiences paresthesia
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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HD stim parameters
Periodo de tiempo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire towards the clinician regarding the ideal high density parameters for this patient
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Battery efficiency of the neurostimulator
Periodo de tiempo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The battery usage will be measured by frequencies to recharge the battery.
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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AdaptiveStim use (in case of Restore Sensor)
Periodo de tiempo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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MRI need
Periodo de tiempo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the need for MR scans for other medical conditions
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
- Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
- Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
- Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2016
Finalización primaria (Actual)
8 de diciembre de 2020
Finalización del estudio (Actual)
8 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
26 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2016
Publicado por primera vez (Estimar)
1 de junio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
28 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Discover1
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