Dolor Neuropático Crónico Grave: Un Paquete de Tratamiento, Utilizando Estimulación de la Médula Espinal y Tratamiento Multidisciplinario, para Reducir el Dolor y Mejorar la Función Física. (SCS-R)
Optimización del Tratamiento para el Dolor Neuropático Crónico: Un Diseño Experimental de Caso Único Replicado Evaluando un Paquete de Tratamiento que Consiste en Rehabilitación Multidisciplinaria y Estimulación de la Médula Espinal (SCS-R)
Las personas con daño nervioso pueden desarrollar dolor neuropático. El dolor a veces puede ser intenso e impredecible, causando sensaciones extrañas o alarmantes, por ejemplo, sensaciones de descarga eléctrica o relámpago en el área servida por el nervio dañado.
Examinaremos un tratamiento para el dolor neuropático en las piernas causado por daño nervioso, que puede ocurrir después de una hernia discal o una fractura ósea, con o sin cirugía.
Investigaciones previas sugieren que la estimulación de la médula espinal puede aliviar el dolor neuropático en las piernas después de una cirugía o lesión, pero su efectividad aún se debate. Otros estudios muestran que el tratamiento multidisciplinario ayuda a las personas con dolor crónico a mejorar su calidad de vida y a afrontar mejor la vida. Las guías nacionales e internacionales recomiendan este tipo de atención multidisciplinaria para el dolor crónico.
Nadie ha publicado aún investigaciones sobre la estimulación de la médula espinal combinada con tratamiento multidisciplinario como una intervención integral. Por lo tanto, queremos averiguar si este enfoque combinado puede reducir el dolor neuropático en las piernas y mejorar el funcionamiento físico.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Single-case experimental design (SCED) with repeated measurements structured into phases is the method of this study.
Phase A1 is the pre-implantation baseline, Phase A2 is waiting time from implantation to start of the intervention (SCS+rehabilitation). Length of A2 is randomized (2-4 weeks).
Phase B is the active SCS+rehabilitation intervention and lasts for 12 weeks (for analysis split into an early B1 (week 1-5) and a later B2 period (week 8-12), and FU is the 5 week follow-up approximately 6 months after implantation.
Outcomes are measured repeatedly within these phases, allowing within-patient phase contrasts.
In general, baseline (A1) is compared with the intervention periods (B1 and B2) and with follow-up (FU). The main pre-specified contrasts for the primary outcomes are:
- For leg pain intensity A1 vs B1 is the primary comparison and A1 vs B2 is secondary, with A1 vs FU and B2 vs FU reported descriptively.
- For physical function (PROMIS-29), A1 vs B2 is the primary comparison as onset of rehabilitation effect is expected to be delayed. A1 vs B1 is exploratory, with A1 vs FU and B2 vs FU reported descriptively.
Other repeated-measures outcomes (PROMIS-29 domains and additional NRS/physical activity measures) follow the same structure, with A1 vs B2 generally defined as secondary and A1 vs FU descriptive as shown in the statistical tables
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christopher Ekholdt, PhD-student
- Número de teléfono: +4723026161
- Correo electrónico: chrekh@ous-hf.no
Copia de seguridad de contactos de estudio
- Nombre: Lars-Petter Granan, Ph.D
- Número de teléfono: +4723026161
- Correo electrónico: largra@ous-hf.no
Ubicaciones de estudio
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Oslo, Noruega
- Reclutamiento
- Department of pain management and research, Oslo university hospital
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Contacto:
- Lars-Petter Granan, Ph.D
- Número de teléfono: +4723026161
- Correo electrónico: largra@ous-hf.no
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Contacto:
- Christopher Ekholdt, Ph.D-student
- Número de teléfono: +4723026161
- Correo electrónico: chrekh@ous-hf.no
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
Dolor neuropático periférico en una o ambas piernas durante >6 meses debido a:
- (1) Síndrome de dolor posespinal (tipo 1 o 2).
- (2) Daño nervioso localizado.
- El área del dolor neuropático en la(s) pierna(s) debe ser el componente de dolor dominante.
- Edad comprendida entre 18 y 60 años.
- Tratamiento conservador estándar (o quirúrgico) previo intentado.
- Uso de opioides dentro de los límites permisibles en el momento del implante (dosis diaria de opioides <50 mg OMEQ).
- Disposición a participar activamente en el paquete de tratamiento.
- Vivir a una distancia razonable de viaje desde Oslo.
- Competencia en la comprensión oral y escrita del noruego, esencial para beneficiarse del programa que se basa en la comprensión mutua, la conversación matizada y la expresión emocional, que dependen del idioma.
- Capacidad cognitiva para dar el consentimiento informado.
- Capacidad para dominar los aspectos técnicos del sistema de ECS (cambiar programas en el control remoto).
Criterios de exclusión:
- Actualmente en proceso de reclamación de prestaciones de salud (por ejemplo, pensiones por discapacidad de NAV (Administración Noruega del Trabajo y el Bienestar).
- Presentar un trastorno psicológico o psiquiátrico que pueda afectar la eficacia del tratamiento.
- Condiciones de dolor crónico generalizado.
- Otras condiciones de dolor en el área afectada, como osteoartritis.
- Embarazo.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Paquete de tratamiento
Paquete de tratamiento que consiste en estimulación de la médula espinal más rehabilitación multidisciplinar
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La intervención es un paquete de tratamiento que consiste en estimulación de la médula espinal más rehabilitación multidisciplinaria.
La rehabilitación multidisciplinaria consiste en terapia de ejercicio, terapia cognitiva y programación individualizada del dispositivo SCS.
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 in leg(s)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for leg pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) . |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical function (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Physical Function domain T-score (mean 50, SD 10 in the reference population).
Higher scores indicate better physical function.
MCID: increase of ≥5 T-score points.
Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity in the lower back
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for lower back pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Pain interference (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Pain Interference domain T-score. Higher scores indicate more interference of pain with daily activities. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Pain intensity (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for pain intensity last 7 days in PROMIS-29, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Assessed at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical function (6-min-walk test)
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Functional walking capacity is assessed using the Six-Minute Walk Test (6MWT). Distance walked in 6 minutes on a flat course is recorded in meters; higher distances indicate better walking capacity. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical function (sit-to-stand test)
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Lower limb functional strength and endurance are assessed with a Sit-to-Stand Test, recorded as number of repetitions in a fixed time.
More repetitions indicate better performance.
Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
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Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical function (stair test)
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Functional mobility is assessed using a Stair test (ST; time to climb 18 stairs 3 times; lower times indicate better function). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical activity (MET-minutes per week)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical activity is assessed as metabolic equivalent (MET) minutes per week, calculated from reported frequency and duration of activities (International Physical Activity Questionnaire (IPAQ)). Higher values indicate greater weekly physical activity. Assessed once per week during baseline (A1), SCS+rehabilitation (B1/B2), and follow-up (FU) within the single-case experimental design. |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Health-related quality of life (EQ-5D index)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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EQ-5D-5L index score (range 0-1; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Health-related quality of life (EQ-5D-5L VAS)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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EQ-5D Visual Analogue Scale (EQ-5D VAS; 0-100; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Depression symptoms (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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PROMIS Depression scale (T-score; mean 50, SD 10 in U.S. population; higher scores indicate greater symptom severity).
Improvement is defined as a decrease of ≥5 T-score points (MCID).
Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Social participation (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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PROMIS Ability to Participate in Social Roles and Activities short form, reported as a T-score (higher scores indicate better function). MCID: increase of ≥5 T-score points. Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Fatigue (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Fatigue domain T-score. Higher scores indicate greater fatigue. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Sleep disturbance (PROMIS-29)
Periodo de tiempo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Sleep Disturbance domain T-score. Higher scores indicate more sleep problems. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Opioid and Analgesic Use
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Total opioid consumption quantified as milligrams of oral morphine equivalents (OMEQ) per day; non-opioid analgesics quantified in milligrams per day per medication. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Return to work
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Return to work status, quantified as hours worked per week (higher values indicate greater work participation). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Fear of movement (Tampa Scale)
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Fear of movement is assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement. Improvement is defined as a decrease of >6 points. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient-specific functioning
Periodo de tiempo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient-Specific Functional Scale (PSFS), up to five activities selected in cooperation with personnel, rated 0-10 (higher scores indicate better function; average score reported). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient satisfaction
Periodo de tiempo: End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").
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End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lars-Petter Granan, Ph.D, Department of pain management and research, Oslo university hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Neuralgia
- Terapéutica
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia de estimulación eléctrica
- Terapia cognitiva conductual
- Terapia de aceptación y compromiso
- Rehabilitación
- Modalidades de fisioterapia
- Estimulación de la médula espinal
Otros números de identificación del estudio
- 942321
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Los datos individuales de los participantes para todas las variables recopiladas, generados durante el estudio y documentados completamente en un diccionario de datos adjunto (que detalla los nombres de las variables, códigos, valores, unidades y derivaciones), estarán disponibles previa solicitud razonable de investigadores cualificados después de la publicación. El acceso estará restringido a investigadores cualificados que presenten una solicitud y obtengan la aprobación del comité de ética pertinente y de la autoridad de protección de datos.
Los identificadores directos e indirectos, incluidos nombres, fechas exactas y otros riesgos de reidentificación, se eliminarán o transformarán sistemáticamente (como el ajuste de índices de fechas para conservar intervalos y evitar la vinculación), garantizando que el conjunto de datos respalde análisis secundarios sólidos y mantenga la privacidad de los participantes.
Está previsto publicar el protocolo del estudio.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .