- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04050254
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Fibromyalgia Patients. A Triple-blinded, Randomized, Placebo-controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why its therapeutic approach is refractory to current treatments.
Based on the theory that fibromyalgia is characterized by a sensitization at the level of the central nervous system that leads to an increase in the perception of pain, any therapeutic approach aimed at modulating the central nervous system may be beneficial. Electrical stimulation with transcranial direct current (tDCS) is among these techniques.
In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect on pain in different chronic pathologies.
The present study aims to investigate the effect on pain of a combination therapy of tDCS and therapeutic exercise in patients with fibromyalgia.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Toledo
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Talavera De La Reina, Toledo, España, 45600
- Hospital General Nuestra Señora del Prado
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Normal pain intensity of 4 or more points on a visual analog scale.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Metallic implants in the head.
- Tumor, trauma or surgery in the brain.
- Epilepsy or stroke.
- History of substance abuse in the last 6 months.
- Use of carbamazepine in the last 6 months.
- Severe depression (Beck Depression Index II of 29 or more).
- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
- Coexisting autoimmune pathology.
- Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control
Sin tratamiento.
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Experimental: Real tDCS + exercise
Transcranial direct current stimulation combined with therapeutic exercise
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Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
|
Comparador falso: Sham tDCS + exercise
Sham transcranial direct current stimulation combined with therapeutic exercise
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The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days.
The program will include exercises and will last 30-45 minutes.
Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.
Sham tDCS will be applied for the same time than real tDCS.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in referred pain area after suprathreshold pressure stimulation from baseline to post-treatment
Periodo de tiempo: Baseline; immediately after intervention; 1-month after intervention
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A pressure algometer (Force Ten™, Wagner Instruments, USA) will be used. It will be performed on the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) at a constant suprathreshold pressure (20% above the pressure pain threshold) for 60 seconds. After the stimulation, the subject should draw the induced pain area on a digital bodychart using the Navigate Pain application (Navigate Pain, Aalborg University, Denmark). |
Baseline; immediately after intervention; 1-month after intervention
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Change in pain intensity from baseline to post-treatment
Periodo de tiempo: Baseline; immediately after intervention; 1-month after intervention
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It will be measured with a visual analog scale (VAS) of 100 millimeters in length.
The subject has to indicate the level of pain he feels, being 0 the absence of pain and 100 the maximum imaginable
|
Baseline; immediately after intervention; 1-month after intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Impacto de la fibromialgia en la calidad de vida
Periodo de tiempo: Base; inmediatamente después de la intervención; 1 mes después de la intervención
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Se medirá con la versión adaptada al español del Fibromyalgia Impact Questionnaire (FIQ).
La escala va de 0 a 100.
Los valores más altos representan un peor resultado.
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Base; inmediatamente después de la intervención; 1 mes después de la intervención
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Anxiety
Periodo de tiempo: Baseline; immediately after intervention; 1-month after intervention
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The version adapted to Spanish from the State Scale (STAI-ES) of the State-Trait Anxiety Inventory (STAI) will be used.
The scale ranges from 0 to 60. Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Pain catastrophizing
Periodo de tiempo: Baseline; immediately after intervention; 1-month after intervention
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The Spanish version of the Pain Catastrophizing Scale (PCS) will be used.
The scale ranges from 0 to 52.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Depression
Periodo de tiempo: Baseline; immediately after intervention; 1-month after intervention
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The adaptation to the Spanish of Beck Depression Inventory II will be used.
The scale ranges from 0 to 63.
Higher values represent a worse result.
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Baseline; immediately after intervention; 1-month after intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Blinding
Periodo de tiempo: Immediately after intervention
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Blinding of subjects and researchers will be assessed using the James Index.
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Immediately after intervention
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- tDCS+ET-Fibromyalgia
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. .
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