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- Ensayo clínico NCT01966250
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery: a Study Protocol for a Pilot Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gyeongsangnamdo
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Yangsan, Gyeongsangnamdo, Corea, república de, 626-770
- Pusan National University Korean Medicine Hospital
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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:
- Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
- Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
- Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
- Patients who are 19 - 70 years of age.
- Patients who agreed to voluntarily participate in this study and signed informed consent.
Exclusion Criteria:
- Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
- Patients with progressive neurological deficit or severe neurological symptoms.
- Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
- Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
- Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
- Patients who are currently pregnant or planning the pregnancy.
- Patients with psychiatric diseases.
- Patients who are participating in other clinical trial.
- Patients who are unable to sign informed consent.
- Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Electroacupuncture and Usual care
15 minutes of electroacupuncture and usual care.
Usual care contains 15 minutes ICT(Interferential Current Therapy), 10 minutes hot pack or ice pack and education of patients.
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Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes. Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated. |
Comparador activo: usual care
15 minutes ICT, 10 minutes hot pack or ice pack and education of patients
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Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks.
ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes.
Doctors will educate patient physiology, pathology, and epidemiology of low back pain.
And also suitable postures and exercises for low back pain will be educated.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Visual Analogue Scale
Periodo de tiempo: up to 4 months
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up to 4 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Oswestry Disability Index
Periodo de tiempo: up to 4 months
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up to 4 months
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EuroQoL 5-Dimension Questionnaire
Periodo de tiempo: up to 4 months
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up to 4 months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Byung-cheul Shin, Pusan National University Korean Medicine Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Heo I, Hwang MS, Hwang EH, Cho JH, Ha IH, Shin KM, Lee JH, Kim NK, Son DW, Shin BC. Electroacupuncture as a complement to usual care for patients with non-acute low back pain after back surgery: a pilot randomised controlled trial. BMJ Open. 2018 May 17;8(5):e018464. doi: 10.1136/bmjopen-2017-018464.
- Hwang MS, Heo KH, Cho HW, Shin BC, Lee HY, Heo I, Kim NK, Choi BK, Son DW, Hwang EH. Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial. BMJ Open. 2015 Feb 4;5(2):e007031. doi: 10.1136/bmjopen-2014-007031.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- 2013012
- K13273 (Otro número de subvención/financiamiento: Korea Institute of Oriental Medicine)
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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