Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol. (FREMS)
Effects Of Frequency Rhythmic Electrical Modulated Stimulation (FREMS) On Blood Perfusion, Neuropathy Severity And Quality Of Life In Diabetic Patients With Peripheral Neuropathy And Lower Limb Ischemia: A Randomized Controlled Trial.
It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence [14], the goal of the study is to investigate this problem through the following objectives:
- To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
- To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.
- To compare the results between both interventional and control group.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There are no clear guidelines for the treatment of peripheral neuropathy. While the American Diabetes Association stresses the importance of early detection and preventive measures, diagnosis and management are still on a developing path.
drugs used have common side effects; duloxetine and pregabalin patients are prone to nausea, fatigue, constipation, and decreased appetite; antidepressants may cause drowsiness, dry mouth, and muscle weakness; and opioids are prevented for long-term use due to the risk of addiction in all chronic cases like peripheral neuropathy. And most of the studies on these medications didn't report quality of life effects.
the lack of clear safe treatments with long-term effects on function and quality of life is the motive to conduct a randomized controlled trial on an objective assessment tool like duplex and a valid and reliable diagnostic tool like the neuropathy impairment score(NIS), measuring the effect of treatment on quality of life by the NORFOLK quality of life questionnaire after treatment with safe nonpharmacological treatment like FREMS therapy.
cases will be referred to the physiotherapy department by a diagnosis of peripheral neuropathy. samples will be assessed and divided into two groups randomly, Group A that will conduct a session with APTIVA FREMS therapy. Group B that will follow the conservative used treatment (doulextine and vitamin supplements) only.
The Number of sessions is 10 sessions consecutively within 10:14 days. The patients will be assessed by full neurological examination through the duplex APSV, neuropathy impairment score and NORFOLK quality of life questionnaire before and after the treatment.
outcomes will be collected by the researcher.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ibtihal Nassar, Bsc, Msc.
- Número de teléfono: +201151678506
- Correo electrónico: scholaribtihal@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ibtihal Nassar
- Número de teléfono: 01151678506
- Correo electrónico: scholaribtihal@gmail.com
Ubicaciones de estudio
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Giza, Egipto
- National diabetes institute
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Contacto:
- Ibtihal Nassar, Bsc, Msc.
- Número de teléfono: +201151678506
- Correo electrónico: scholaribtihal@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- patients diagnosed with DM
- patients age group above 40 years old.
- patient diagnosed with peripheral neuropathy with symptoms lasts more than 3 months.
- patients lower limb ischemia in duplex affected APSV.
Exclusion Criteria:
- patients with implant peacemakers, defibrillator, or neurostimulator.
- pregnancy.
- any severe disease prevent compliance to study procedures.
- patients with disabilities prevent their commitment to sessions.
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 |
|---|---|
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Experimental: (FREMS group)
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FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.
Otros nombres:
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Comparador activo: conservative treatment.
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peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neuropathy severity
Periodo de tiempo: From enrollment to the end of treatment at 10:14 days
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neuropathy symptoms like (tingling, numbness, pain, loss of sensation) will be measured through neuropathy impairment score(NIS)
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From enrollment to the end of treatment at 10:14 days
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blood perfusion.
Periodo de tiempo: From enrollment to the end of treatment at 10:14days.
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effect of FREMS on blood perfusion by duplex.
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From enrollment to the end of treatment at 10:14days.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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neuropathy effect in quality of life
Periodo de tiempo: From enrollment to the end of treatment at 10:14days.
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neuropathy effect on quality of life by NORFOLK quality of life questionnaire.
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From enrollment to the end of treatment at 10:14days.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ayman abdallah., phd, Beni-Suef University
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- FPTBSUREC/0113/14526
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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