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Terapia de alta potencia sonora frente a estimulación nerviosa transcutánea eléctrica en el dolor por polineuropatía en pacientes diabéticos 60

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06822218 es un estudio intervencionista para Diabetes mellitus. Su estado actual es: reclutando. El estudio se inició el 1 de enero de 2023, con el objetivo de reclutar a 60 participantes. Dirigido por la Universidad de El Cairo, se espera que finalice el 28 de febrero de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 12 de febrero de 2025.
Resumen
the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition,...Mostrar más
Descripción detallada
This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be intr...Mostrar más
Título oficial

High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients

Condiciones médicas
Diabetes mellitus
Otros ID del estudio
  • P.T/REC/012/003905
Número del NCT
NCT06822218
Inicio del estudio (real)
2023-01-01
Última actualización
2025-02-12
Fecha de finalización (estimada)
2025-02-28
Inscripción (prevista)
60
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalHigh tone power therapy
30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy
high tone power therapy
patients will be assigned into 2 groups with pre and post treatment protocol application. all patients will be thoroughly evaluated before and after treatment protocol application.
Comparador activoTENS
30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS
TENS
These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention in addition to medications.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.
up to 12 weeks
Pain pressure threshold algometer
devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure
up to 12 weeks
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Glyclated Haemoglobin Level (HbA1c)
Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN
up to 12 weeks
life disability
the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) is an abbreviated, 26-item version of the 100-item WHOQOL-100 quality of life measure. The WHOQOL-BREF addresses four quality of life domains: physical health, psychological health, social relationships and environment. Then calculate a domain score for each of the health domains by calculating the average answer points for each domain (sum of answer points divided by number of questions) and multiplying the result by the number 4.
up to 12 weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
50 Years
Criterios de sexo
Hombre

  • The patient selection will be according to the following criteria:

    1. Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
    2. All patients are ambulant independently.
    3. All patients are under full medical control
    4. HbA1c is ranged from 6.5 : 7 %.
    5. Patients has diabetes more than 10 years.

  • The participants will be excluded if they meet one of the following criteria:

    1. Psychiatric disorders or seizures.
    2. Visual and auditory impairment or tremors influencing balance.
    3. Other neuromuscular disorders.
    4. Foot deformities and ulcers.
    5. Lower limb operations.
    6. Feverish systemic infection
    7. cardiac pacemaker.
Cairo University logoUniversidad de El Cairo1117 estudios activos para explorar
Parte responsable del estudio
Zeinab Mahmoud Awad Allah, Investigador principal, senior of physiotherapy, Cairo University
Contactos centrales del estudio
Contacto: zeinab Awadallah, master, +201285819342, [email protected]
Contacto: Alaa El-Moatasem, lecturer, 01006625054, [email protected]
1 Centros del estudio en 1 países
Om Elmasryeen Genral Hospital, Giza, Egypt
zeinab Awadallah, Contacto, +201285819342, [email protected]
Reclutando