Electromagnetic Therapy for Cervicogenic Dysphagia
Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Swallowing represents an integrated sensorimotor process accomplished by coordinated muscular actions. Cervical spine structures, under normal conditions, play an important role in maintaining coordinated swallowing.
The muscular and neural structures of the cervical spine are responsible for the coordinated movement of the larynx, pharynx, and hyoid bone during swallowing. Sensory information ascends from cervical structures to the brainstem, providing feedback to help synchronize the complex and harmonized contributions of the neck and throat muscles during swallowing. Disruption of this sensory feedback loop can result in coordination deficits and difficulty swallowing.
Biomechanical alterations or degenerative changes in the cervical spine can affect its position and stability. These alterations may further impact the surrounding neural and muscular structures' functions, resulting in a variety of alarming symptoms and dysfunctional patterns that predispose to mechanical obstruction and difficulty swallowing.
Cervicogenic dysphagia (CD) is an alarming disorder characterized by disturbed swallowing secondary to cervical structures dysfunction. Cervical spondylosis and associated pathological consequences can contribute to the development of CD. Cervical spine biomechanical alterations and malalignments, such as cervical kyphosis, a condition commonly encountered in cervical spondylosis, can predispose to pharyngeal dysfunction and difficult swallowing. The combined effects of neck muscular and articular dysfunctions represented in muscle weakness, poor cervical posture, and limited range of motion can disturb the cricopharyngeal sphincter action and the normal laryngeal function, ultimately predisposing to CD.
Although cure of dysphagia is not always possible, conservative approaches can provide an effective path to alleviate patients' complaints. A comprehensive dysphagia management program is not only important to restore normal swallowing function, but also to eliminate the economic burden and the dysphagia-related health hazards.
Low-frequency, low-intensity electromagnetic field therapy (EMT) is a safe, non-invasive therapeutic modality of clinical interest and effective applicability in the treatment of a variety of pathologies.
Although the effectiveness of pulsed electromagnetic field therapy (PEMFT) as a safe and effective therapeutic modality was investigated in a variety of cervical pathologies, there is a lack of evidence supporting the effectiveness of PEMFT in the treatment of patients with cervicogenic dysphagia.
Considering the reported safety and effectiveness of PEMFT therapy in the treatment of different pathologies, this study aimed to investigate the effects of PEMFT therapy on swallowing function and the dysphagia handicapping effects in patients with CD.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Mecca, Arabia Saudita, 24351
- Umm Al-Qura University
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Individuals diagnosed with cervicogenic dysphagia and cervical spondylosis
- Age 50-60 years.
- Individuals with a sedentary lifestyle (less than 30 minutes of aerobic activities per day).
- Signed the written consent
Exclusion Criteria:
- Subjects diagnosed with rheumatological disease, cerebrovascular abnormalities
- Subjects having a metal implant or previous cervical surgeries.
- Subjects having received physical therapy programs for cervical spondylosis or dysphagia within the last 6 months.
Subjects with recent infection, cognitive impairments or dementia, cardiovascular instability, head or neck traumatic injuries, neurological disorders affecting swallowing (e.g., parkinsonism, stroke).
- Subjects who received medications interfering with normal swallowing function (e.g., antiepileptics, antipsychotics, and antidepressant drugs).
- Subjects who refused to provide the signed informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Study group (received PEMFT + swallowing resistance training program; n=20)
Participants in the study group received the PEMFT treatment program in addition to the swallowing resistance training program "SRTP (which included the resisted chin tuck-in and the resisted swallowing exercises).
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The pulsed electromagnetic field treatment program plus the swallowing resistance training program
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Comparador de placebos: Control group (received placebo PEMFT + swallowing resistance training program; n=20)
Participants in the control (Placebo comparator) group received the placebo PEMFT treatment program in addition to the swallowing resistance training program "SRTP (which included the resisted chin tuck-in and the resisted swallowing exercises).
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The placebo pulsed electromagnetic field treatment program plus the swallowing resistance training program
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Swallowing function
Periodo de tiempo: Baseline and post-8 weeks
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Assessment of the swallowing function using the Swallowing Disturbance Questionnaire, composed of 15 self-reported items.
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Baseline and post-8 weeks
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The dysphagia handicapping effects
Periodo de tiempo: Baseline and post 8 weeks.
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The dysphagia handicapping effects assessment (using Dysphagia Handicap Index)
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Baseline and post 8 weeks.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain intensity
Periodo de tiempo: Baseline and post 8 weeks
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Assessment of pain intensity using the 10 cm visual analog scale (VAS)
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Baseline and post 8 weeks
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The forward head position
Periodo de tiempo: Baseline and post 8 weeks
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The forward head position assessment (the craniovertebral angle)
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Baseline and post 8 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: ASHRAF AM ABDELAAL, Ph.D., Umm Al-Qura University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- HAPO-02-K-012-2024-01-1956
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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