- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07765043
Electromagnetic Therapy for Cervicogenic Dysphagia
Efficacy of Electromagnetic Therapy in the Treatment of Cervicogenic Dysphagia: Randomized Single-blind Placebo-Control Study
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Mecca, Саудовская Аравия, 24351
- Umm Al-Qura University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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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Плацебо Компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Swallowing function
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain intensity
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: ASHRAF AM ABDELAAL, Ph.D., Umm Al-Qura University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HAPO-02-K-012-2024-01-1956
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .