- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07626307
Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy (MIGSKA)
Multicenter Interventional Study for the Evaluation of the Performance of the Doraldo-Castelletti Scale in Supporting the Neurologist's Decision to Refer Migraine Patients to Physiotherapy (MIGSKA)
Migraine is the leading cause of disability worldwide among people aged 15 to 49. Although therapies targeting the CGRP pathway have improved the management of the condition, there are large groups of patients who do not respond to medications or for whom these are contraindicated. In this context, non-pharmacological therapies such as physical therapy play a crucial role.
The scientific literature highlights a strong link between migraine and cervical disorders:
- 77% of migraine patients suffer from neck pain.
- 93% have at least three musculoskeletal dysfunctions in the cervical region.
- Patients with cervical symptoms experience more frequent attacks, greater disability, a poorer response to medication, and a higher risk of chronicity.
Despite the proven utility of physical therapy for the prevention and treatment of migraine (as demonstrated by validated physical tests and standardized questionnaires such as the NDI, HDI, and HIT-6), musculoskeletal screening is not routinely included in neurological examinations. Neurologists in headache centers generally lack the time and specific manual skills required to perform a thorough physical assessment of the cervical spine.
There is therefore a lack of a rapid and effective screening tool that serves as a "bridge" between neurology and rehabilitation.
The primary objective of the MIGSKA study is to evaluate the performance of the Doraldo-Castelletti scale in assessing the clinical need and motivation of patients with migraine to undergo physical therapy. The study will also assess the utility of this scale as a decision-making tool for neurologists in referring appropriate patients to physical therapists.
To address this gap in clinical practice, the study analyzes the Doraldo-Castelletti scale. The adoption of this tool aims to:
- Easily identify migraine patients with significant musculoskeletal dysfunction.
- Quantify the patient's attitude and motivation toward manual therapy (a determining factor for treatment success).
- Provide the neurologist with an objective and rapid criterion for prescribing a specialized physical therapy evaluation, promoting a genuine and effective multidisciplinary approach to migraine care.
Обзор исследования
Подробное описание
Migraine is the leading cause of disability worldwide among people aged 15 to 49. Although therapies targeting the CGRP pathway have improved the management of the condition, there are large groups of patients who do not respond to medications or for whom these are contraindicated. In this context, non-pharmacological therapies such as physical therapy play a crucial role.
The scientific literature highlights a strong link between migraine and cervical disorders:
- 77% of migraine patients suffer from neck pain.
- 93% have at least three musculoskeletal dysfunctions in the cervical region.
- Patients with cervical symptoms experience more frequent attacks, greater disability, a poorer response to medication, and a higher risk of chronicity.
Despite the proven utility of physical therapy for the prevention and treatment of migraine (as demonstrated by validated physical tests and standardized questionnaires such as the NDI, HDI, and HIT-6), musculoskeletal screening is not routinely included in neurological examinations. Neurologists in headache centers generally lack the time and specific manual skills required to perform a thorough physical assessment of the cervical spine.
There is therefore a lack of a rapid and effective screening tool that serves as a "bridge" between neurology and rehabilitation.
The primary objective of the MIGSKA study is to evaluate the performance of the Doraldo-Castelletti scale in assessing the clinical need and motivation of patients with migraine to undergo physical therapy. The study will also assess the utility of this scale as a decision-making tool for neurologists in referring appropriate patients to physical therapists.
To address this gap in clinical practice, the study analyzes the Doraldo-Castelletti scale. The adoption of this tool aims to:
- Easily identify migraine patients with significant musculoskeletal dysfunction.
- Quantify the patient's attitude and motivation toward manual therapy (a determining factor for treatment success).
- Provide the neurologist with an objective and rapid criterion for prescribing a specialized physical therapy evaluation, promoting a genuine and effective multidisciplinary approach to migraine care.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Alberto Doretti, MD
- Номер телефона: 2937 +39-0261911
- Электронная почта: a.doretti@auxologico.it
Учебное резервное копирование контактов
- Имя: Luca G Grappiolo
- Номер телефона: 2894 +39-0261911
- Электронная почта: luca.grappiolo@auxologico.it
Места учебы
-
-
-
Milan, Италия, 20149
- Рекрутинг
- Istituto Auxologico Italiano
-
Контакт:
- Alberto Doretti, MD
- Номер телефона: 2937 +39-0261911
- Электронная почта: a.doretti@auxologico.it
-
Контакт:
- Электронная почта: neurotrial@auxologico.it
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age between 18 and 70 years (inclusive)
- Diagnosis of migraine established by a neurologist specialized in headache disorders
- Headache Impact Test (HIT-6) ≥ 42
- Ability to understand the study informed consent
- Signed informed consent
- Ability to comply with the study procedures
Exclusion Criteria:
- Neurological diseases confounding the primary objective
- Conditions confounding the primary objective (e.g., fibromyalgia, which could limit patient evaluation by the physiotherapist)
- Previous physiotherapy treatments specifically for headache management
- Psychiatric disorders confounding and/or interfering with the primary objective
- Unstable psychiatric illness, cognitive impairment, dementia, or substance abuse compromising the participant's ability to provide informed consent, according to the investigator's judgment
- Previous neurosurgical interventions involving the cervical region
- Any condition deemed contraindicating study participation according to the investigator's judgment
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Doraldo Castelletti scale
Migraine patients are the targeted population for administration of the Doraldo-Castelletti scale during a neurological visit
|
During a routine neurological examination, the physician administers the Doraldo-Castelletti scale to the migraine patient.
The scale consists of 10 multiple choice questions.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Score of the Doraldo-Castelletti scale
Временное ограничение: At baseline
|
Scale consisting of 10 multiple choice questions; Minimum score = 0; Maximum score = 13
|
At baseline
|
|
Proportion of patients referred to physiotherapist
Временное ограничение: At baseline
|
Proportion of patients referred to physiotherapist on the basis of the score of the Doraldo-Castelletti scale
|
At baseline
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
- 23C513
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (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. .
Клинические исследования Doraldo-Castelletti scale
-
University of MinnesotaЗавершенный
-
NEUROPHETAjou University Hospital, Suwon, South KoreaЗавершенныйЛегкое когнитивное нарушение (MCI) | Болезнь Альцгеймера (БА)Южная Корея
-
Bodyport Inc.РекрутингБолезнь почек | Терминальная стадия болезни почек (ESRD) | Перитонеальный диализ (ПД)Соединенные Штаты, Канада
-
Bodyport Inc.Duke Clinical Research InstituteЗавершенныйСердечная недостаточностьСоединенные Штаты
-
BDH-Klinik Hessisch OldendorfРекрутингИнсульт | Травматическое повреждение мозга | Неврологическое расстройство | Расстройство сознания | Гипоксически-ишемическая энцефалопатияГермания
-
Ondokuz Mayıs UniversityЗавершенныйМышечная дистрофия Дюшенна (МДД)Турция
-
Yeditepe UniversityЗавершенный
-
University of California, Los AngelesЗавершенныйСердечная недостаточность | ОжирениеСоединенные Штаты
-
Centre hospitalier de l'Université de Montréal...ЗавершенныйКолоректальная аденома | Колоректальный полипКанада
-
Gazi UniversityЗавершенныйСпать | Моторное развитие | Поздний недоношенный ребенокТурция