- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03005691
Central Sensitization in Chronic Whiplash Patients
Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. Little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. Metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash.
Until now, there is not any study that show this approach.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients who have suffered whiplash syndrome. By one hand, patients with chronic pain (minimun 8 weeks) and 2 points or more of pain intensity. By the other hand, patiens without pain (2 points or less of pain intensity).
By last, subjects without whiplash syndrome.
Описание
Inclusion Criteria:
- Whiplash syndrome
- Chronic pain
- Age between 18 to 65 years
- 4 months to 2 years after the whiplash syndrome
Exclusion Criteria:
- Neurological disease
- Claustrophobia
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Когорта
- Временные перспективы: Поперечный разрез
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
---|---|
Whiplash-Pain
Subjects with chronic whiplash syndrome and pain.
The inclusion criteria for pain include the presence of daily pain during the previous 8 weeks.
Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale.
The minimum will be 2 points.
Subjects will be recruited between the 4 months until 2 years after the whiplash.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Whiplash-no Pain
Subjects with chronic whiplash syndrome and pain.
The inclusion criteria for pain include the ausence of daily pain during the previous 8 weeks.
Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale.
The maximun will be 2 points.
Subjects will be recruited between the 4 months until 2 years after the whiplash.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Non-injured
Subjects without whiplash syndrome.
The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.
|
Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration. The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
Questionnaires are important to assess the chronic pain and their impact in the quality of life.
For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale.
Also,we will assess the disability after whiplash using the Neck Disability Index.
Conditioned Pain Modulation over the tenar eminence.
The test will be a heat tonic stimulus which evoke a 3-pain intensity.
The conditioning stimulus will be a cold water immersion (12ºC)
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Metabolite concentrations
Временное ограничение: Baseline at 0 min
|
The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
|
Baseline at 0 min
|
Conditioned Pain Modulation
Временное ограничение: Baseline at 0 min
|
Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
|
Baseline at 0 min
|
Brief Pain Inventory
Временное ограничение: Baseline at 0 min
|
Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
|
Baseline at 0 min
|
Neurophatic Pain Symptoms Inventory
Временное ограничение: Baseline at 0 min
|
Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
|
Baseline at 0 min
|
Pain Catastrophizing Helplessness Subscale
Временное ограничение: Baseline at 0 min
|
Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
|
Baseline at 0 min
|
Neck Disability Index
Временное ограничение: Baseline at 0 min
|
Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
|
Baseline at 0 min
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos, Toledo
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
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
- GFSM-HNP
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.
продукт, произведенный в США и экспортированный из США.
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