Реакция на нестероидные противовоспалительные препараты (НПВП) и центральная сенсибилизация боли у женщин с дисменореей
Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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Massachusetts
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Belmont, Massachusetts, Соединенные Штаты, 02478
- McLean Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Female aged 18-50 years
- Menstrual pain rated at least 6/10 on a 0 (no pain) to 10 (worst pain possible) NRS for all menstrual cycles in the previous 6 months
- Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
- Self-reported menstrual cycle averaging 22-35 days
- Access to a smartphone and email, and willing/able to receive text messages
- Able to read and understand English
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
- Variable levels of menstrual pain in the previous 6 months
- Self-reported symptoms consistent with a chronic pain condition (e.g., pain in any body area lasting longer than 3 months) or previous diagnosis of a chronic pain condition
- Currently pregnant or breastfeeding
- History of pelvic inflammatory disease or sexually transmitted disease
- Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease)
- Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease)
- History of high blood pressure or anemia (due to possible complications from NSAID use).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Sodium Naproxen first
Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle. |
One dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). One dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). |
|
Экспериментальный: Placebo first
Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle. |
One dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). One dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response
Временное ограничение: 4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant
|
NSAID response will be calculated by comparing change in menstrual pain ratings following NSAID to change in menstrual pain ratings following placebo. Calculated by subtracting the placebo cycle response measure from the NSAID cycle response measure. This will result in a single measure indicative of the degree of NSAID response, while controlling for placebo effects. Possible range: -20 (min) to 20 (max). The value of each intervention separately can be associated with a better or worse outcome, as indicated below. The value of this measure is not independently clinically meaningful (i.e., not related to better or worse outcomes) as it is the result of comparing an individual to themself. Negative values indicate that the participant demonstrated more response to naproxen than they did to placebo; positive values indicate that the participant demonstrated more response to placebo than they did to naproxen. |
4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant
|
|
Urinary Naproxen Concentration
Временное ограничение: Four hours after taking the dose (either Naproxen or placebo).
|
Concentration of naproxen measured in the urine sample. Measured in nanograms of Naproxen Glucuronide per mg creatinine. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes). |
Four hours after taking the dose (either Naproxen or placebo).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Placebo Cycle Response
Временное ограничение: 4 hours after dose is taken.
|
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome. |
4 hours after dose is taken.
|
|
Non-steroidal Anti-inflammatory Drug (NSAID) Cycle Response
Временное ограничение: 4 hours after dose is taken.
|
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome. |
4 hours after dose is taken.
|
|
Urinary PGF2α Concentration
Временное ограничение: Four hours after taking the dose (either Naproxen or placebo).
|
Concentration of prostaglandin F2α (PGF2α) measured in the urine sample. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes). |
Four hours after taking the dose (either Naproxen or placebo).
|
|
Urinary PGE Concentration
Временное ограничение: Four hours after taking the dose (either Naproxen or placebo).
|
New information since initial submission indicated that this outcome measure (Prostaglandin E; PGE) would not be detectable in urine. No PGE analyses were conducted. |
Four hours after taking the dose (either Naproxen or placebo).
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Laura Payne, PhD, Mclean Hospital
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
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Патологические процессы
- Боль в области таза
- Нарушения менструации
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Дисменорея
- Органические химические вещества
- Углеводороды
- Углеводороды, циклические
- Нафталины
- Полициклические ароматические углеводороды
- Углеводороды, ароматные
- Полициклические соединения
- Нафталиоковые кислоты
- Напроксен
Другие идентификационные номера исследования
- 2023P001489
Планирование данных отдельных участников (IPD)
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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.
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. .