Клинические исследование Когнитивные нарушения, Опиатная зависимость, Хроническая доброкачественная боль - Реестр клинических исследований

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services.

This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment.

For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce.

A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids.

The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain.

Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects.

The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.

Тип исследования

Наблюдательный

Регистрация (Действительный)

50

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Дания
- - Holbæk, Дания, 4300
    - Holbæk Hospital
  - Køge, Дания, 4600
    - Zealand University Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge

Описание

Inclusion Criteria:

Patients > 18 years of age and able to provide a written consent
Participating in the opioid reduction programme

Exclusion Criteria:

Not able to speak and understand Danish
Patients suffering from dementia or psychosis

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Наблюдательные модели: Когорта
Временные перспективы: Перспективный

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Cognitive function before opioid reduction Временное ограничение: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)	Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)

Вторичные показатели результатов

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Zealand University Hospital

Следователи

Главный следователь: Stine Estrup, MD, Zealand University Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 января 2018 г.

Первичное завершение (Действительный)

3 мая 2019 г.

Завершение исследования (Действительный)

3 мая 2019 г.

Даты регистрации исследования

Первый отправленный

10 января 2017 г.

Впервые представлено, что соответствует критериям контроля качества

25 января 2017 г.

Первый опубликованный (Оценивать)

31 января 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 июля 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 июля 2019 г.

Последняя проверка

1 июля 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

SE-4-2016

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Нет

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. .

Мера результата	Мера Описание	Временное ограничение
Cognitive function at halfway point Временное ограничение: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)	Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
Cognitive function at end of reduction Временное ограничение: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).	When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
Executive function before opioid reduction Временное ограничение: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)	Executive function measured by Trail making test A and B	At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Executive function at halfway point Временное ограничение: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)	Executive function measured by Trail making test A and B	When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
Executive function at end of reduction Временное ограничение: When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Executive function measured by Trail making test A and B	When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
Morphine use before reduction Временное ограничение: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)	Morphine equivalents before reduction	At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
Morphine use after reduction Временное ограничение: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Morphine equivalents after reduction	At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
Use of other analgesics before reduction Временное ограничение: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)	Use of any other analgesic	At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Use of other analgesics at halfway point Временное ограничение: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)	Use of any other analgesic	When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
Use of other analgesics after reduction Временное ограничение: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Use of any other analgesic	At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
Quality of life before reduction Временное ограничение: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)	Quality of life measured by SF36	At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Quality of life at halfway point Временное ограничение: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)	Quality of life measured by SF36	When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
Quality of life at end of reduction Временное ограничение: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Quality of life measured by SF36	At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
Risk of anxiety and depression before reduction Временное ограничение: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)	Risk of anxiety and depression measured by Hospital anxiety and depression scale	At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
Risk of anxiety and depression at halfway point Временное ограничение: When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)	Risk of anxiety and depression measured by Hospital anxiety and depression scale	When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
Risk of anxiety and depression at end of reduction Временное ограничение: At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)	Risk of anxiety and depression measured by Hospital anxiety and depression scale	At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)

Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)

Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study