- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01779544
Rehabilitation After Lumbar Disc Surgery: Exercise Therapy and Brief Educational Intervention
Rehabilitation After Lumbar Surgery
Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.
The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.
In this study the following hypothesis will be studied:
- Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
- Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Hordaland
-
Bergen, Hordaland, Норвегия
- Haukeland University Hospital, Ortopedisk klinikk, Kysthospitalet i Hagevik
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosed with lumbar disc prolapse with radicular pain
- Age between 18 and 60
Exclusion Criteria:
- Previous lumbar disc surgery (prolapse)
- Spondyloarthritis
- Arthritis
- Systematic disease
- Heart disease
- Does not understand Norwegian language, spoken or in writing
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Brief intervention only
Brief intervention, an educational model, consists of information
|
The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
|
|
Активный компаратор: Exercise group
Brief educational intervention combined with exercise therapy
|
The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Disability and beliefs about the condition
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Change from baseline in anticipation to return to work at 6-8 weeks postsurgery
Временное ограничение: Baseline and 6-8 weeks postsurgery postsurgery
|
Baseline and 6-8 weeks postsurgery postsurgery
|
|
Change from baseline in health condition at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery
Временное ограничение: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
Baseline, 6-8 weeks postsurgery and 1 year postsurgery
|
|
Recidive prolapse
Временное ограничение: 1 year postsurgery
|
1 year postsurgery
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Kari Indrekvam, phd, MD, Helse Bergen HF, Haukeland University 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 (Оценивать)
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
- 2012/1861
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. .