Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: FM and MCE, FM and sham-MCE, MCE and sham-FM, Sham-MCE and sham-FM.
- Кому может быть актуально
- Состояния в реестре: Low Back Pain, Low Back Pain, Recurrent. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
Обзор
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
Подробное описание
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
Вмешательства
- Другое FM and MCE
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. - Другое FM and sham-MCE
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises. - Другое MCE and sham-FM
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized. - Другое Sham-MCE and sham-FM
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
Первичные конечные точки
- Change in Patient Specific Functional Scale (PSFS) [Срок оценки: Baseline, 3, 6 and 12 months]
Вторичные конечные точки (12)
- Change in Oswestry [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in PROMIS [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in Tampa Scale of Kinesiophobia [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in Visual analogue Scale [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in Linton Örebro [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in Start back [Срок оценки: Baseline, 3, 6 and 12 months]
- Change in Movement control tests [Срок оценки: Change from baseline at 3 month]
- Change in Spinal mouse [Срок оценки: Change from baseline at 3 month]
- Change in Balance measured with computer [Срок оценки: Change from baseline at 3 month]
- Change in Mobility of the hips [Срок оценки: Change from baseline at 3 month]
- Change in Two-point discrimination [Срок оценки: Change from baseline at 3 month]
- Change in Lef-right discrimination [Срок оценки: Change from baseline at 3 month]
Критерии участия
Критерии включения
- Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.
Критерии исключения
- Specific low back pain cause and earlier fascial manipulation treatment given.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Финляндия · 1 центр
- University Hospital of Oulu — Oulu
Идентификаторы
NCT: NCT03270631 · FM&KCStudy