BION Treatment of Knee Osteoarthritis
BION Implantable Microstimulator System
Обзор исследования
Подробное описание
Тип исследования
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
-
-
California
-
Los Angeles, California, Соединенные Штаты, 90033
- USC University Hospital
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
- Subject is between 18 and 75 years old.
- Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) in the home setting.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.
Exclusion Criteria:
- Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
- Subject has a history of falling.
- Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
- Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
- Subject has cancer.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
- Subject has bilateral knee osteoarthritis.
- Subject is taking pain medications with dosage not stable for one month.
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 |
|---|---|
|
Экспериментальный: BION "twitch" stimulation
The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation.
|
They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
|
Экспериментальный: BION tetanic-frequency stimulation
The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.
|
They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
|
Без вмешательства: Standardized program
A third group of experimental subjects will have a standardized program of voluntary exercise.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
quadriceps isometric strength
Временное ограничение: pre-exercise, 4w, 8w, 12w
|
pre-exercise, 4w, 8w, 12w
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Gait velocity Gait endurance Pain WOMAC
Временное ограничение: pre-exercise, 8w, 12w
|
pre-exercise, 8w, 12w
|
Соавторы и исследователи
Следователи
- Главный следователь: Lucinda Baker, Ph.D, University of Southern California
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
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 (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
- BT5
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. .