Efficacy of Epidural Etanercept in the Treatment of Sciatica
Ключевые слова
абстрактный
Описание
As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.
Даты
| Последняя проверка: | 12/31/2008 |
| Первый отправленный: | 08/13/2006 |
| Предполагаемая регистрация отправлена: | 08/13/2006 |
| Первое сообщение: | 08/14/2006 |
| Последнее обновление отправлено: | 01/20/2009 |
| Последнее обновление опубликовано: | 01/21/2009 |
| Фактическая дата начала исследования: | 04/30/2006 |
| Предполагаемая дата завершения начальной школы: | 11/30/2007 |
| Предполагаемая дата завершения исследования: | 11/30/2007 |
Состояние или болезнь
Вмешательство / лечение
Drug: Epidural injection of etanercept
Drug: 1
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Placebo Comparator: 1 Two injections of epidural saline 2 weeks apart | Drug: 1 Two injections of epidural saline 2 weeks apart |
| Experimental: Epidural injection of etanercept Two injections of epidural etanercept 2 weeks apart | Drug: Epidural injection of etanercept 2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: 1. Chronic low back pain of radicular origin of > 2 months but < 1 year duration. 2. Failure of conservative therapy to include physical and pharmacotherapy. 3. MRI evidence of a herniated disc corresponding to the patient's radicular symptoms. 4. Normal white blood cell count (drawn in 1 blood vial). Exclusion Criteria: 1. Uncontrolled coagulopathy. 2. Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists. 3. Allergy to contrast dye. 4. Unstable medical condition (e.g., unstable angina or congestive heart failure). 5. Rheumatoid arthritis, Crohn's disease or spondylarthropathy. 6. Unstable neurological condition (e.g., multiple sclerosis) 7. Systemic infection 8. Age < 18 or > 70 years. |
Результат
Основные показатели результатов
1. Visual analogue scale pain score, Oswestry disability index, medication intake [7 months]
Меры вторичного результата
1. Global perceived effect, white blood cell count [7 months]
