Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

Обзор

This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Вмешательства

• Препарат Ibuprofen 400 mg
  Ibuprofen 400 mg PO every 8 hours as needed for 7 days
• Препарат Dexamethasone Oral
  Dexamethasone 16 mg PO during ED visit and next day
• Поведенческое Educational Intervention
  Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Первичные конечные точки

• Change in Roland Morris Disability Questionnaire (RMDQ) score [Срок оценки: 2 days (48 hours)]

Вторичные конечные точки (7)

• Worst Radicular LBP [Срок оценки: 2 days and 7 days after ED discharge]
• Frequency of Radicular LBP [Срок оценки: 2 days and 7 days after ED discharge]
• Analgesic or LBP medication within the previous 24 hours [Срок оценки: 2 days and 7 days after ED discharge]
• Absolute Roland Morris Disability Questionnaire (RMDQ) score [Срок оценки: 2 days and 7 days after ED discharge]
• Return to all usual activities [Срок оценки: 2 days and 7 days after ED discharge]
• Number of visits to any healthcare provider [Срок оценки: 2 days and 7 days after ED discharge]
• Satisfaction with Treatment [Срок оценки: 2 days and 7 days after ED discharge]

Критерии участия

Критерии включения

• Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
• Patient is to be discharged home.
• Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.
• Pain duration <2 week
• Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
• Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
• Functionally impairing radicular LBP: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Критерии исключения

• Not available for follow-up
• Pregnant
• Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
• Allergic to or intolerant of investigational medications
• Chronic steroid use
• Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED — The Bronx
• Montefiore Medical Center - Moses ED — The Bronx

Идентификаторы

NCT: NCT05721027 · 2023-14723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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