Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Change in Roland Morris Disability Questionnaire (RMDQ) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Not available for follow-up
- •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)
研究组 & 干预措施
Ibuprofen + placebo + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Ibuprofen 400 mg (Drug)
Ibuprofen + dexamethasone + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Educational Intervention (Behavioral)
Ibuprofen + placebo + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Educational Intervention (Behavioral)
Ibuprofen + dexamethasone + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Ibuprofen 400 mg (Drug)
Ibuprofen + dexamethasone + educational intervention
Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Dexamethasone Oral (Drug)
结局指标
主要结局
Change in Roland Morris Disability Questionnaire (RMDQ) score
时间窗: 2 days (48 hours)
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (Roland-Morris baseline - Roland-Morris day 2)
次要结局
- Analgesic or LBP medication within the previous 24 hours(2 days and 7 days after ED discharge)
- Absolute Roland Morris Disability Questionnaire (RMDQ) score(2 days and 7 days after ED discharge)
- Return to all usual activities(2 days and 7 days after ED discharge)
- Number of visits to any healthcare provider(2 days and 7 days after ED discharge)
- Frequency of Radicular LBP(2 days and 7 days after ED discharge)
- Worst Radicular LBP(2 days and 7 days after ED discharge)
- Satisfaction with Treatment(2 days and 7 days after ED discharge)