A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 5 in Functional Impairment
研究概览
简要总结
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac
Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
详细描述
More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women age 18-
- •Present to ED primary for management of Low Back Pain (LBP)
- •Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
- •Musculoskeletal etiology of low back.
- •Non-radicular pain.
- •Pain duration <2 weeks (336 hours).
- •Non-traumatic LBP
- •Participant is to be discharged home.
排除标准
- •Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
- •Not available for follow-up
- •Chronic pain syndrome
- •Allergic to or intolerant of investigational medications
- •Contra-indications to investigational medications
研究组 & 干预措施
Ketorolac + Educational Intervention
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Ketorolac (Drug)
Ketorolac + Educational Intervention
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Educational Intervention (Behavioral)
Ibuprofen + Educational Intervention
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Ibuprofen (Drug)
Diclofenac + Educational Intervention
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Diclofenac (Drug)
Ibuprofen + Educational Intervention
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Educational Intervention (Behavioral)
Diclofenac + Educational Intervention
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
干预措施: Educational Intervention (Behavioral)
结局指标
主要结局
Change From Baseline to Day 5 in Functional Impairment
时间窗: Baseline to 5 days
The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
次要结局
- Worst LBP 2 Days After ED Visit(2 days after Emergency department visit)
- Frequency of LBP 2 Days After ED Visit(2 days after Emergency department visit)
- How Often Participants Used Assigned Medication(24 hours to 5 days)
研究者
Eddie Irizarry
Assistant Professor of Emergency Medicine
Montefiore Medical Center