Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
研究概览
简要总结
This is a randomized clinical trial comparing two interventions for acute low back pain:
- Ibuprofen + acetaminophen
- Ibuprofen + placebo
Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
- •Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.
- •Patient is to be discharged home.
- •Age 18-69
- •Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
- •Pain duration <2 weeks (336 hours).
- •Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.
- •Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
- •Functionally impairing back pain: 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
研究组 & 干预措施
Acetaminophen
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Acetaminophen (Drug)
Acetaminophen
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Acetaminophen
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Educational intervention (Behavioral)
Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Ibuprofen 600 mg (Drug)
Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Educational intervention (Behavioral)
Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
时间窗: Baseline and one week after discharge from emergency department
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
次要结局
- Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale(7 days after discharge from emergency department)
- Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.(7 days after discharge from emergency department)