Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Functional Impairment as Measured on the Roland Morris Disability Questionnaire
研究概览
简要总结
Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone
详细描述
Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit
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
- •LBP duration <= 2 weeks
- •No trauma to low back within previous month
- •No radicular symptoms
- •No history of low back pain or history of only infrequent episodes
排除标准
- •Medication allergies or contra-indications
- •Not available for follow-up
- •Chronic pain syndrome
研究组 & 干预措施
Placebo
Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo
干预措施: Naproxen (Drug)
Placebo
Naproxen 500mg tablets taken twice per day + placebo. Placebo dose will be either 1 capsule orally twice per day or 1 or 2 capsules orally, thrice per day Naproxen 500mg po BID x 10 days #20 + Placebo
干预措施: Placebo (Drug)
Orphenadrine
Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine
干预措施: Orphenadrine (Drug)
Orphenadrine
Naproxen 500mg, orally twice per day + orphenadrine 100mg, orally twice per day for 10 days Naproxen 500mg po BID x 10 days #20 + Orphenadrine
干预措施: Naproxen (Drug)
Methocarbamol
Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol
干预措施: Methocarbamol (Drug)
Methocarbamol
Naproxen 500mg tablets, orally twice per day + methocarbamol 750mg, orally as 1 or 2 tabs, thrice per day Naproxen 500mg po BID x 10 days #20 + Methocarbamol
干预措施: Naproxen (Drug)
结局指标
主要结局
Functional Impairment as Measured on the Roland Morris Disability Questionnaire
时间窗: 1 week
Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.
次要结局
- Patient Satisfaction With Treatment(1 week)
- Cases of Moderate or Severe LBP(1 week)
- Medications--Patient Self Report of Medication Use(1 week)
研究者
Benjamin W. Friedman, MD
Associate Professor
Montefiore Medical Center