Melatonin for patients with chronic low back pain (MELBACK) - a randomized placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The between-group difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic LBP
研究概览
简要总结
The aim of this randomized double-blind placebo-controlled clinical superiority trial is to investigate if daily treatment with melatonin 10mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic LBP.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65
- •LBP for 3 months or longer
- •LBP must be present on most days within the past 3 months
- •LBP must limit life or work activities within the past 3 months
- •Average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days
排除标准
- •LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
- •Radiating pain into the leg that goes further (down) than the knee
- •Inflammatory/autoimmune arthritis
- •Severe physical or psychiatric co-morbidities
- •Contraindications to melatonin
结局指标
主要结局
The between-group difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic LBP
The between-group difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic LBP
次要结局
未报告次要终点
研究者
B.W. Koes
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)