Melatonin for Patients With Chronic Low Back Pain - a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Change in low back pain intensity
研究概览
简要总结
Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain.
The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65
- •understand and write Dutch
- •LBP for 3 months or longer
- •LBP must be present on 'most days' or 'every day' within the past 3 months
- •LBP must limit life or work activities on 'some days', 'most days', or 'every day' 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
研究组 & 干预措施
Melatonin
10mg of melatonin daily for a period of 6 weeks
干预措施: Melatonin 10 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in low back pain intensity
时间窗: from baseline to end of treatment at 6 weeks
Change in low back pain intensity (average pain intensity past 7 days), measured on a 0-10 Numeric Rating Scale (NRS) where 0 means no pain and 10 means worst pain imaginable, from baseline to 6 weeks
次要结局
- Back pain-related disability (RMDQ)(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Global perceived effect score(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Physical and mental health measured using the PROMIS Global Health(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Health related quality of life measured using the EQ-5D-5L(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Insomnia measured using the Insomnia Severity Index(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Self-reported number of days with sick leave(baseline to 3 months and 6 months follow-up)
- Emotional functioning using the Beck Depression Inventory (BDI)(baseline to end of treatment at 6 weeks)
- Pain-related anxiety measured using the Pain Anxiety Symptoms Scale(baseline to end of treatment at 6 weeks)
- Neuropathic pain measured using PainDETECT(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
- Productivity losses measured using iMTA Productivity Cost Questionnaire(baseline to 3 months and 6 months follow-up)
- Direct costs of medical care measured using iMCQ Medical Consumption Questionnaire(baseline to 3 months and 6 months follow-up)
- Adverse events(baseline to end of treatment at 6 weeks and 3 months and 6 months follow-up)
研究者
Bart Koes
Prof. dr.
Erasmus Medical Center