Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Change in Visual analog scale (VAS)
研究概览
简要总结
The objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.
详细描述
Patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-Amitriptyline 5 mg for 2 months 2- placebo for 2 months. Co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to Visual Analog Scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (Bergen insomnia scale, neck pain disability score, neck pain diary & anxiety and depression score). Patients are followed at 2 months and outcome measures are assessed.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neck pain (since more than 3 months, and more than 15 days/month)
- •Normal neurologic exam
- •X-ray = normal or loss of lordosis
排除标准
- •Neurologic signs or symptoms
- •Past history of neck surgery
- •MRI = abnormal findings except for loss of lordosis
- •Past cervical trauma
- •severe depression
- •drug abuse
- •pregnancy
- •Follow-up not possible
- •cardiac rhythms problems
- •Urinary tract obstruction or prostatism
研究组 & 干预措施
Amitryptiline
Amitryptiline 5 mg before bedtime
干预措施: Amitryptiline (Drug)
Placebo
Placebo pill
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Visual analog scale (VAS)
时间窗: 0 and 2 months after treatment
Pain assessment on VAS at 2 months compared to baseline
次要结局
- Change in Bergen insomnia score(0, 2 months)
- side effects(Up to 12 weeks after treatment)
- Percentage of satisfaction(2 months after treatment)
- Change in Hospital Anxiety and Depression Scale (HADS)(0 and 2 months after treatment)
- Change in Neck pain disability score(0, 2 months)
研究者
Dr Joseph Maarrawi
Assistant Professor : Researcher - Pain Specialist - Neurosurgeon
St Joseph University, Beirut, Lebanon