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临床试验/NCT03548454
NCT03548454已完成4 期

Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Stanford University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
86
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Duloxetine

Experimental

Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.

干预措施: Duloxetine (Drug)

Desipramine

Experimental

Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.

干预措施: Desipramine (Drug)

结局指标

主要结局

Pain Intensity

时间窗: baseline and 6 months

Percent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).

次要结局

  • Physical Function(Baseline and 6 months)
  • Pain Interference(Baseline and 6 months)
  • Depression(Baseline and 6 months)
  • Anxiety(Baseline and 6 months)
  • Adherence(Monthly for 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vafi Salmasi

Clinical Instructor

Stanford University

研究点 (1)

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