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临床试验/NCT01557231
NCT01557231已完成不适用

Epidemiology of OA Pain

Northwestern University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
pain magnitude

研究概览

简要总结

Chronic pain, by definition, persists over long periods of time, but both sufferers of pain and their caregivers are aware that pain levels can fluctuate greatly over time. Being able to define pain variability and its underlying causes would be an important advance in our understanding of chronic pain, and would in turn lead to better approaches to the treatment of chronic pain. In this study, the investigators propose to evaluate in 60 people with chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding magnitude of pain, physical activity level, and medication status twice daily during this period of time. The investigators then will assess the variability in pain levels over time, the frequency of "flares" of osteoarthritis (OA) pain and their relationship to physical activity, medications, and clinical descriptors of the population, e.g., age, gender, body mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA knee pain as well as assessment of subgroups of patients with the overall group being studied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Men and women, age 40 years and above
  • Knee pain most days of the week for the past month
  • Diagnosis of knee OA
  • Meet ACR criteria for knee OA
  • No significant limitations in physical activity
  • Own and able to use a cellular phone capable of text messaging
  • Able to return for all clinic visits
  • Able to read and understand the informed consent document

排除标准

  • Use of a walker to ambulate or inability to ambulate (use of cane is allowed)
  • Other forms of arthritis
  • Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
  • Scheduled for and likely to need joint replacement surgery in the next 3 months
  • Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
  • Living in a long-term care facility

结局指标

主要结局

pain magnitude

时间窗: 6 months

magnitude of pain will be evaluated 3x/day

次要结局

  • self-reported activity level(6 months)

研究者

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

Thomas J. Schnitzer

Professor

Northwestern University

研究点 (1)

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