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临床试验/NCT03836586
NCT03836586已完成不适用

Contribution of Pain Catastrophizing to Race Group Differences in Pain and Pain-Related Brain Responses in Older Adults With Knee Osteoarthritis (OA)

University of Florida2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Pain Catastrophizing Scale (PCS) at Day 2

研究概览

简要总结

This study proposes to experimentally manipulate pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain among non-Hispanic Blacks (NHBs) and non- Hispanic Whites (NHWs) with knee osteoarthritis (OA). Therefore, participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symptomatic knee OA

排除标准

  • Younger than 45 years of age or older than 85 years of age
  • Prosthetic knee replacement or other clinically significant surgery to the arthritic knee
  • uncontrolled hypertension (>150/95)
  • Heart disease including heart failure
  • Peripheral neuropathy in which pain testing was contraindicated
  • Systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia
  • Neurological diseases such as Parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures
  • Significantly greater pain in body sites other than in the knee
  • Daily opioid use
  • Hospitalization within the preceding year for psychiatric illness
  • Currently pregnant or nursing/breastfeeding

结局指标

主要结局

Pain Catastrophizing Scale (PCS) at Day 2

时间窗: Day 2

13-item scale that assesses catastrophic thinking associated with pain. The study team will administer the PCS using traditional instructions (a measure of trait catastrophizing) and instructions to assess situation-specific catastrophizing ("Thinking back to your experience during the laboratory pain testing"). Thoughts and feelings concerning pain are ranked on a 0-4 scale, with 0 being the patient has this thought/feeling 'not at all' to 4, the patient has this thought feeling 'all the time.' The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. Higher scores indicate the presence of catastrophizing and therefore worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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