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临床试验/NCT03272893
NCT03272893已完成不适用

The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain

Rikard Wicksell0 个研究点目标入组 90 人开始时间: 2016年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
主要终点
Treatment success

研究概览

简要总结

The goal of this research project is to explore if levels of inflammation predict levels of comorbid mood disorders and treatment success in chronic pain patients. More knowledge in this respect will advance our understanding of chronic pain and comorbid syndromes, and facilitate subgroupings of patients based on the presence and/or level of low-grade inflammation. This research is an important step towards finding an explanation to why treatment effects following behavioral interventions differ across individuals, and generate new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and 2) to investigate if baseline levels of inflammatory biomarkers are associated with psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic pain.

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

入选标准

  • Referred to a specialist clinic within pain management
  • Equal to or older than 18 years
  • Chronic pain (> 6 months)
  • The pain is refractory
  • The pain results in significant functional limitations
  • Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose)

排除标准

  • Spontaneous improvement can be expected (without treatment)
  • Psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b) should be promptly evaluated and possibly treated, or c) may adversely affect the treatment given in the context of the study
  • Significant risk of suicide
  • Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase
  • Language difficulties (Swedish)

结局指标

主要结局

Treatment success

时间窗: At last psychological session (3 months post baseline)

The Pain Disability Index

次要结局

  • Comorbid psychological problems(At first psychological session (baseline))
  • Blood biomarkers as an effect of treatment(At last psychological session (3 months post baseline))

研究者

发起方
Rikard Wicksell
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rikard Wicksell

Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI

Karolinska Institutet

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