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临床试验/NCT02892656
NCT02892656已完成不适用

Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain

Sano1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2017年8月10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
152
试验地点
1
主要终点
Pain Self-efficacy questionnaire

研究概览

简要总结

The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.

详细描述

Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.

An important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.

The measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.

It is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).

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 The Danish Rheumatism Associations' rehabilitation centre Sano
  • Exclusion criteria:
  • a rated physical status of > 3 according to the American Society of Anesthesiologists Physical Status Classification System
  • axial spondyloarthritis
  • spinal fracture within the last 3 months
  • severe osteoporosis
  • active cancer
  • active psychiatric pathology assessed by general practitioner before referral
  • pregnancy
  • low Danish language skills
  • no e-mail address

排除标准

  • 未提供

结局指标

主要结局

Pain Self-efficacy questionnaire

时间窗: 12 months

The PSEQ consists of 10 items, each item is scored on a seven-point Likert scale with responses ranging from 0 (not at all confident) to 6 (completely confident). A total score is calculated by summing the scores of the 10 items yielding a total sum score ranging from 0-60. Higher scores indicate a stronger self-efficacy belief

次要结局

未报告次要终点

研究者

发起方
Sano
申办方类型
Other
责任方
Sponsor

研究点 (1)

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