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临床试验/NCT03974191
NCT03974191已完成不适用

13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

Vastra Gotaland Region3 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2019年6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
87
试验地点
3
主要终点
Activity limitation

研究概览

简要总结

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain.

Purpose: To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability.

Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006.

The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

详细描述

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain.

How LBP develops into recurrent and or more persistent pain with disability is not fully understood. Prognostic factors for pain development, work ability and self-rated activity limitation in 1 and 2-year follow-ups of persons with CLBP who sought primary care are described. Performance on physical capacity tests (6-min walking test), limitations on self-rated activity and participation and psycho-social factors play a role in unfavorable pain and function development. However, there are patients with CLBP who have no anatomical, demographic or psychosocial explanation of their symptoms. Some people with CLBP also have widespread pain and show altered pain sensitivity as fibromyalgia.

Purpose:To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability.

Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006.

Participants will be assessed by a registered physiotherapist at one occasion. Demographic data are collected, Questions about social support, sleep quality and sleep quantity, smoking and alcohol consumption. Self-reported questionnaires, pain and function performance tests will be assessed.

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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All participants (n=131) included in the Cross Sectional Study in 2006

排除标准

  • Serious somatic disorders
  • Serious psychiatric disorders

结局指标

主要结局

Activity limitation

时间窗: 2019, change from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for activity limitation (RMDQ) at the 13-year follow-up

Roland and Morris Disability Questionnaire (RMDQ) will be used.

Pain intensity

时间窗: 2019, Change from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for pain intensity (VAS) at the 13-year follow-up.

A Visual Analogue Scale (VAS), ranging 0 to 100 mm will be used for pain intensity during the last week. 0 mm indicates no pain and 100 mm indicates very severe pain. Higher score indicates more severe pain.

Work ability

时间窗: 2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for work ability at the 13-year follow-up.

Sick-leave periods, and sickness and activity compensation is obtained from the Swedish Social Insurance Agency's MiDAS database. Self-reported work status dichotomized into two categories, work ability or not will be used.

次要结局

  • Pain distribution(2019, Comparison from the first assessment (2006) to the present 13-year follow-up (2019), identify predictors (2006) for pain distribution at the 13-year follow-up.)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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