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临床试验/NCT04747860
NCT04747860Unknown不适用

Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery. A Prospective Study

KU Leuven9 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
KU Leuven
入组人数
300
试验地点
9
主要终点
Self-reported (sustainable) work resumption assessed by self-report questionnaires

研究概览

简要总结

This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery.

详细描述

Background | Over the past decade, the number of back surgeries in Belgium has substantially increased. However, even after an anatomically successful surgery, 10% to 40% of the patients continue to report pain complaints, causing personal suffering and an enormous economic burden. The specific factors that can predict individual trajectories in postoperative pain, recovery, and work resumption are currently largely unknown.

Aim | The aim of this study is to identify modifiable predictors of work resumption after back surgery.

Methods | In this multisite, prospective, longitudinal study, 300 individuals undergoing back surgery will be followed one-year post-surgery. Prior to surgery, the participants will perform a behavioral computer task to assess fear of movement-related pain and avoidance behavior, and their generalization. In addition, participants will complete questionnaires to assess preoperative fear of movement-related pain, avoidance behavior, optimism, expectancies towards recovery and work resumption, and the duration and severity of the pain before the surgery. Immediately after surgery, as well as six weeks, three months, six months, and twelve months postoperatively, sustainable work resumption, pain severity, disability, and quality of life will be assessed.

Hypothesis | The primary hypothesis is that generalization of fear of movement-related pain and avoidance behavior will negatively affect sustainable work resumption after back surgery. Second, the investigators hypothesize that generalization of fear of movement-related pain and avoidance behavior, negative expectancies towards recovery and work resumption, longer pain duration, and more severe pain before the surgery will negatively affect work resumption, pain severity, disability, and quality of life after back surgery. In contrast, positive expectancies towards recovery and work resumption and optimism are expected positively influence work resumption, pain severity, disability, and quality of life.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Self-reported (sustainable) work resumption assessed by self-report questionnaires

时间窗: 12 months post-surgery

The investigators make a distinction between being fit for work, work resumption, and sustainable work resumption. Being fit for work will be operationalized by not receiving disability benefits. Work resumption will be operationalized by being at work without receiving disability benefits, and time to relapse. Time to relapse is defined as the time for participants to be in sick leave again after being fit for work. Sustainable work resumption will be operationalized by being at work for at least three consecutive months without receiving disability benefits. In addition, the duration of work resumption will be measured.

次要结局

  • Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ(12 months post-surgery)
  • Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale(12 months post-surgery)
  • Self-reported ratings of how much pain the participants experiences, assessed by one question of the short Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)(6 weeks post-surgery)
  • Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)(12 months post-surgery)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johan Vlaeyen

Principal Investigator, Professor

KU Leuven

研究点 (9)

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