Vocational Rehabilitation and Return to Work in Patients With Chronic Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Return to work
研究概览
简要总结
This study aims to evaluate whether a vocational behaviour change ability programme has any additional effect on return to work compared with return to work coordination only in persons with chronic pain.
详细描述
New vocational rehabilitation models including the workplace are urgently needed for persons with chronic pain.
Return to work coordination means external and internal coordination regarding sick leave by help of a rehabilitation coordinator from health care. The goal is to establish a common return to work plan between employer and employee as dictated by Swedish law. The hypothesis is that return to work coordination is not sufficient. Additional effects on return to work and work ability from a behaviour change ability programme aiming to enhance work ability by targeting context at the workplace, physical and psychological functioning, and behavioral skills at work are expected.
The hypothesis is tested in a randomised controlled trial. Before the start of the trial a series of 3-6 experimental single case studies will be performed to study the implementation of the interventions more thoroughly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The outcomes assessors are blinded to study condition during all measurements. Participants and providers of the return to work coordination intervention are blinded until a rehabilitation plan has been completed. Thereafter allocation to study condition is disclosed and the other components of the behaviour change ability programme are provided to those in the experimental group.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain with a duration for more than 3 months
- •On sick-leave 25%-100% from salaried employment or studies, for at least 30 days
- •Identified employer or director of studies
- •Ability to understand, speak, and write Swedish
排除标准
- •Severe substance use disorder
- •Severe psychiatric illness
- •Recruited participants with employers who does not consent to participate
结局指标
主要结局
Return to work
时间窗: Number of days during a 12-month period from baseline to 12 months post baseline.
Average sick leave according to the Swedish Social Insurance registry, defined as net days.
Work ability
时间窗: 12 months
Self-report. Work Ability Index (WAI). The questionnaire covers 7 dimensions: 1. current work ability compared with lifetime best 2. work ability in relation to the demands of the job 3. number of diagnosed illnesses or limiting conditions 4. estimated impairment owing to diseases/illnesses or limiting conditions 5. amount of sick leave during the last year 6. prognosis of work ability in 2 years' time 7. psychological resources. The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability.
次要结局
- Short-term sick leave < 2 weeks, number of days(6 months, 12 months, 24 months)
- Work Ability(Baseline, 6 months, 24 months)
- Return to work(Baseline, 6 months, 24 months)
- Opioid use(Baseline, 6 months, 12 months, 24 months)
- Pain interference: The Brief Pain Inventory(Baseline, 6 months, 12 months, 24 months)
- Health-related quality of life: EQ-5D(Baseline, 6 months, 12 months, 24 months)
- Substance use disorder(Baseline, 6 months, 12 months, 24 months)
- Pain severity: The Brief Pain Inventory(Baseline, 6 months, 12 months, 24 months)
- Balance(Baseline, 6 months, 12 months)
- Functional lifting capacity(Baseline, 6 months, 12 months)
- Fear of movement and reinjury(Baseline, 6 months, 12 months)
- Experience of injustice(Baseline, 6 months, 12 months)
- Physical activity level(Baseline, 6 months, 12 months)
- Catastrophizing(Baseline, 6 months, 12 months)
- Depressive symptoms(Baseline, 6 months, 12 months, 24 months)
- Generalised Anxiety Disorder(Baseline, 6 months, 12 months, 24 months)
- Grip strength(Baseline, 6 months, 12 months)
- Psychological inflexibility in pain(Baseline, 6 months, 12 months)
- Sleep(Baseline, 6 months, 12 months)
- Global goal achievement(6 months, 12 months, 24 months)
- Explorative identification of change in biomarkers(Changes from baseline to 6 months.)
- Cognitive function(Baseline, 6 months, 12 months)
研究者
Pernilla Asenlof
Professor
Uppsala University