Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Accumulated duration of self-assessed sick leave due to LBP
研究概览
简要总结
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.
This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.
The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.
The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.
The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
详细描述
Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.
The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
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
- Single (Outcomes Assessor)
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
- •Working age adults 18-65
- •Low back pain (current episode of 2-4 weeks)
- •Self-reported physically demanding work
- •Sick-listed or at risk
- •Speak, read and understand Danish
- •Accept workplace visit by the occupational physicians
- •Be in gainful employment for at last 30 hours/week
排除标准
- •Severe somatic or psychiatric comorbidity
- •Pregnancy
- •Cancer or metastatic disease
- •LBP treatment or referral to outside providers (e.g. back-surgery)
- •Contraindications for having a MRI.
结局指标
主要结局
Accumulated duration of self-assessed sick leave due to LBP
时间窗: 6 months
次要结局
- Changes in pain level(6 months)
- Change in Disability(6 months)
- Changes in Fear Avoidance Beliefs scores(6 months)
- Satisfaction with the intervention(6 months)
研究者
Bjarke Brandt Hansen
MD
Frederiksberg University Hospital
