A Study on the Effect of Employment Follow-up on Return to Work in Sick Listed Patients With Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- The primary outcome measure is return to work, measured in number of days patients have been sick listed in both groups.
研究概览
简要总结
Low back pain is a usual conditions in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines are exercise and cognitive intervention effective on pain and function(www.backpaineurope.org), but it have no documented effect on return to work. In addition, there is no documentation that treatments which focus on a single treatment, is effective with regard to return to work for sick-listed patients.
The challenges for health personnel is not cure of the patients back pain, but to build up rehabilitation programs which focus on disability and work incapacity, in patients which are at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated patients with back pain according to the "The PREVICAP model - (PREVention of work handICAP)", where the main purpose with work-related program is to prevent prolonged disability and to help patients back to work. Loisel demonstrated that the PREVICAP models accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model have also been evaluated in Amsterdam, by Dr. Anema with the same results.
At the Back Clinic, Ullevål University Hospital we have evaluated several exercise programs with good effect on pain and function, but not on the return to work rate. We are planning to do a randomized controlled trial after the PREVICAP model. All included patients in both groups, will have an clinical examination by specialist in Physical Medicine and Rehabilitation and an exercise program. Patients will be randomized to a work-related rehabilitations program or to usual care by the general practitioner.
Hypothesis Main hypothesis: Sick-listed patients with back pain, who will be randomized to the work-related rehabilitation programs, will return to work faster than patients randomized to usual care by the general practitioner.
Second hypothesis: A cost-benefit analysis will favor the exercise program and work place intervention
详细描述
Background Low back pain is a usual conditions in the western countries and in Norway 40% of the population report decreased function because of back pain. The disease has great economic consequences, which in 2004 came to 15 billions to disability pension and 1,46 billions to physical treatments.
Severe incidence of back pain, like tumours, infections, fractures and pareses are rare and represent less than 1 % of all cases. The main part is within the category of "non-specific low back pain", which is defined as back pain without specific pathology as known cause.
Based on scientific documentation the back-specialists consider non-specific low back pain as a benign and self-limited condition, while patients expect to get treatment because they experience the condition as painful and disabling.
There are several treatments available for patients with "non-specific low back pain". According to the European guidelines exercise and cognitive intervention has good effects on pain and function (www.backpaineurope.org), but it is not documented effect on return to work. In addition it is not documented that treatments which focus on a single treatment neither is effective regarding return to work for sick-listed patients.
It is a usual myth that physical hard work cause back pain. However, only few studies have demonstrated correlations between hard work and sick-leave. On the contrary several studies have demonstrated that back pain is a multifactorial problem, which is not only due to workers' characteristics, but is also closely related to environmental factors, such as the workplace, the healthcare system, the compensation system and the interaction between all stakeholders in the disability problem.
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
- •Patients with non-specific low back pain sick listed from 6-8 weeks and who are permanently employed.
排除标准
- •Patients with infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis/ listesis, serious somatic disease and/or psychic disease and patients with a poor proficiency in Norwegian.
结局指标
主要结局
The primary outcome measure is return to work, measured in number of days patients have been sick listed in both groups.
时间窗: The duration of the project is estimated to 3 years. The project will start January1st 2008 and the inclusion of patients and the follow-up will be in 2008 and 2009. In 2010 follow-up, statistical analyses, writing and publishing the articles.
次要结局
- The secondary outcome measures are improvement in pain, function, stiffness and fear-avoidance beliefs(The duration of the project is estimated to 3 years. The project will start January 1st 2008 and the inclusion of patients and the follow-up will be in 2008 and 2009. In 2010 follow-up, statistical analyses, writing and publishing the articles.)