Rehabilitation After Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
研究概览
简要总结
Rehabilitation after lumbar disc surgery (prolapse) focuses on various elements such as endurance, strength, stretching and information. Evidence concludes that it is not harmful to return to activity after lumbar disc surgery, and restrictions to activities after these operations are today more or less nonexistent. Some studies have shown that high intensity programs might be more effective, but they are probably more expensive. In recent years cognitive interventions have received more attention in rehabilitation programs after lumbar disc surgery. The cognitive approach is focused on providing patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases. A goal of the rehabilitation is to get the patient to resume normal activities. Reviews ask for how much treatment are needed in a rehabilitation program after lumbar disc surgery.
The study will be a randomized clinical trial. The study will compare two different post-operative rehabilitation programs (general information or general information + exercise therapy). Both groups will begin treatment 1 day after surgery. Subjects in exercise therapy group are supposed to continue with exercises 3 months.
In this study the following hypothesis will be studied:
- Brief intervention, an educational model, alone after lumbar disc surgery do have the same effect on pain in legs and low back as brief intervention, an educational model, combined with exercise therapy.
- Exercises which are instructed after lumbar disc surgery in a rehabilitation program, are being done by the patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with lumbar disc prolapse with radicular pain
- •Age between 18 and 60
排除标准
- •Previous lumbar disc surgery (prolapse)
- •Spondyloarthritis
- •Arthritis
- •Systematic disease
- •Heart disease
- •Does not understand Norwegian language, spoken or in writing
研究组 & 干预措施
Brief intervention only
Brief intervention, an educational model, consists of information
干预措施: Brief intervention, an educational model (Other)
Exercise group
Brief educational intervention combined with exercise therapy
干预措施: Brief intervention, an educational model (Other)
Exercise group
Brief educational intervention combined with exercise therapy
干预措施: Exercise therapy (Other)
结局指标
主要结局
Change from baseline in pain in the low back and the legs at 6-8 weeks and 1 year postsurgery
时间窗: Baseline, 6-8 weeks postsurgery and 1 year postsurgery
次要结局
- Change from baseline in health condition at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Change from baseline in health condition rating at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Change from baseline in Fear-Avoidance Beliefs Questionnaire (physical activity) at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Recidive prolapse(1 year postsurgery)
- Change from baseline in Tampa scale of Kinesiophobia (TSK-13) at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Disability and beliefs about the condition(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Change from baseline in Oswestry Disability Index at 6-8 weeks and 1 year postsurgery(Baseline, 6-8 weeks postsurgery and 1 year postsurgery)
- Change from baseline in anticipation to return to work at 6-8 weeks postsurgery(Baseline and 6-8 weeks postsurgery postsurgery)