The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.
详细描述
This involves a prospective interventional study with a one year follow-up. The investigators will compare the outcomes of the current rehabilitation pathway with a newly developed (based on systematic review and delphi study) rehabilitation pathway for patients with a single and double level lumbar arthrodesis. The usual care group (n= 30) will be compared with the intervention group (n= 30).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar single and double level arthrodesis
- •Signed informed consent
- •Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)
排除标准
- •Previous arthrodesis in the lumbar spine
- •Musculoskeletal disorders which interfere with functional outcome, f.e. severe lower limb problems not related to the lumbar surgery
- •Presence of one of the following pathologies:Parkinson Multiple sclerose (MS), Cerebral vascular accident (CVA), Peripheral neuropathies, Circulatory disorders, Gout, Rheumatoid disorders, Neoplasia, Septic arthritis, Pregnancy, Vestibular disorder, Infectious diseases
- •Accident at work or lawsuit
- •Low cognition
- •Not able to speak Dutch
研究组 & 干预措施
Intervention group
Rehabilitation with a biopsychosocial focus
干预措施: Rehabilitation with a biopsychosocial focus (Behavioral)
Control group
usual care
干预措施: Control group (Behavioral)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Postoperative: 1 year
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
时间窗: Postoperative: 1 week
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
时间窗: Postoperative: 6 weeks
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
时间窗: Postoperative: 3 months
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
时间窗: Postoperative: 6 months
questionnaire measuring disability related to low back pain
次要结局
- Return-to-work(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Tampa scale for Kinesiophobia (TSK)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- EuroQol five dimensions questionnaire (EQ-5D)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Numeric Rating scale (NRS)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Depression Anxiety stress scale (DASS)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Pain Catastrophizing scale (PCS)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Sit-to-stand(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)
- Patient Specific Functional Scale (PSFS)(Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year)