Return to Work After Early Intervention for Lumbar Disc Herniation Versus Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Return to work
研究概览
简要总结
The most common cause of low back pain with radiculopathy among the working population is a Lumbar Disc Herniation (LDH). In general, the natural history of sciatica is favourable with spontaneous remission. For the subgroup with more severe symptoms that do not resolve the vocational prognosis is unfavourable in more than 1/3 of the patients. Factors negatively affecting return to work were unskilled labour and less than 40 weeks of employment.
Other than poorer prognosis for patients undergoing discectomy six months or later after the onset of symptoms, there is no consensus on the timing of discectomy. National guidelines in Denmark recommend referral to a spine surgeon if the patient's symptoms have not resolved within 8-12 weeks. However, recent studies have shown that duration of sick leave is associated with poorer clinical outcomes and lower return to work rates.
The purpose of this study is to establish if early surgical evaluation of patients with symptomatic LDH can improve return to work rates. A secondary purpose is to analyse the socioeconomic benefits or costs of an earlier surgical evaluation.
This is a randomized controlled study of two parallel groups of patients who contact their general practitioner for pain relief due to LDH and have been on a minimum of 2 weeks of paid leave. The patients will be randomised to either fast track surgical evaluation or usual care. After informed consent, the subjects will be followed for a period of 12 months.
There are ethical considerations to address including the potential risk of performing surgery if the patient's symptoms could have resolved spontaneously. On the other hand, delayed discectomy could increase the risks of developing chronic pain and loss of work. Thus, the intervention being studied is early referral to a spine surgeon and not discectomy per se. This allows the subject to make a preference-based decision with the surgeon to have a discectomy or not.
详细描述
Design The study design will be a randomized parallel group prospective study of patients from the region of Southern Denmark and the region Zealand with sciatica due to LDH randomized to either early surgical evaluation or usual care as per recommendations from the Danish National Health Board
Study population Study subjects are identified from the patient population in the region of Southern Denmark and the Region of Zealand clinically diagnosed with LDH by their general practitioner.
Randomisation procedure Eligible patients are randomised into one of two arms, usual care or fast track surgical evaluation with a 1:1 Block sealed envelope randomisation used. A randomized block design, stratified by the two surgical sites, is used to ensure equal distribution of the two treatment arms in regions. The randomisation procedure is concealed and administered by the primary investigator. Randomisation is performed after the patient has signed the informed consent form. The result of the randomisation is documented in the subjects' trial record.
Study Arms:
Subject withdrawal If a subject develops a clinically significant medical or surgical condition that in the opinion of the investigator could impact the patient's ability to successfully complete the trial or otherwise interfere with outcomes, the subject will be withdrawn.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed by their GP with LDH
- •Sick leave due to LDH
- •Duration of sick leave less 6 weeks.
- •Age >= 18
- •Able to understand and read Danish
- •Informed consent
排除标准
- •History of previous spine surgery or spinal fracture
- •History of lumbar radiation therapy
- •Current malignant disease or chemotherapy
- •Current pregnancy or breast-feeding
- •Diagnosis of significant psychiatric disorder
- •Contra-indication for spinal surgery or rehabilitation
- •Patients that are not eligible to have an MRI scan
- •Presence of neurologic deficit requiring urgent decompressive spinal surgery
结局指标
主要结局
Return to work
时间窗: 12 months
Self-reported work status. Return to work status one year after entry.
次要结局
- Socioeconomic costs(12 months)
- Patient reported outcome(12 months)
- Surgical rates(12 months)