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临床试验/NCT03388983
NCT03388983Unknown不适用

The Effectiveness of Prehabilitation for Patients Undergoing Lumbar Spinal Stenosis: A Randomized Clinical Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年8月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Chinese/English Version Oswestry Disability Index (ODI)

研究概览

简要总结

Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Patients with LSS,who do not respond to conservative treatments after 3 months or more, will be eligible for spinal decompression surgery in order to improve functional outcomes.

While various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction), little is known regarding the effect of prehabilitation for patients undergoing LSS surgery.

The aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.

详细描述

Lumbar spinal stenosis (LSS) is a common spinal disease that leads to pain and disability. LSS is defined as lower extremity and perineal symptoms (e.g. intermittent neurogenic claudication/numbness) that may occur with or without low back pain and that is attributed to congenital or acquired narrowing of space available for the neural and vascular tissues in the lumbar spine. Clinical symptoms of LSS include pain, numbness, weakness and warmth in bilateral/unilateral buttock or legs that is precipitated by walking or prolonged standing but is alleviated by sitting or forward bending.

Acquired (degenerative) LSS is the most common degenerative conditions that leads to spinal surgery in adults aged 65 years or older.[2] It is known that the occurrence of degenerative LSS increases with age. Given the aging of the global population (including Hong Kong), the prevalence of degenerative LSS is expected to increase. Major causes of degenerative LSS in older adults are the compression and/or ischemia of nerve roots in diminished lateral or central spinal canals secondary to lumbar spondylosis, progressive hypertrophy of ligamentous/osteocartilaginous structures, or degenerative spondylolisthesis. When patients fail to improve after conservative treatments, surgical intervention is recommended for symptomatic LSS. While decompressive laminectomy/laminotomy with or without spinal fusion for LSS has shown significantly less leg symptoms than conservative treatments, up to 40% of patients undergoing LSS surgery were unsatisfied with the postoperative neurogenic claudication and/or radicular leg symptoms. Accordingly, evidence-based management is needed for patients undergoing LSS surgery to optimize patients' recovery.

Various studies have shown that preoperative exercises (prehabilitation) may benefit patients receiving different surgeries (e.g, abdominal surgery, anterior cruciate ligament reconstruction). Although there is a paucity of prehabilitation for patients undergoing LSS surgery. the potential benefits of prehabilitation substantiate the investigation of prehabilitation for patients undergoing LSS surgery.

Given the above, the aim of the current randomized controlled trial is to compare the effectiveness of a 6-week prehabilitation program with usual preoperative care in improving multiple outcomes of patients undergoing LSS surgery at baseline, 6 weeks after baseline evaluation, and at 3 and 6 months postoperatively. It is hypothesized that prehabilitation will yield significantly better pre- and post-operative clinical outcomes as compared to usual preoperative care.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The orthopedic surgeons, outcome assessor and statistician will be blinded to the group allocation of participants.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signs of neurogenic claudication
  • radiological signs of degenerative LSS on magnetic resonance images or computed tomography images
  • radiculopathy with or without low back pain for more than 3 months that is unresponsive to conservative intervention
  • Oswestry Disability Index (ODI) > 30 out of 100
  • patients undergoing open or minimally invasive laminotomy/laminectomy
  • willing to complete pre- and post-operative questionnaires and physical assessments at prescheduled time points

排除标准

  • inability to read, speak and understand English/Chinese
  • inability to give informed consent
  • surgical management for lumbar fractures, tumors, synovial cysts, and scoliosis correction
  • any revision lumbar spine surgery, (5) diagnosis of chronic pain conditions (e.g. fibromyalgia)
  • presence of a neurological or systematic neuromuscular diseases (e.g. multiple sclerosis, stroke, or rheumatoid arthritis)
  • planning for spinal fusion
  • discogenic nerve compression or instability (flexion-extension X-ray film shows > 5mm of sagittal-plane translation)

结局指标

主要结局

Chinese/English Version Oswestry Disability Index (ODI)

时间窗: 6 months

The ODI comprises 10 questions covering areas related to: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, sexual life and traveling.

次要结局

  • Physical activity monitoring(6 months)
  • Pain medication(6 months)
  • 11-point numeric pain rating scale (NPRS) for measuring back/leg pain(6 months)
  • International Physical Activity Questionnaire(6 months)
  • Duration of hospital stay(6 months)
  • The Chinese version of EuroQol-5D-3L for measuring quality of life(6 months)
  • Clinical Global Impression of Change(6 months)
  • Swiss Spinal Stenosis Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Arnold Wong Yu Lok

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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