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临床试验/NCT06057428
NCT06057428招募中不适用

Activity Levels Amongst Elderly Patients With Symptomatic Lumbar Spinal Stenosis Before and After Decompressive Surgery

Region Zealand4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
4
主要终点
Activity level

研究概览

简要总结

Lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, with symptoms including low back pain which worsens with ambulation, poor balance, decreased activity due to pain, and a marked decrease in quality of life (QoL). Prevalence rises with age, and current treatment options range from varied conservative management strategies, to surgical intervention with decompression of neural structures.

While the effects of surgical decompression on back pain and QoL has been widely researched, the effects of surgery on activity levels is less well understood. Though patients generally have subjective improvements in this parameter after surgery, objective measurements in this patient group have been lacking.

This study aims to investigate the effects of decompressive surgery on activity levels in elderly patients with LSS. Measurements of activity will be taken before and after decompressive surgery, as well as with regular intervals during a two-year follow-up period.

A better understanding of the effect that LSS has on activity may lead to more patients being able to receive surgical treatment, which is hypothesized to lead to an increase in QoL and less perceived disability amongst this patient group.

详细描述

Disease background:

While lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, there is no universally accepted definition of LSS, and no accepted radiologic diagnostic criteria. LSS most often refers to a narrowing in the central canal of the vertebrae, the lateral recess, or the neural foramen. Changes to these can occur due to acquired degenerative spondylosis or spondylolisthesis, or more rarely due to conditions such as ankylosing spondylitis and space-occupying lesions, or congenital abnormalities. LSS can be classified according to anatomical location, etiology or severity of narrowing, though no validated classification has been published.

The lack of concrete definition has caused difficulties in estimating the prevalence of LSS. Studies using community-based sampling has shown a prevalence of acquired LSS, defined as a narrowing of the central canal to ≤ 10mm in the anterior-posterior (AP) direction, of 7.3%. The prevalence has been shown to rise with age, from 4.0% affected at < 40 years of age, to 14.3% amongst patients ≥ 60. No significant differences have been observed in overall prevalence according to gender, although there seems to be a slightly higher prevalence amongst elderly females than males.

Although LSS is often asymptomatic, common symptoms of LSS include low back pain, which worsens with prolonged ambulation, lumbar extension and standing, and which is relieved by rest and forward flexion, as well as lumbar radiculopathy. Patients may also complain of poor balance, and physical examination findings may include a wide-based gait and abnormal Romberg results. Symptoms are thought to occur due to compression of microvascular structures in the nerves, allowing for neural ischemia and defects in nerve conduction, and venous pooling resulting in inadequate oxygenation and metabolite accumulation.

Current treatment options for LSS range across both conservative and surgical management strategies. Conservative management has traditionally been regarded as first-line treatment, with a combination approach of physical therapy and pharmacological treatment with NSAIDs and analgesics. Epidural steroid injections have been used for symptom management, though with limited short and long-term benefits. Surgical management is often indicated in patients with ongoing pain despite attempts at conservative management for 3-6 months. Choice of surgical strategy to relieve the pressure on the neural structures depends on the anatomical location of stenosis and number of stenotic segments, as well as the intraoperative assessment of stability.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 65 years
  • Referred to decompressive spinal surgery due to symptomatic lumbar spinal stenosis at ≥ 1 level
  • Central canal LSS grade B or C (Schizas classification) at ≥ 1 level by Magnetic Resonance Imaging
  • Minimum of 3 months of unsuccessful non-operative treatment

排除标准

  • Signs of malignancy or infection in the spinal column
  • Severe comorbidities incl. neurodegenerative conditions which may contribute to balance problems
  • Revision surgery (previous decompression surgery at the same vertebral level)
  • Spinal surgery up to 1 year prior to the date of inclusion
  • Mini Mental State Exam (MMSE) score of ≤ 27 points
  • Degenerative spondylolisthesis more than 3mm on pre-operative imaging diagnostics

结局指标

主要结局

Activity level

时间窗: Before surgery and 3, 6, 12 and 24 months after surgery

Activity level, measured by total activity counts per day (TAC/d)

次要结局

  • Functional disability(Before surgery and 3, 6, 12 and 24 months after surgery)
  • Self-reported activity(Before surgery and 3, 6, 12 and 24 months after surgery)
  • Physical inactivity(Before surgery and 3, 6, 12 and 24 months after surgery)
  • Physical activity(Before surgery and 3, 6, 12 and 24 months after surgery)
  • Quality of life(Before surgery and 3, 6, 12 and 24 months after surgery)

研究者

发起方
Region Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Bremerskov Zielinski

Principal Investigator

Region Zealand

研究点 (4)

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