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临床试验/NCT03753711
NCT03753711已完成不适用

Paraspinal Muscle Remodeling in Patients With Unilateral Lumbar Disc Herniation

Hasselt University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
muscle biopsy sample (musculus multifidus)

研究概览

简要总结

Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the posterolateral region. Compression or irritation of the lumbar nerve roots and dural sac can induce unilateral sensory and motor symptoms. Therefore, it is the principal cause of lumbar spinal surgery.

Different imaging studies have investigated asymmetry of the paraspinal muscles in patient with unilateral low back pain due to lumbar discus herniation. Both animal and human studies indicate a reduction in total muscle cross-sectional area, increased fat infiltration and fibrosis within the lumbar multifidus at the affected side.

Increased fat infiltration is clinically important because there is a correlation between the amount of intramuscular fat and lumbar muscle dysfunction. Not only fat infiltration correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is associated with and predictive for low back pain. This indicates that there is an association between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low back pain.

The aim of this research is to quantify the decrease in muscle and muscle fibre size, the amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle at the herniated side in relation to the unaffected side. The second aim is to investigate the possible role of different cell types in the process of muscle remodeling. The last aim of this study is to correlate these muscular changes with long-term functional outcomes such as pain, fear and disability. This information can possibly contribute to the etiology of paraspinal muscle changes, and provide a handgrip to future research.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral lumbar disc hernia (diagnosed using MRI)
  • Age between 18-55
  • Understanding the Dutch language

排除标准

  • Spinal surgery within the last year
  • Degenerative or other spinal pathology (except disc hernia)
  • Contraindications to undergo a MRI
  • Other known pathologies that might affect muscle biology/ morphology

结局指标

主要结局

muscle biopsy sample (musculus multifidus)

时间窗: day 1

Histochemical analyses: Masson's trichrome and haematoxylin and eosin staining will be used to visualize connective and adipose tissues within a muscle cross-section.

MRI

时间窗: day 1

Medical imaging: Pre-operative MRI images will be requested from the department of radiology to measure total muscle cross-sectional area and intramuscular fat infiltration.

次要结局

  • Numeric Pain Rating Score (NPRS)(month 6)
  • Modified Oswestry Disability Index (ODI)(month 6)
  • Tampa Scale for Kinesiophobia (TSK)(month 6)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Vandenabeele

Principal Investigator

Hasselt University

研究点 (2)

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