跳至主要内容
临床试验/NCT00706459
NCT00706459终止不适用

Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2005年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
53
试验地点
1

研究概览

简要总结

In this study, we will use advanced and newly available MR imaging techniques at 3 Tesla (including in situ axial loading and quantitative T1rho, T2, and diffusion measurements) to assess the intervertebral discs and adjacent vertebrae in patients with lumbar back pain scheduled for back surgery (n=20), patients with degenerative disease without classic discogenic back pain (n=10), patients who had discectomies for herniated discs (n=5), and age-matched volunteers without back pain (n=10). In all patients standard imaging procedures will also be performed, including radiographs, standard MRI at 1.5 Tesla and discography. All patients will have specimen of the intervertebral disc harvested at surgery and pathologic analysis and spectroscopy of these specimen will be performed. Post-surgical findings/outcome combined with discography will serve as a standard of reference for the identification of the painful disc(s). The diagnostic performance of the new techniques in assessing the painful disc will be evaluated. We will collect disc specimens from 50 patients undergoing back surgery but did not have pre-surgical MR imaging. These disc specimens will be analyzed in the same manner as the specimens collected from surgical patients who had pre-surgical MRI. This study will serve as a pilot study for a larger project focusing on advanced imaging of the painful intervertebral disc.

We hypothesis that advanced, dedicated MR examinations at 3T can identify painful degenerated discs in patients with chronic lumbar back pain.

研究设计

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

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • prior back surgery (except as mentioned above)
  • spine fractures
  • Radiographic confirmation of facet joint disease or degeneration
  • Radiographic confirmation of sacroiliac joint pathology
  • Lytic spondylolisthesis of spinal stenosis
  • Degenerative spondylolisthesis of > grade 1
  • Metabolic bone disease
  • Spine infection , osteomyelitis
  • Rheumatoid arthritis or any other systemic or autoimmune disease
  • Active malignancy
  • MRI Contraindications (fragment in eye, aneurysms clips, ear implants, spinal nerve stimulators, pacemaker, claustrophobia, or pregnant women, etc.,)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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