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临床试验/NCT04803136
NCT04803136Unknown不适用

The Role of Bone SPECT/CT in Evaluation of Persistent or Recurrent Back Pain Following Spine Surgery

Assiut University0 个研究点目标入组 4 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
4
主要终点
use of SPECT/CT to measure the level of pain either persistent or recurrent after spine stabilization and fusion surgeries at any level of the spine and give a score and make a pain scale before and after therapeutic injection

研究概览

简要总结

  • To evaluate the role of SPECT/CT in assessment of the osteoblastic activity in patients with persistent or recurrent back pain after spine surgery with inconclusive CT/MRI findings.
  • To assess the value of bone SPECT/CT in the management of back pain.

详细描述

Low back pain is a common disorder, with international studies having found prevalence rates between 12% and 35% and life time prevalence rates ranging from 49% to 80%.

It is caused mainly by degenerative spinal disorders, such as spondylolisthesis, degenerative scoliosis, degenerative disc disease and recurrent disc herniations.

The management of low back pain varies from conservative to more invasive methods, such as spinal stabilization surgery that involves the placement of metallic screws, rods, plates or cages. Such surgery is increasingly performed to improve spinal stability in a variety of spine pathologies, including disc degeneration, spinal stenosis and spondylolisthesis.

On the other hand, spinal fusion surgery is performed in patients with severe chronic back pain when segmental instability is believed to cause the symptoms. The rationale for this is that pain relief will be achieved once the fusion restricts motion in the painful segments. For this purpose, a wide array of techniques has been proposed, including dorsal or dorsoventral spondylodesis, either in a one-step or two-step procedure.

It is estimated that more than 300,000 lumbar spinal fusion procedures are performed annually in the United States, and a continuously rising trend has also been observed in other parts of the world.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with persistent/recurrent back pain after spine surgery and inconclusive conventional imaging.
  • •All patients will be clinically assessed by orthopedic surgeons or neurosurgeons specialized and experienced in spine surgery.

排除标准

  • •Patients less than 18 years old.
  • •Patients in whom stabilization surgery is secondary to a destructive bone malignancy (including multiple myeloma).
  • •Patients with known metabolic bone disease (such as Rheumatoid Arthritis, AS & SLE)

研究组 & 干预措施

Bone SPECT/CT

Other

Gamma Camera with computed tomography

干预措施: spine surgeries (Procedure)

Spine surgeries

Other

spine stabilization and fusion surgeries

干预措施: spine surgeries (Procedure)

结局指标

主要结局

use of SPECT/CT to measure the level of pain either persistent or recurrent after spine stabilization and fusion surgeries at any level of the spine and give a score and make a pain scale before and after therapeutic injection

时间窗: up to 2 years

Patients complaining from persistent or recurrent pain after spine stabilization and fusion surgeries at any level of the spine up to two years after surgery do CT/MRI and give inconclusive results, those patients referred to do Single Photon Emission Tomography/Computed Tomography at nuclear medicine unit using radioactive material Technicium99m- Methylene Diphosphonate to measure any increase in osteoblastic activity in the region of the stabilized segment for example at adjacent facet joint, sacrum or endplates and compare it with iliac crest activity then give therapeutic injection at determined increased activity and make pain score before and after therapeutic injection then follow up after 15 days

次要结局

未报告次要终点

研究者

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

Raghda Hassan Mohamed Farweiz

Principal investigator

Assiut University

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