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临床试验/NCT06113263
NCT06113263已完成不适用

The Differences Between Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache - a Registry Study with 2-year Follow-up

Linkoeping University0 个研究点目标入组 2,889 人开始时间: 2014年1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
2,889
主要终点
Neck Disability Index

研究概览

简要总结

This is a prospective observational register-based cohort study with 2 years follow-up with data from the national Swedish Spine Register (Swespine). The aim is to study the differences between anterior and posterior decompression surgery on neck-related disability, headache, and neck- and arm pain in individuals with cervical radiculopathy and headache. Secondary, to study predictive factors for an improvement in neck-related disability, headache and neck- and arm pain after decompression srurgery. All individuals underwent either anterior or posterior decompression surgery and were operated between 2014-2021. Patient-reported data was collected preoperatively (baseline), and at 1- and 2-year follow-ups and surgeon-reported data regarding the operation were collected directly after the operation. Primary outcome is self-reported neck-related disability measured with Neck Disability Index and secondary outcomes are headache, measured with an item about headache of Neck Disability Index, and neck- and arm pain, measured with a 0 to 10-point numeric rating scale.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Underwent anterior cervical decompression surgery or posterior cervical foraminotomy with or without laminectomy for cervical radiculopathy 2014 - 2021
  • Age ≥ 18 years
  • Preoperatively rated 1 (I have slight headaches, which come infrequently) - 5 (I have headaches almost all the time) on an item about headache of Neck Disability Index (27)

排除标准

  • Myelopathy
  • Previous neck surgery

结局指标

主要结局

Neck Disability Index

时间窗: Preoperatively to 24 months follow-up

To measure neck-specific disability; 0-100 % (0 % = no disability)

次要结局

  • Headache measured with an item of Neck Disability Index(Preoperatively to 24 months follow-up)
  • Numeric rating scale(Preoperatively to 24 months follow-up)
  • Bakground variables(Preoperatively)
  • Duration of neck pain(Preoperatively)
  • Duration of arm pain(Preoperatively)
  • Work status(Preoperatively)
  • Consumption of pain-relieving drugs(Preoperatively)
  • Walking ability(Preoperatively)
  • Specific questions about operation data(Immediately after the operation)
  • Self-reported other diseases that greatly limit the quality of life(Preoperatively)
  • EQ-5D-3L index(Preoperatively)

研究者

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

Jard Svensson

MSc

Linkoeping University

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