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临床试验/NCT04443738
NCT04443738已完成不适用

Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.

Jaseng Medical Foundation1 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2020年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
378
试验地点
1
主要终点
Numeric rating scale (NRS)

研究概览

简要总结

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.

详细描述

This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
  • Patients undergone MRI readings of central spinal stenosis
  • Patients have no communication problems
  • Patients have agreed to participate the study.

排除标准

  • Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
  • Patient hospitalized for pain caused by a traffic accident
  • Patients with serious mental illness
  • Patients deemed unable to participate in the clinical research by other researchers

结局指标

主要结局

Numeric rating scale (NRS)

时间窗: Finish survey by August 2020

NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.

次要结局

  • Oswestry disability index (ODI)(Finish survey by August 2020)
  • The five level version of EuroQol-5 Dimension (EQ-5D)(Finish survey by August 2020)
  • Patient Global Impression of Change (PGIC)(Finish survey by August 2020)
  • Spine surgery(Finish survey by August 2020)
  • Current symptoms(Finish survey by August 2020)
  • Treatment after discharge(Finish survey by August 2020)
  • hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine(Finish survey by August 2020)

研究者

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

In-Hyuk Ha, KMD

Director

Jaseng Medical Foundation

研究点 (1)

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