Long Term Follow up of Failed Back Surgery Syndrome(FBSS) Patients With Korean Integrative Medicine Treatment: 10-year Follow-up Prospective Study With Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 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 satisfaction of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observation patients treated with integrative Korean medicine.
This study is a prospective observational study. The subjects for study are patients diagnosed with Failed Back Surgery Syndrome(FBSS) and who have been admitted to Gangnam Jaseng Hospital of Korean medicine and Bucheon Jaseng Hospital of Korean medicine for 2011.11-2014.09.
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
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Failed Back Surgery Syndrome and was admitted to Jaseng hospital of Korean medicine.
- •Patients have agreed to participate the study.
- •Patients who had participated "Long-term course of failed back surgery syndrome (FBSS) patients receiving integrative Korean medicine treatment: a 1 year prospective observational multicenter study"
- •Patients aged 19-70 years on the date
排除标准
- •Patients who are difficult to complete the research participation agreement
- •Other patients whose participation in the trial is judged by a researcher to be problematic
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: Finish survey by June 2021
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
- Korean-Short Form Healthy Survey 36(Finish survey by June 2021)
- Latest treatment(Finish survey by June 2021)
- Patient satisfaction(Finish survey by June 2021)
- Oswestry disability index (ODI)(Finish survey by June 2021)
- Return to daily life(Finish survey by June 2021)
- Spine surgery(Finish survey by June 2021)
- Improvement of patients(Finish survey by June 2021)
- Patient Global Impression of Change (PGIC)(Finish survey by June 2021)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation