Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective 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 safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc 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
- Retrospective
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
- •Patient who has a past history of lumbar surgery and has been hospitalized for persistent or recurrent pain and discomfort
- •Patient hospitalized for more than a week
- •Pateints above 19 years old and below 70 years old
- •Patients who 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 limb pain (tumor metastases to the spine, spinal infections, ankylosing spondylitis(AS), acute fractures, spinal dislocation and so on)
- •Patients who have progressive neurological defects or severe synchronic neurological symptoms
- •The cause of the pain is soft tissue problems(tumor, fibromyalgia, rheumatoid arthritis, gout) and not related to spine
- •Patients who have been diagnosed with certain serious diseases that may cause disturbance to interpretation of conclusion (cardiovascular problems, kidney disease, diabetic neuropathy, dementia, epilepsy, and so on)
- •Patients who took steroids, immunosuppressants, psychiatric medications, or other drugs deemed inappropriate by researchers during hospitalization
- •Patient who has visited this medical institution within the last six months.
- •Patients deemed unable to participate in the clinical research by other researchers
- •Patients who haven't agreed to participate the study
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: Finish survey by November 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
- Satisfaction with integrative Korean medicine survey(Finish survey by November 2020)
- Current symptoms survey(Finish survey by November 2020)
- The five level version of EuroQol-5 Dimension (EQ-5D)(Finish survey by November 2020)
- Oswestry Disability Index(ODI)(Finish survey by November 2020)
- Patient Global Impression of Change (PGIC)(Finish survey by November 2020)
- Spine surgery(Finish survey by November 2020)
- Treatment after discharge survey(Finish survey by November 2020)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation