Long Term Follow-up of Vertebral Compression Fracture In-patients Treated With Integrated Complementary and Alternative Medicine: A Retrospective Chart Review and Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 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 Vertebral Compression Fracture in-patients by observing inpatients treated with integrative Korean medicine.
This study is a retrospective observational study. The subjects for study are patients diagnosed with Vertebral Compression Fracture and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2022.06.30.
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
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Acute Compression Fracture' of thoracic or lumbar vertebrae from EMR X-ray or MRI, CT imaging (The temporal criterion for dividing acute and chronic compression fractures was based on 3 months after symptoms began in the case of compression fractures caused by osteoporosis, and acute and chronic were also divided based on 3 months after trauma.)
- •Patient hospitalized for more than a week
- •Pateints above 19 years old and below 80 years old
- •Patients who have agreed to participate the study
排除标准
- •Where the vertebral fracture is not a vertebral body, but a transverse protrusion, a polar protrusion, etc.
- •Other chronic conditions that may interfere with the interpretation of treatment effects or outcomes: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
- •If the cause of pain is due to soft tissue disease, not the spine: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
- •a person with a congenital spinal disorder
- •For patients within 3 months of spinal surgery
- •A person who is unable to communicate normally due to dementia or mild cognitive impairment;
- •Other cases where the researcher is not suitable for participation in the study.
- •Those who do not agree to participate in the study.
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: [Time Frame: Finish survey by November 2023]
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)([Time Frame: Finish survey by November 2023])
- Treatment after discharge survey([Time Frame: Finish survey by November 2023])
- Patient Global Impression of Change (PGIC)([Time Frame: Finish survey by November 2023])
- Satisfaction with integrative Korean medicine survey([Time Frame: Finish survey by November 2023])
- The five level version of EuroQol-5 Dimension (EQ-5D)([Time Frame: Finish survey by November 2023])
- Spine Operation([Time Frame: Finish survey by November 2023])
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation