Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 665
- 试验地点
- 1
- 主要终点
- Change from Baseline Numeric rating scale(NRS) to longterm f/u survey
研究概览
简要总结
The purpose of this study is to reveal the effectiveness of integrative Korean medicine for trauma fracture by observation inpatients treated with integrative Korean medicine.
This study is a prospective observational study. The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.
Medical records of selected patients will be analyzed, and online google surveys(or telephone) will be conducted for each patient. The survey questions are Numeric rating scale (NRS), 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-85 years old
- •Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
- •fracture caused by trauma
- •Patients have agreed to participate the study.
排除标准
- •pathological fracture, stress fracture
- •Open fracture
- •The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
- •Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
- •lack of data of collection
- •Patients deemed unable to participate in the clinical research by other researchers
结局指标
主要结局
Change from Baseline Numeric rating scale(NRS) to longterm f/u survey
时间窗: baseline(admission), week 1, 2, 3, 4, 5, 6, 7, day of Discharge(up to week 8), finish f/u 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'.
次要结局
- Oswestry disability index (ODI)(baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021)
- Neck Disability Index (NDI)(baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021)
- hanbangchilyo manjogdo (Satisfaction with integrative Korean medicine)(at finish f/u survey by June 2021)
- The five level version of EuroQol-5 Dimension (EQ-5D)(baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021)
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021)
- Shoulder Pain and Disability Index (SPADI)(baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021)
- Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH)(at finish f/u survey by June 2021)
- Symptoms of RIB,STERNUM fracture(at finish f/u survey by June 2021)
- the Hip Disability and Osteoarthritis Outcome Score(HOOS)(at finish f/u survey by June 2021)
- the Foot Function Index (FFI)(at finish f/u survey by June 2021)
- Patient Global Impression of Change (PGIC)(at finish f/u survey by June 2021)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation