Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament 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
- 78
- 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 Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients treated with integrative Korean medicine.
This study is a prospective observational study. The subjects for study are patients diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31.
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), Vernon-Mior Neck Disability Index (NDI), 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with OPLL by C spine X-ray or MRI or CT
- •Paithents who was admitted to Jaseng hospital of Korean medicien.
- •Patients have agreed to participate the study.
排除标准
- •Patient hospitalized under 3 days
- •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 have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis, gout, and so on)
- •Patients had cervical spinal surgery within 3 months
- •Patients diagnosed with C spine fracture by C spine X-ray or MRI or CT
- •Patients deemed unable to participate in the clinical research by other researchers
- •Patients 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 September 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
- Patient Global Impression of Change (PGIC)(Finish survey by September 2020)
- Current symptoms survey(Finish survey by September 2020)
- Vernon-Mior Neck Disability Index (NDI)(Finish survey by September 2020)
- Spine surgery(Finish survey by September 2020)
- Treatment after discharge survey(Finish survey by September 2020)
- The five level version of EuroQol-5 Dimension (EQ-5D)(Finish survey by September 2020)
- Satisfaction with integrative Korean medicine survey(Finish survey by September 2020)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation