KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline in 'Roland Morris Disability Questionnaire'
研究概览
简要总结
The Purpose of this trial is to define the characteristics of the in/outpatients with low back pain in traditional Korean medicine rehabilitation clinic. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients the investigators are able to enter into the registry, the more the investigators will be able to understand the low back pain and learn better ways of caring for patients.
详细描述
KLOS, prospective, multi-center, patient registry pilot study will collaborate with 7 Korean medicine hospitals and plan to recruit low back pain patients into the registry. 150 eligible patients with new episode of LBP who visit Korean medicine hospital without any other treatment history will enroll to the registry. After enrollment, study collect the individual characteristics of patient's status such as pain intensity, LBP related daily disability, anthropometrics, HRQoL at baseline, 30 and 90 days. We also access to the patient's clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to: 1) explore the general characteristics of new episode of LBP patients and; 2) evaluate the efficacy and safety of various Korean medicine treatments on low back pain based on nationwide registry outcome collecting process.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients with chief complaint of low back pain in Korean medicine rehabilitation center
- •Age greater than or equal to 19
- •Ability to have normal communication
- •Ability to give informed consent
排除标准
- •Patients with low back pain which caused by other diseases(ex. lumbar herniated disc-surgery within past 3 months, vertebral fracture, inflammatory spondylitis, spinal infection, metastatic cancer etc.);
- •Patient with musculoskeletal pain which is more severe than lower back pain;
- •Patients with chronic disease may affect the results of clinical trial;
- •Treated with medication for low back pain within past 4 months;
- •Participated in other low back pain clinical trials within past 1 month;
- •Patients who are Inability to communicate, such as alzheimer's disease or mild cognitive impairment;
- •Pregnant women;
- •Patients who are judged to be inappropriate for the clinical study by the researchers
结局指标
主要结局
Change from Baseline in 'Roland Morris Disability Questionnaire'
时间窗: at Baseline, 30 days after registration
This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
次要结局
未报告次要终点
研究者
Yun-Kyung Song
KMD, PhD
Gachon University Gil Oriental Medical Hospital