Observational Study on the Long-Term Course of Integrative Korean Medicine Treatment for Lumbar Intervertebral Disc Herniation: Prospective Multicenter 10 Year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) of radiating leg pain
研究概览
简要总结
This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients who received integrative Korean medicine treatment for 24 weeks as part of a previous clinical study.
详细描述
This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007, and give written informed consent to long-term follow-up assessment at 10 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007
- •Patients who give voluntary written informed consent to long-term follow-up assessment (quantitative and qualitative questionnaires, and MRI) at 10 years.
排除标准
- •Patients who cannot give voluntary written informed consent to this study or answer study questionnaires (e.g. severe psychological disorders)
- •Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
结局指标
主要结局
Change in Visual Analogue Scale (VAS) of radiating leg pain
时间窗: Difference from baseline at 10 years
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain, and a greater change from baseline (If baseline - follow up is a positive value) indicates a better outcome.
次要结局
- Oswestry Disability Index (ODI)(Baseline, 10 years)
- Medical history(10 years)
- Numeric Rating Scale (NRS) of radiating leg pain(Baseline, and 10 years)
- Patient Global Impression of Change (PGIC)(Baseline, 10 years)
- Visual Analogue Scale (VAS) of radiating leg pain(Baseline, and 10 years)
- Lumbar range of movement (ROM)(Baseline, 10 years)
- Straight leg raise (SLR) test(Baseline, 10 years)
- Adverse events(10 years)
- Visual Analogue Scale (VAS) of low back pain(Baseline, and 10 years)
- Numeric Rating Scale (NRS) of low back pain(Baseline, and 10 years)
- 36-Item Short Form Survey (SF-36)(Baseline, 10 years)
- Qualitative questionnaire on 10 year course(10 years)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation