Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Numeric rating scale (NRS) of low back pain
研究概览
简要总结
A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life
详细描述
This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4)
- •Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI
- •Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)
- •Patients who have received surgery recommendation for lumbar spinal stenosis
- •Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 months
- •Patients who have agreed to study participation
排除标准
- •Patients with vascular claudication
- •Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- •Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
- •Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- •Pregnant patients or patients planning pregnancy
- •Patients with serious psychological disorders
- •Patients unable to fill out study participation consent form
- •Subjects deemed unsuitable for study participation as assessed by the researchers
研究组 & 干预措施
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Herbal medicine (Drug)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Chuna manipulation (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Bee venom pharmacopuncture (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Pharmacopuncture (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Acupuncture (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Electroacupuncture (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Cupping (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Other intervention(s) (Other)
结局指标
主要结局
Change in Numeric rating scale (NRS) of low back pain
时间窗: Change from baseline to 3 months
Change in low back pain intensity
Change in Numeric rating scale (NRS) of radiating leg pain
时间窗: Change from baseline to 3 months
Change in radiating leg pain intensity
次要结局
- Numeric rating scale (NRS) of low back pain(Baseline, 1, 2, 3, 6, 12 months)
- Physical examination(Baseline, 1, 2, 3 months)
- Pain-free walking time(Baseline, 1, 2, 3, 6, 12 months)
- Patient Global Impression of Change (PGIC)(6, 12 months)
- Numeric rating scale (NRS) of radiating leg pain(Baseline, 1, 2, 3, 6, 12 months)
- Oswestry Disability Index (ODI)(Baseline, 1, 2, 3, 6, 12 months)
- EuroQol 5-dimensions 5-levels (EQ-5D-5L)(Baseline, 1, 2, 3, 6, 12 months)
- Current medical service use(Baseline, 1, 2, 3, 6, 12 months)
研究者
Jinho Lee
Medical management director
Jaseng Medical Foundation