Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Low Back Pain or Sciatica Due to Lumbar Stenosis or Spondylolisthesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain
研究概览
简要总结
A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes
详细描述
This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica diagnosed by lumbar X-ray and/or MRI and clinical symptoms including neurogenic claudication at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes with a 5-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 or low back pain (LBP) intensity of NRS ≥5
- •Patients diagnosed with lumbar stenosis based on dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI; or patients diagnosed with lumbar spondylolisthesis based on Meyerding Grade Ⅱ or higher as assessed on X-ray
- •Clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position), if lumbar stenosis patient
- •Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥4 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)
- •Patients with medical history of spinal surgery within the past 3 months
- •Patients who were treated with invasive interventions such as Korean medicine treatment, injections, physical therapy, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
- •Pregnant patients or patients planning pregnancy
- •Patients with serious psychological disorders
- •Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
- •Patients unable to fill out study participation consent form
- •Patients 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 manual medicine, 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 manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Chuna manual medicine (Procedure)
Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, 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 manual medicine, 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 manual medicine, 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 manual medicine, 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 manual medicine, 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 manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Other intervention(s) (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Herbal medicine (Drug)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Chuna manual medicine (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Bee venom pharmacopuncture (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Pharmacopuncture (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Acupuncture (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Electroacupuncture (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Cupping (Procedure)
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
干预措施: Other intervention(s) (Procedure)
结局指标
主要结局
Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain
时间窗: Change from baseline to 4 months
Change from higher score at baseline out of low back pain or radiating leg pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome)
次要结局
- Numeric rating scale (NRS) of radiating leg pain(Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years)
- Visual analogue scale (VAS) of radiating leg pain(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Maximum walking distance (average of the past 3 days)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Oswestry Disability Index (ODI)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- EQ-VAS(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- SF-36([Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years])
- Numeric rating scale (NRS) of low back pain(Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years)
- Visual analogue scale (VAS) of low back pain(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Pain-free walking distance (average of the past 3 days)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Zurich Claudication Questionnaire(Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- EuroQol 5-dimensions 5-levels (EQ-5D-5L)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Adverse reaction(Baseline, every visit for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years)
- Patient Global Impression of Change (PGIC)(8, 16, 20, 24 weeks, 1, 3, 5 years)
- Physical examination(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
- Use of other intervention(s)(Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation