Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- NRS change from Baseline NRS at discharge
研究概览
简要总结
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
详细描述
Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
- •Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
- •Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
- •Patients aged 19 to 70
- •Patients who have agreed to participate in the clinical study and given written informed consent
- •Patients admitted to a Korean medicine hospital for treatment
排除标准
- •Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
- •Patients admitted due to pain caused by traffic accidents
- •Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
- •Patients with severe mental illness
- •Patients with difficulty or refusal to give sign written informed consent
- •Patients for whom the researchers judge participation in the clinical study to be difficult
- •Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI
研究组 & 干预措施
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Herbal medicine (Drug)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Chuna manual therapy (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Bee venom pharmacopuncture (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Pharmacopuncture (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Acupuncture (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Electroacupuncture (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Cupping (Procedure)
Integrative Korean medicine treatment group
Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
干预措施: Other intervention(s) (Other)
结局指标
主要结局
NRS change from Baseline NRS at discharge
时间窗: Baseline (admission), discharge (up to 14 weeks after baseline)
Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
ODI change from Baseline ODI at discharge
时间窗: Baseline (admission), discharge (up to 14 weeks after baseline)
Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
PGIC
时间窗: 6 months after baseline
Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
次要结局
- SLR from Baseline SLR at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline))
- EQ-5D change from Baseline EQ-5D at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline)
- Lumbar ROM from Baseline Lumbar ROM at each time point(Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline))
- AE(up to 14 weeks after baseline)
- NRS change from Baseline NRS at each timepoint(Baseline (admission), 2 weeks after baseline, 6 months after baseline)
- ODI change from Baseline ODI at each timepoint(Baseline (admission), 2 weeks after baseline, 6 months after baseline)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation