NCT05003726已完成不适用
Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation : a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Pilot Study
Jaseng Hospital of Korean Medicine4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Oswestry disability index (ODI)
研究概览
简要总结
This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.
详细描述
This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
- •Onset time of radiating pain occurred 3 months before enrollment.
- •Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI), which can explain lower extremity radiation pain and back pain
- •19-69 years old
- •participants who agreed and signed informed consent form
排除标准
- •Spine metastasis of cancer, acute fracture of spine, or spine dislocation
- •Progressive neurologic deficits or severe neurologic deficits
- •Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
- •Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
- •Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
- •Hemorrhagic disease, severe diabetes or taking anticoagulant drug
- •Participants who took NSAIDs within 1 week
- •Pregnant or lactating women
- •Participants who had undergone lumbar surgery within 3 months
- •Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
- •Participants who can not write informed consent
- •Participants who is difficult to participate in the trial according to investigator's decision
结局指标
主要结局
Oswestry disability index (ODI)
时间窗: week 1, 5, 9, 14, 27
ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)
次要结局
- Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Numeric rating scale (NRS) of radiating pain in lower extremities(week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Short form-12 health survey version 2 (SF-12 v2)(week 1, 5, 9, 14, 27)
- Evaluation question(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Drug Consumption(week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Adverse events(week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Numeric rating scale (NRS) of low back pain(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- EuroQol-5 Dimension (EQ-5D-5L)(week 1, 5, 9, 14, 27)
- Credibility and Expectancy(week -1)
- Patient global impression of change (PGIC)(week 9, 14, 27)
研究者
Kyoung Sun Park
Chief, clinical study center
Jaseng Hospital of Korean Medicine
研究点 (4)
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