Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Numeric rating scale (NRS) of low-back pain
研究概览
简要总结
This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.
详细描述
This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •low back pain for more than 6 months
- •Numeric rating scale (NRS) score for low back pain 5 or more
- •19-70 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, or psychotropic medications
- •Hemorrhagic disease, severe diabetes or taking anticoagulant drug
- •Participants who took NSAIDs or pharmacopuncture 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
Numeric rating scale (NRS) of low-back pain
时间窗: week 6
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- Visual analogue scale (VAS) of leg radiating pain(week 1, 2, 3, 4, 5, 6, 13, 25)
- Short Form-12 Health Survey version 2 (SF-12 v2)(week 1, 6, 13, 25)
- Korean version of the Roland-Morris Disability Questionnaire (RMDQ)(week 1, 6, 13, 25)
- Numeric rating scale (NRS) of low-back pain(week 1, 2, 3, 4, 5, 6, 13, 25)
- Oswestry Disability Index (ODI)(week 1, 6, 13, 25)
- Patient Global Impression of Change (PGIC)(week 6, 13, 25)
- Numeric rating scale (NRS) of radiating pain in lower extremities(week 1, 2, 3, 4, 5, 6, 13, 25)
- EuroQol-5 Dimension (EQ-5D-5L)(week 1, 6, 13, 25)
- Visual analogue scale (VAS) of low-back pain(week 1, 2, 3, 4, 5, 6, 13, 25)
研究者
In-Hyuk Ha, KMD
Director of Jaseng Spine and Joint Research Institute
Jaseng Medical Foundation