NCT04576520已完成不适用
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Visual analogue scale (VAS) of low back pain
研究概览
简要总结
This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.
详细描述
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.
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
- 是
入选标准
- •low back pain for more than 6 months
- •Visual Analogue Scale (VAS) of low back pain is more than 5
- •19-70 years old
- •participants who agreed and wrote informed consents
排除标准
- •Migration of cancer reaching to spine, fracture of spine
- •Progressive neurologic deficits or severe neurologic deficits
- •Cancer, fibromyalgia, RA, or goat
- •Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
- •Participants taking steroid, immunosuppressant, or psychotropic medication
- •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 cervical 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
Visual analogue scale (VAS) of low back pain
时间窗: Change from baseline VAS at week 6
Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
次要结局
- Visual analogue scale (VAS) of leg radiating pain(Week 1, 2, 3, 4, 5, 6, 10, 16)
- Numeric rating scale (NRS) of low back pain and leg radiating pain(Week 1, 2, 3, 4, 5, 6, 10, 16)
- Oswestry Disability Index (ODI)(Week 1, 6, 10, 16)
- Patient Global Impression of Change (PGIC)(Week 6, 10, 16)
- Korean version of the Roland-Morris Disability Questionnaire (RMDQ)(Week 1, 6, 10, 16)
- Short Form-12 Health Survey version 2 (SF-12 v2)(Week 1, 6, 10, 16)
- EuroQol-5 Dimension (EQ-5D-5L)(Week 1, 6, 10, 16)
研究者
In-Hyuk Ha, KMD
Director
Jaseng Medical Foundation
研究点 (6)
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