Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Numeric rating scale (NRS) of radiating pain in lower extremities
研究概览
简要总结
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
详细描述
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 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 intervention and dosage of pharmacological and non-pharmacological treatment.
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
- •Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
- •Onset time of radiating pain occurred within 12 weeks.
- •Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
- •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, orpsychotropic medications or any other medication that can interrupt the study result
- •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 radiating pain in lower extremities
时间窗: week 9
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
次要结局
- Numeric rating scale (NRS) of radiating pain in lower extremities(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Visual analogue scale (VAS) of low-back pain(week 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)
- Numeric rating scale (NRS) of low-back pain(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Visual analogue scale (VAS) of leg radiating pain(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
- Oswestry Disability Index (ODI)(week 1, 5, 9, 14, 27)
- Patient Global Impression of Change (PGIC)(week 9, 14, 27)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(week 1, 9, 14, 27)
- EuroQol-5 Dimension (EQ-5D-5L)(week 1, 5, 9, 14, 27)
研究者
Kyoung Sun Park
Chief, Clinical study center
Jaseng Hospital of Korean Medicine