KCT0001218招募中未知
The effectiveness of traditional Korean medicine for severe lumbar spinal stenosis with or without spondylolisthesis: a randomized controlled pilot trial
Mok-Hurry Neck & Back Hospital0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 77(Year)(—)
- 性别
- All
入选标准
- •Patients aged with 19 to 77 who have clinical symptoms and signs consistent with lumbar spinal stenosis including low back pain, radicular leg pain or leg discomfort when standing or walking will be included in the study. The patients should have claudication or radicular leg symptoms for at least one year and no symptomatic relief of pain and function related to lumbar spinal stenosis should be experienced at least three months of enough conservative non-surgical treatments including epidural injection therapy, administration of analgesics and (or) physiotherapies. He or she needs to be diagnosed as lumbar spinal stenosis through CT or MRI findings and has been recommended of decompression and (or additionally) fusion surgery by neurosurgeons or orthopedic doctors within one year. Neurogenic claudication should appear within five minutes when walking on a treadmill with 1.5 mile/hour of speed. Finally, the patient should have not been treated with epidural injection during last 1 month.
排除标准
- •1. Patients who show at least one of the following conditions will be excluded from this study:
- •-Past or present existence of a movement disorder and orthopedic problems that might affect the ability to ambulate
- •-Moderate to severe arthritis of the knee or hip that might severely compromise ambulation
- •-Past or present lower extremity peripheral vascular disease or vascular claudication
- •-Previous lumbar spinal stenosis surgery
- •-Serious concomitant medical illness (i.e. heart disease, renal failure and active hepatitis)
- •-Another specific spinal disorder (e.g. ankylosing spondylitis, infection, metabolic diseases or severe osteoporosis)
- •-Presence of major or progressive neurological deficit including dementia
- •-Severe systemic diseases including coronary artery disease or malignancy
- •-Past or present any psychiatric conditions including depression etc.
- •-Present usage of narcotic analgesics including transdermal patch
- •-Present digestive disorders including gastritis, gastric ulcer, irritable bowel syndrome etc.
- •2. Anyone who is pregnant currently or has a plan to be pregnant
- •3. Anyone who is expected to be inappropriate for the participation of this study due to the issues of noncompliance related to the treatments, visit and answering questionnaires
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