CTRI/2014/09/004950已完成不适用
A prospective,cross sectional study to find out correlation between supine lying low back pain/leg pain and retrolisthesis in Lumbar disc prolapse patient
Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年8月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Association of supine lying low back pain/leg pain with retrolisthesis
研究概览
简要总结
This is a single centre,prospective,observational study. Patients will be evaluated in single OPD visit over time to obtain target 200 number of patients. A total minimum of two hundred (200) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Patients will be evaluated clinically and using X-ray radiographs, MRI in supine lying position. The total duration of this study is expected to be upto six to twelve ( 6 - 12 ) months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients are included in the study if all of the following criteria are met: 1.Patients having single level disc disease (L4/5 or L5 S1): Degenerative/ Disc prolapse 2.Patients having Supine lying pain (LBP/ leg pain/ discomfort/ numbness).
- •3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures; 4.Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
- •5.Male or Female,having age between 35-70 yrs.
排除标准
- •Patients are excluded from participating in this study if any of the following criteria are met: 1.Has had previous surgery at the index level; 2.Has a fused level adjacent to the index level; 3.Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH); 4.Active systemic or local infection; 5.Known or documented history of communicable disease, including AIDS or HIV; 6.Active hepatitis (receiving medical treatment within two years); 7.Active rheumatoid arthritis, non-controlled diabetes mellitus.
- •8.Immunologically suppressed, history of Paget’s disease, osteomalacia, or any other metabolic bone disease; 9.Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight; 10.Active malignancy.
- •A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years; 11.Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol); 12.Pregnant or planning to become pregnant during study period; 13.Patients who are incarcerated.
- •14.Patients who have limited life expectancy due to significant medical comorbidities.
结局指标
主要结局
Association of supine lying low back pain/leg pain with retrolisthesis
时间窗: 1st Day Assessment
次要结局
未报告次要终点
研究者
研究点 (1)
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