Effect of Duration of Symptoms on the Clinical and Functional Outcomes of Lumbar Microdiscectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Roland-Morris Questionnaire
研究概览
简要总结
97 patients in 3 randomized groups were treated by Microdiscectomy for lumbar disc herniation; Group A was operated at 6 weeks of symptoms, Group B at 3 months and group C at 6 months. These patients were followed for 3 years for the clinical and functional outcomes.
详细描述
150 patients were enrolled in this study and only 97 patients were finally analyzed for primary outcomes measures of Oswestry disability index and Roland-Morris Questionnaire and secondary outcome measures of Visual analogue scale for back pain and leg pain as well as length of hospital stay and time to return for daily activities. Assessments done at different periods of 2 weeks, 3 months, 6 months, 1year, 2 years and 3 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age more than 18 years
- •Disc herniation of L3-4, L4-5 or L5-S1
- •MRI showed disc protrusion or extrusion with nerve root compression corresponding to clinical features.
排除标准
- •Spondylolysis or spondylolisthesis.
- •Spinal deformity like scoliosis.
- •Previous spinal surgery or infection.
- •Cauda equina syndrome.
- •Lumbar segmental instability on dynamic radiograph: translation more than 3 mm or change in angulation more than 10 degrees
- •Diabetes Mellitus
- •Disc herniation other than levels L3-L4, L4-L5 and L5-S1
- •More than single level disc hernaition.
- •Body mass index 30 or more than 30
- •Contained disc herniation by MRI
研究组 & 干预措施
6 weeks
Microdiscectomy was done at 6 weeks of starting symptoms
干预措施: Lumbar Microdiscectomy at 6 weeks of symptoms (Procedure)
3 months
Microdiscectomy was done at 3 months of starting symptoms
干预措施: Lumbar Microdiscectomy at 3 months of symptoms (Procedure)
6 months
Microdiscectomy was done at 6 months of starting symptoms
干预措施: Lumbar Microdiscectomy at 6 months of symptoms (Procedure)
结局指标
主要结局
Roland-Morris Questionnaire
时间窗: Roland-Morris Questionnaire was measured the functional disability at 2 weeks
Primary outcome measure for functional disability, the higher score is worse function
Oswestry disability index
时间窗: Oswestry disability index was measured the functional disability at 2 weeks
Primary outcome measure for functional disability, the higher score is better function
次要结局
- Visual analogue scale(Visual analogue scale was measured at 2 weeks)
- Length of hospital stay(Measuring the days of postoperative hospital stay immediately after the surgery)
- Return to daily activities(Measuring the time needed t return to daily activities immediately after the surgery)
研究者
Sherwan Ahmed Ali Hamawandi
Assistant professor of orthopedic surgery
Hawler Medical University