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临床试验/NCT04109781
NCT04109781已完成不适用

Short Clinical Outcome of Microscope Assisted Discectomy: Results of 90 Cases in Iraq

Hawler Medical University0 个研究点目标入组 90 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Oswestry disability index

研究概览

简要总结

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). They are operated by Microscopic assisted discectomy and were followed by ODI and VAS for back pain and leg pain for 4 months after surgery

详细描述

A total of (90) patients involved in this study a randomized sampling use. The adult patient between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy). The diagnosis carried out using history, physical examination, MRI done for the patient to confirm the diagnosis and the level of disc herniation and know the direction and extend of disc herniation.Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.All the patients discharged on the same day of operation or a day after, mobilized soon as they were ready. Patient were reviewed in intervals of (2) weeks (2) months and (4) months after surgery using VAS for low back pain and leg pain and Oswestry disability index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • lower back pain; and or radiculopathy and neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy (life style modification, NSAIDs, and physiotherapy).

排除标准

  • Population excluded from study were the age group above or less the ones whom involved in the study, any other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with cauda equina syndrome, patients with previous back surgery, and with no local infection.

研究组 & 干预措施

Patients with Lumbar disc herniation

Other

Patients with lumbar disc herniation with no response to conservative treatment and were treated with Microdiscectomy

干预措施: Microscope assisted discectomy (Procedure)

结局指标

主要结局

Oswestry disability index

时间窗: Oswestry disability index was assessed preoperatively and postoperatively at 2 weeks , 2 months and 4 months and showed there is improvement in this index after surgery which indicates improvement with microdiscecetomy

Oswestry disability index is low back pain questionnaire as followingFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)

Visual analogue score for back and leg pain

时间窗: Visual analogue score was assessed in all patients preoperatively and then assessed postoperatively at 2 weeks , 2 months and 4 months which showed that there is changes after operation which indicates improvement by Microdiscectomy

Visual analogue score for back pan and leg pain is measurement of patient feeling of pain which can be from 0 (no pain) to 10 ( severe pain )

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Hawler Medical University

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