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临床试验/NCT06359470
NCT06359470已完成不适用

3D CT Scan of the Modified Reversed Contralateral Axial Rotation Position in Patients With Lumbar Disc Prolapse. A New Manual Nerve Decompression Position.

Noha Khaled Shoukry2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Straight leg raising test

研究概览

简要总结

This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine

详细描述

Background: Management of lumbar discogenic pain is complex and there is ongoing debate over both surgical and conventional conservative treatments. Purpose: This study aimed to investigate the real-time effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine. Methods: This study was conducted on ninety male patients (30 in each group), ages ranged from 20 - 40 years old, and were diagnosed with unilateral lumbar disc prolapse (group1: L3-L4), (group 2: L4- L5) and (group 3: L5-S1) for at least three months in a radiology center specialized in the spine (Egyscan center). Each group was imaged three times (from the supine position, then from the oblique position after 10 minutes, and finally from the oblique position again after 48 hours). The oblique image was taken during a specific trunk position the modified reversed contralateral rotation (side-lying on a hard pillow with side bending to the non-affected side and rotation to non affected side).The CSA of LIVF and SLR test were assessed at the three times of testing Results: The mixed design MANOVA revealed that the mean values of the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 48 hours compared to the same position after 10 minutes and the supine position in the three tested groups (P=0.001). Moreover, the LIVF CSA and the SLR significantly increased in the reversed contralateral rotation position after 10 minutes compared to the supine position in the three tested groups (P=0.001). Conclusion: Modified reversed contralateral rotation of the trunk has a real-time decompressing effect on patients with lumbar disc prolapse as well as a significantly increasing effect on the CSA of L3-L4, L4-L5 and L5-S1 IVF in the three tested groups. Changing the spine position from supine to the modified reversed contralateral rotation position had a great clinical value on patients with lumbar discogenic pain with radiculopathy.

研究设计

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

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients had a second-grade disc bulge (2-3mm) which was detected from the T2 axial view of MRI. All patients had radiculopathy due to lumbar disc prolapse. The diagnosis was confirmed by physical, neurological examination (motor assessment, sensory assessment, reflexes), and radiological assessment (CT or MRI)

排除标准

  • bilateral and multilevel disc prolapse, sequestrated , migrated and disc herniation defined by MRI , acute onset of pain (pain less than three months), presence of active infection in the lumbar spine, any spinal deformities e.g., moderate, or severe scoliosis deformity (Cobb angle ≥ 25°), postoperative cases, Cauda equine lesion, the presence of any comorbidities, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness

结局指标

主要结局

Straight leg raising test

时间窗: 48 hours

With the patient in the supine position and the hips were neutral, neither abducted nor adducted nor rotated, the investigator lifted the leg slowly while the knee was kept in extended position. Each leg is raised separately until pain occurs. When the patient reported feeling radiating pain the angle between the bed and the leg was recorded by a goniometer

次要结局

  • Foraminal cross sectional area(48 hours)

研究者

发起方
Noha Khaled Shoukry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Noha Khaled Shoukry

lecturer

Cairo University

研究点 (2)

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