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临床试验/NCT05585372
NCT05585372招募中不适用

EFFECT OF RADIOLOGICAL GUIDED MOBILIZATION ON CERVICAL INTERVERTEBRAL FORAMEN IN PATIENTS WITH CANAL STENOSIS

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Dimension of cervical intervertebral foreman.

研究概览

简要总结

Applying specific opening mobilization of cervical intervertebral foramen is still unclear as well as the effect of mobilization on intervertebral foramen dimensions. using CT guidance to determine the wright direction of mobilization through studying the kinematics of intervertebral foramen will enhance better results and less risk of mobilization during manual therapy of cervical canal stenosis.

详细描述

The purpose of the present study is:

  1. To measure dimensions of cervical intervertebral foramen in case of peripheral canal stenosis
  2. To study the effect of uniaxial positions and multi axial positions on the dimensions of intervertebral foramen in case of cervical foraminal stenosis
  3. To detect the proper direction of opening mobilization for cervical intervertebral foramen
  4. To test the effect of applying grade four Maitland mobilization to the affected spinal unit IVF.
  5. To study the effect mobilization on the cervical intervertebral foramen OF C5/6.
  6. To study the effect of specific mobilization on the cervical radiculopathy

subjects and methods:

  1. Thirty male patients represent the sample of this study.
  2. The age of the patients range from 25 to 40 years. The body weight range from 75 to 90kg. The height range from 175 to 185Cm.
  3. Each patient has disc prolapse at C5-C6 and the duration of illness ranged from three months to one year.
  4. Each patient suffers from cervical radiculopathy from disc prolapse at C5-C6 and the duration of illness range from three months to one year.
  5. Each patient will be subjected to physical, neurological examination (motor assessment, sensory assessment) and electrophysiological assessment (H-reflex).
  6. Each patient will be subjected to 3D CT scan from 6 separate positions in two visits to the Alpha Scan Radiology lab, 3 positions in each visit to avoid over dose of exposure to X ray.
  7. The six positions are:
  • Neutral
  • Side bending
  • Axial rotation
  • Flexion with ipsilateral rotation
  • Flexion with contralateral
  • Extension with contralateral rotation
  1. IVF width & Hight will be measured from the 3D CT from each position for Right (Rt) & left (Lt) IVF.
  2. Direction of CT scan volume will 45 degree with sagittal plan and 10 to 15 degrees below the transverse plane.

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, Care Provider, Outcomes Assessor)

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 suffer from paramedian cervical disc prolapse (C5-C6) for at least three months up to one year. The age of the patient range from 25 to 40 years. The body weight range from 75 to 90kg. The height ranged from 175 to 185cm.
  • All the patients has unilateral cervical radiculopathy.
  • Diagnosis will be confirmed by clinical and radiological assessment (CT or MRI).

排除标准

  • Sever central canal stenosis and cervical myelopathy .
  • Sequestrated and migrated disc prolapse.
  • Acute onset of pain (pain less than three months).
  • Presence of active infection in cervical spine.
  • Postoperative cases.
  • Patient suspected to chemotherapy and radiotherapy.
  • Cervical instability.

结局指标

主要结局

Dimension of cervical intervertebral foreman.

时间窗: 3 months

Width and Height of Cervical intervertebral foreman measured by 3 Dimensions Computed Tomography (CT.)

次要结局

  • Neck Disability index (NDI)(6 weeks)

研究者

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

Mahmoud Mohamed Aly

Mahmoud Mohamed Aly

Cairo University

研究点 (2)

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