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Clinical Trials/NCT05585372
NCT05585372RecruitingNot Applicable

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

Cairo University2 sites in 1 country30 target enrollmentStarted: March 20, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Dimension of cervical intervertebral foreman.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Dimension of cervical intervertebral foreman.

Time Frame: 3 months

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

Secondary Outcomes

  • Neck Disability index (NDI)(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Mohamed Aly

Mahmoud Mohamed Aly

Cairo University

Study Sites (2)

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