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EFFECT OF CT GUIDED MOBILIZATION ON CERVICAL FOREMAN'S DIMENSIONS

Primary Purpose

EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CT guided opening mobilization of cervical intervertebral foreman
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. All the patients has unilateral cervical radiculopathy.
  3. Diagnosis will be confirmed by clinical and radiological assessment (CT or MRI).

Exclusion Criteria:

  • 1. Sever central canal stenosis and cervical myelopathy . 2. Sequestrated and migrated disc prolapse. 3. Acute onset of pain (pain less than three months). 4. Presence of active infection in cervical spine. 5. Postoperative cases. 6. Patient suspected to chemotherapy and radiotherapy. 7. Cervical instability.

Sites / Locations

  • ElRazzy Spine physical therapy clinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

CT guided opening mobilization of cervical intervertebral foreman

Arm Description

The control group will receive general stability exercises and neurodynamic mobilization only

Grade four manual therapy mobilization of cervical intervertebral foreman guided by 3 dimensions computed tomography (CT) as following : Determining the poper direction of cervical IVF by 3D CT. the patients lies in supine with his head resting comfortably at the position which cause maximum opening of the intervertebral foramen which has been determined by the 3D CT. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment. Passive mobilization techniques were progressed, utilizing unilateral posteroanterior mobilization of the mid and lower cervical spine and lateral gliding movements, in both directions, progressing in duration and intensity to allow a graded exposure of load. Sustained Natural Apophyseal Glides (SNAGS) were used mainly as self-treatment techniques to maintain the gains that achieved.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neck Disability index (NDI)
Neck pain and function Questionnaires

Full Information

First Posted
October 14, 2022
Last Updated
April 5, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05585372
Brief Title
EFFECT OF CT GUIDED MOBILIZATION ON CERVICAL FOREMAN'S DIMENSIONS
Official Title
EFFECT OF RADIOLOGICAL GUIDED MOBILIZATION ON CERVICAL INTERVERTEBRAL FORAMEN IN PATIENTS WITH CANAL STENOSIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: To measure dimensions of cervical intervertebral foramen in case of peripheral canal stenosis To study the effect of uniaxial positions and multi axial positions on the dimensions of intervertebral foramen in case of cervical foraminal stenosis To detect the proper direction of opening mobilization for cervical intervertebral foramen To test the effect of applying grade four Maitland mobilization to the affected spinal unit IVF. To study the effect mobilization on the cervical intervertebral foramen OF C5/6. To study the effect of specific mobilization on the cervical radiculopathy subjects and methods: Thirty male patients represent the sample of this study. 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. Each patient has disc prolapse at C5-C6 and the duration of illness ranged from three months to one year. Each patient suffers from cervical radiculopathy from disc prolapse at C5-C6 and the duration of illness range from three months to one year. Each patient will be subjected to physical, neurological examination (motor assessment, sensory assessment) and electrophysiological assessment (H-reflex). 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. The six positions are: Neutral Side bending Axial rotation Flexion with ipsilateral rotation Flexion with contralateral Extension with contralateral rotation IVF width & Hight will be measured from the 3D CT from each position for Right (Rt) & left (Lt) IVF. Direction of CT scan volume will 45 degree with sagittal plan and 10 to 15 degrees below the transverse plane. Limitations: An effort will be made to minimize the effect of the possible errors. The limitations of the study are mostly due to: Difference of psychological status of the patients. Cost of Radiological imaging processing. Time consuming. Basic assumption: It will be assumed that: The psychological and environmental aspects are the same for all subjects during the study. Every subject will exert the maximum effort during the study. Null hypothesis: There is no significant difference in C5-6 IVF width and height among each one of the 6 positions that Will be scanned by the 3DCT. There is no significant difference in pre & post 3 months measurements of C5-6 IVF width and height in neutral positions that will be measured by the 3DCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group will receive general stability exercises and neurodynamic mobilization only
Arm Title
CT guided opening mobilization of cervical intervertebral foreman
Arm Type
Experimental
Arm Description
Grade four manual therapy mobilization of cervical intervertebral foreman guided by 3 dimensions computed tomography (CT) as following : Determining the poper direction of cervical IVF by 3D CT. the patients lies in supine with his head resting comfortably at the position which cause maximum opening of the intervertebral foramen which has been determined by the 3D CT. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment. Passive mobilization techniques were progressed, utilizing unilateral posteroanterior mobilization of the mid and lower cervical spine and lateral gliding movements, in both directions, progressing in duration and intensity to allow a graded exposure of load. Sustained Natural Apophyseal Glides (SNAGS) were used mainly as self-treatment techniques to maintain the gains that achieved.
Intervention Type
Other
Intervention Name(s)
CT guided opening mobilization of cervical intervertebral foreman
Intervention Description
the patients lies in supine with his head resting comfortably at the position which cause maximum opening of the intervertebral foramen which has been determined by the 3D CT. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment. Passive mobilization techniques were progressed, utilizing unilateral posteroanterior mobilization of the mid and lower cervical spine and lateral gliding movements, in both directions, progressing in duration and intensity to allow a graded exposure of load. Sustained Natural Apophyseal Glides (SNAGS) were used mainly as self-treatment techniques to maintain the gains that achieved.
Primary Outcome Measure Information:
Title
Dimension of cervical intervertebral foreman.
Description
Width and Height of Cervical intervertebral foreman measured by 3 Dimensions Computed Tomography (CT.)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neck Disability index (NDI)
Description
Neck pain and function Questionnaires
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 1. Sever central canal stenosis and cervical myelopathy . 2. Sequestrated and migrated disc prolapse. 3. Acute onset of pain (pain less than three months). 4. Presence of active infection in cervical spine. 5. Postoperative cases. 6. Patient suspected to chemotherapy and radiotherapy. 7. Cervical instability.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud M Aly, PhD
Phone
01097246005
Email
dr3mpt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wael Shendy, Professor
Phone
01001006711
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameha H Hassan, professor
Organizational Affiliation
professor of physical therapy for neuromuscular disorders and its surgery
Official's Role
Study Chair
Facility Information:
Facility Name
ElRazzy Spine physical therapy clinics
City
Cairo
State/Province
Maadi
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mahmoud mohamed Aly, manager
Phone
01097246005
Email
dr3mpt@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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EFFECT OF CT GUIDED MOBILIZATION ON CERVICAL FOREMAN'S DIMENSIONS

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