EFFECT OF CT GUIDED MOBILIZATION ON CERVICAL FOREMAN'S DIMENSIONS

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

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.

Study Overview

• Status: Recruiting
• Conditions: EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY
• Intervention / Treatment: Other: CT guided opening mobilization of cervical intervertebral foreman

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
8. IVF width & Hight will be measured from the 3D CT from each position for Right (Rt) & left (Lt) IVF.
9. 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:

1. The psychological and environmental aspects are the same for all subjects during the study.
2. Every subject will exert the maximum effort during the study.

Null hypothesis:

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud M Aly, PhD; Phone Number: 01097246005; Email: dr3mpt@gmail.com
• Study Contact Backup: Name: Wael Shendy, Professor; Phone Number: 01001006711

Study Locations

• Egypt
  • Maadi
    • Cairo, Maadi, Egypt, 11728
      • Recruiting
      • ElRazzy Spine physical therapy clinics
      • Contact: mahmoud mohamed Aly, manager; Phone Number: 01097246005; Email: dr3mpt@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; The control group will receive general stability exercises and neurodynamic mobilization only
Experimental: CT guided opening mobilization of cervical intervertebral foreman; 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.	Other: CT guided opening mobilization of cervical intervertebral foreman; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dimension of cervical intervertebral foreman.	Width and Height of Cervical intervertebral foreman measured by 3 Dimensions Computed Tomography (CT.)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability index (NDI)	Neck pain and function Questionnaires	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Sameha H Hassan, professor, professor of physical therapy for neuromuscular disorders and its surgery

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Anticipated): August 20, 2023
• Study Completion (Anticipated): September 20, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: CT guided C Sp F Mobilization.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No