EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHYNCT05585372
EFFECT OF CT GUIDED MOBILIZATION ON CERVICAL FOREMAN'S DIMENSIONS
A study testing CT guided opening mobilization of cervical intervertebral foreman in people with EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY
- What is being tested?
- CT guided opening mobilization of cervical intervertebral foreman
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Wael Shendy, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
ElRazzy Spine physical therapy clinics
Cairo, Maadi, 11728
mahmoud mohamed Aly, manager, 01097246005, dr3mpt@yahoo.com
About this study
Official title: 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.
Read the 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.
- Being tested
- CT guided opening mobilization of cervical intervertebral foreman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT guided opening mobilization of cervical intervertebral foremanOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group will receive general stability exercises and neurodynamic mobilization only |
| CT guided opening mobilization of cervical intervertebral foreman | Experimental | Grade four manual therapy mobilization of cervical intervertebral foreman guided by 3 dimensions computed tomography (CT) as following :
1. Determining the poper direction of cervical IVF by 3D CT.
2. 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.
3. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment.
4. 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.
5. Sustained Natural Apophyseal Glides (SNAGS) were used mainly as self-treatment techniques to maintain the gains that achieved. Receives: Other: CT guided opening mobilization of cervical intervertebral foreman |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimension of cervical intervertebral foreman.
Width and Height of Cervical intervertebral foreman measured by 3 Dimensions Computed Tomography (CT.)
Measured: 3 months
Secondary outcomes (1)
Neck Disability index (NDI)
Neck pain and function Questionnaires
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Mar 2023
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHYStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Aly, Cairo University
- Investigators
- Sameha H Hassan, professor, Study chair, professor of physical therapy for neuromuscular disorders and its surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585372
- Sponsor's protocol ID
- CT guided C Sp F Mobilization.
- Status last verified
- Apr 2023
- First submitted
- 14 Oct 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF RADIOLOGICAL GUIDED MOBILIZATION ON CERVICAL INTERVERTEBRAL FORAMEN IN PATIENTS WITH CANAL STENOSIS
- ClinicalTrials.gov ID
- NCT05585372
- Acronym / sponsor ID
- CT guided C Sp F Mobilization.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group will receive general stability exercises and neurodynamic mobilization only |
| CT guided opening mobilization of cervical intervertebral foreman | Experimental | Other: CT guided opening mobilization of cervical intervertebral foremanGrade four manual therapy mobilization of cervical intervertebral foreman guided by 3 dimensions computed tomography (CT) as following : 1. Determining the poper direction of cervical IVF by 3D CT. 2. 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. 3. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment. 4. 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. 5. Sustained Natural Apophyseal Glides (SNAGS) were used mainly as self-treatment techniques to maintain the gains that achieved. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT guided opening mobilization of cervical intervertebral foreman1. 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. 2. cervical lateral glide from right to left for C5, C6 and C7, Grade IV 3 × 6 on each segment. 3. 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. 4. 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 |
Primary outcome
Dimension of cervical intervertebral foreman.
Time frame: 3 months
Width and Height of Cervical intervertebral foreman measured by 3 Dimensions Computed Tomography (CT.)
1 secondary outcome
Neck Disability index (NDI)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Shendy, Professor contact
Sameha H Hassan, professor study chair
professor of physical therapy for neuromuscular disorders and its surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT guided opening mobilization of cervical intervertebral foreman in people with EFFECT OF CT Guided Mobilization ON CERVICAL RADICULOPATHY, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Aly, PhD (01097246005, dr3mpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dimension of cervical intervertebral foreman. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.