Cervical RadiculopathyNCT06220799
Impact of Craniovertebral Angle on Dizziness and Risk of Falling in Cervical Radiculopathy Patients
An observational study of Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Cervical Radiculopathy
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2023to 29 Jan 2024
- Phase
- Observational
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will be enrolled in this study. Patients will be assigned into two groups (study and control groups) . The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA =more than 49°). Patients in group I were diagnosed as patients with chronic cervical radiculopathy with forward head posture (FHP) based on careful clinical evaluation by the neurologist . The patients will be recruited from the faculty of Physical Therapy, Cairo University, and private clinic in cairo .
Who may be able to join
- The Patients will include if they have the following:
- Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will participate in the study (twenty five with forward head posture (FHP) , and twenty five without forward head posture (FHP) ).
- The duration of the disease (cervical radiculopathy)is more than 6 months.
- The age ranged from 35 to 50 years old.
- Mild to moderate neck pain on visual analogue scale .
- Pain and dizziness lasting for 3-6 months.
- subjective dizziness experienced in conjunction with cervical pain, movement, stiffness, or particular postures.
Who cannot join
- The Patients will exclude if they exhibit any of the following:
- Cervical myelopathy.
- Cervical myelo-radiculopathy.
- Acute cervical radiculopathy.
- Diabetic neuropathy.
- Previous cervical surgery.
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- Cervical trauma.
- Deformities in the cervical spine .
- Rheumatoid arthritis.
- Any tumours and infection involving the cervical spine .
- Patients with a history of neuromuscular disorders.
- precise diagnosis of either central dizziness (due to cerebrovascular disorders related to the vertebrobasilar circulation, migraine, multiple sclerosis, tumours of the posterior fossa, neurodegenerative disorders, some drugs, and psychiatric disorders) or peripheral dizziness( due to a problem in the part of the inner ear that controls balance. These areas are called the vestibular labyrinth, or semicircular canals. The problem may also involve the vestibular nerve. This is the nerve between the inner ear and the brain stem).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Labs at Cairo University
Dokki, Giza Governorate, 12612
Faculty of Physical Therapy Labs at Cairo University
Sara Aboud, Teaching assistant, +201003194513, saraaboud1994@gmail.com
About this study
Official title: Impact of the Craniovertebral Angle on the Cervicogenic Dizziness and the Risk of Falling in Patients With Cervical Radiculopathy
-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? The participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales .
Researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .
- Conditions
- Cervical Radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The Study group (GI) | The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). | |
| The Control group (GII) | The Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA = more than 49). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral angle (CVA)
Taking photos from lateral view then craniovertebral angle measured by Kinovea software program.
Measured: 20 minutes
Cervical joint position error .
Cervical joint position error via the CROM device,through the neutral head repositioning test (NHR) and the target head repositioning test (THR).
Measured: 40 minutes
Cervicogenic dizziness.
Cervicogenic dizziness via score of Dizziness Handicap Inventory Questionnaire(DHI).
Measured: 10 minutes
The risk of falling.
The risk of falling assessed by Berg Balance Scale(BBS) .
Measured: 20 minutes
The fear of falling.
The fear of falling assessed by Fall Efficacy Scale-International(FES-I).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start4 Sep 2023
- Primary completion29 Jan 2024 (estimated)
- Study completion29 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdelrahman Elsayed Hassan Aboud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220799
- Sponsor's protocol ID
- P.T.REC/012/004743
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Craniovertebral Angle on the Cervicogenic Dizziness and the Risk of Falling in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT06220799
- Acronym / sponsor ID
- P.T.REC/012/004743
- Conditions
- Cervical Radiculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 29 Jan 2024 (estimated)
- Study completion
- 29 Jan 2024 (estimated)
- First posted
- 24 Jan 2024 (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.
-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? The participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales .
Researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Study group (GI) | – | –The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). |
| The Control group (GII) | – | –The Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA = more than 49). |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will be enrolled in this study. Patients will be assigned into two groups (study and control groups) . The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA =more than 49°). Patients in group I were diagnosed as patients with chronic cervical radiculopathy with forward head posture (FHP) based on careful clinical evaluation by the neurologist . The patients will be recruited from the faculty of Physical Therapy, Cairo University, and private clinic in cairo .
Key inclusion criteria (7 listed)
- The Patients will include if they have the following:
Key exclusion criteria (12 listed)
- The Patients will exclude if they exhibit any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Craniovertebral angle (CVA)
Time frame: 20 minutes
Taking photos from lateral view then craniovertebral angle measured by Kinovea software program.
Cervical joint position error .
Time frame: 40 minutes
Cervical joint position error via the CROM device,through the neutral head repositioning test (NHR) and the target head repositioning test (THR).
Cervicogenic dizziness.
Time frame: 10 minutes
Cervicogenic dizziness via score of Dizziness Handicap Inventory Questionnaire(DHI).
The risk of falling.
Time frame: 20 minutes
The risk of falling assessed by Berg Balance Scale(BBS) .
The fear of falling.
Time frame: 10 minutes
The fear of falling assessed by Fall Efficacy Scale-International(FES-I).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 7 inclusion and 12 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 24 Jan 2024. 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 Sara Aboud, Teaching Assistant (+201003194513, saraaboud1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniovertebral angle (CVA) (time frame: 20 minutes). The study lists 5 primary outcomes in all. 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 24 Jan 2024.