Children, OnlyNCT06255574
Correlation Between Cervical Spine Sagittal Alignment and Functional Disability in Preparatory School Students With Mechanical Cervical Pain
An observational study of Children, Only, run by Benha University.
Trial summary
Neck pain is a major public health concern that has been extensively studied in adults but not in children and adolescents. Mechanical neck pain became prevalent among children and adolescents, and has its impacts on functional ability. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Children, Only
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Mar 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 12 to 15 years
- All sexes
- Child
Study population: Preparatory school age students
Who may be able to join
- Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.
Who cannot join
- Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain
About this study
Neck pain is a major public health concern that has been extensively studied in adults but not in children and adolescents. Mechanical neck pain became prevalent among children and adolescents, and has its impacts on functional ability.
This study is aiming to investigate the correlation between Cervical spine sagittal alignment parameter (cranio-cervical angle) and functional disability in preparatory school students with mechanical cervical pain.
Read the detailed description
- Correlational study between cranio-cervical angles and functional disability in students with mechanical cervical pain.
- Inclusion Criteria Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.
- exclusion criteria Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain
- Conditions
- Children, Only
- Keywords
- cervical spine, sagittal alignment, functional disability, preparatory school children, mechanical cervical pain
What is being measured
The primary outcome is the main question the study is designed to answer.
● cervico cranial angle by X-ray device
● X-ray device: (Toshiba Rotande unite model DRX3724 HD/2009 will be used.
Measured: one hour
Functional neck status
Functional status will be evaluated by Neck Disability index (NDI).
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Helmy Koura, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255574
- Sponsor's protocol ID
- PT.BU.EC.4
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cervical Spine Sagittal Alignment and Functional Disability in Preparatory School Students With Mechanical Cervical Pain
- ClinicalTrials.gov ID
- NCT06255574
- Acronym / sponsor ID
- PT.BU.EC.4
- Conditions
- Children, Only
- Keywords
- cervical spine, sagittal alignment, functional disability, preparatory school children, mechanical cervical pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Feb 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.
Neck pain is a major public health concern that has been extensively studied in adults but not in children and adolescents. Mechanical neck pain became prevalent among children and adolescents, and has its impacts on functional ability.
This study is aiming to investigate the correlation between Cervical spine sagittal alignment parameter (cranio-cervical angle) and functional disability in preparatory school students with mechanical cervical pain.
Detailed description
- Correlational study between cranio-cervical angles and functional disability in students with mechanical cervical pain.
- Inclusion Criteria Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.
- exclusion criteria Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Preparatory school age students
Key inclusion criteria (1 listed)
- Age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months.
Key exclusion criteria (1 listed)
- Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain
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
● cervico cranial angle by X-ray device
Time frame: one hour
● X-ray device: (Toshiba Rotande unite model DRX3724 HD/2009 will be used.
Functional neck status
Time frame: one hour
Functional status will be evaluated by Neck Disability index (NDI).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Children, Only, run by Benha University.
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 1 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
● cervico cranial angle by X-ray device (time frame: one hour). The study lists 2 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 13 Feb 2024.