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Adolescent Idiopathic Scoliosis (AIS)NCT06629948

Correlation Between the Cobb's Angle and the Forward Head Posture in Patients With Adolescent Idiopathic Scoliosis

An observational study of Adolescent Idiopathic Scoliosis (AIS) and Forward Head Posture, run by Cairo University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Purpose of This study to detect if there is correlation between the Cobb's angle and the forward head posture in patients with Adolescent Idiopathic Scoliosis. And if there is correlation between the Cobb's angle and the cervical sagittal curve angle in AIS. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
x ray and the cranio-cervical flexion test
Type of treatment
Medical device
How many people
34 participants
Where
1 siteEgypt
Study dates
Oct 2024to Apr 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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 10 to 18 years
  • All sexes
  • Child, Adult

Study population: Thirty four Male and female subjects with adolescent idiopathic scoliosis participating in this study will be assigned homogenously some of them with Cobb's angle below 45 degrees and others above 45 degrees (n=34) and they will sign a consent form.

Who may be able to join

  • 1- Patients with AIS. 2- Patient with forward head posture CVA less than 48 degress. (Fard et al .,2021) 3- Patients aged between 10 and 18 years, (Upasani et al., 2007). 4- Patients who underwent Posterioanterior (PA) and lateral X-ray radiography, and Cobb angle >10°.(Nasser et al.,2023) 5- Patients with Lenke types (1 to 6). 6- No previous spine surgery ((Wang, et al., 2017).

Who cannot join

  • 1- Patients with congenital scoliosis (including hemivertebrae, butterfly vertebrae, and failure of segmentation), (Shu-Man Han et al., 2022 and Nasser et al., 2023).
  • 2- Other developmental thoracic deformity (funnel chest etc.). 3- Scoliosis with definitive reasons (secondary to neurofibromatosis, Marfan syndrome, and syringomyelia).
  • 4- Patients with neurologic deficit or spondylolisthesis (Upasani et al., 2007).
  • 5- History of spinal trauma and infection, and metabolic bone disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mina Ezzat Aziz, Bachelor contact

0201211354070

menaezzat62@gmail.com

Egypt1 site

  • Cairo University

    Cairo

    Enas Fawzy Youssef, Professor

Other trials in Egypt

About this study

Purpose of This study to detect if there is correlation between the Cobb's angle and the forward head posture in patients with Adolescent Idiopathic Scoliosis.

And if there is correlation between the Cobb's angle and the cervical sagittal curve angle in AIS. And also if there is correlation between the Cobb's angle and deep flexors muscles endurance in AIS

Read the detailed description

The prevalence of sagittal profile imbalance in adolescent idiopathic scoliosis is not known exactly as little research is available in this context (Nasser et al., 2023) Thought based on previous studies that a forward head corrective exercise program combined with conventional rehabilitation improved three-dimensional scoliotic posture and functional status in patients with adolescent idiopathic scoliosis. (Alia Diab et al., 2012) Up to our knowledge there is no significant evidence that there is correlation between Craniovertebral angle (CVA) and idiopathic scoliosis by Cobb's angle.

So we need to make a simple assessment method of the severity of scoliosis and its impact on head position through a simpler method by observing the cervical curvature through photos for CVA, This can help to avoid unnecessary radiological examination. In addition, it also may help in paying the attention to the correction of cervical spines, head position and cervical muscles endurance during conservative treatment of scoliosis.

Also studying cervical sagittal alignment deformities will help in surgical operations to maintain or restore sagittal physiological curvature side by side with correction of coronal scoliosis angle in order to prevent adjacent segment degeneration after the fusion operation.

Being tested
x ray, the cranio-cervical flexion test
Keywords
Forward head, scoliosis, craniovertebral angle
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • x rayDevice

    whole spine x ray posterioanterior and lateral views

  • the cranio-cervical flexion testDiagnostic test

    measure of deep neck flexors muscles endurance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1- Measurement of Craniovertebral angle CVA

    We will measure The Craniovertebral angle by the photogrammetric method

    Measured: within 3 months from enrollment

  2. Measurement of Cobb's angle

    Measurement of Cobb's angle from whole spine xray

    Measured: within 3 months from enrollment

  3. Measurement of sagittal cervical curve angle

    Measurement of cervical spines sagittal curve from lateral view X-ray

    Measured: within 3 months from enrollment

  4. 4- Measurement of deep flexors muscle endurance.

    Activation and performance scores will be recorded.

    Measured: within 3 months from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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
34 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06629948
Sponsor's protocol ID
Forward head in AIS
Status last verified
Oct 2024
First submitted
4 Oct 2024
Last updated
8 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.

    PubMed 25269032

  • Latalski M, Danielewicz-Bromberek A, Fatyga M, Latalska M, Krober M, Zwolak P. Current insights into the aetiology of adolescent idiopathic scoliosis. Arch Orthop Trauma Surg. 2017 Oct;137(10):1327-1333. doi: 10.1007/s00402-017-2756-1. Epub 2017 Jul 14.

    PubMed 28710669

  • Yip CH, Chiu TT, Poon AT. The relationship between head posture and severity and disability of patients with neck pain. Man Ther. 2008 May;13(2):148-54. doi: 10.1016/j.math.2006.11.002. Epub 2007 Mar 23.

    PubMed 17368075

  • Wang L, Liu X. Cervical sagittal alignment in adolescent idiopathic scoliosis patients (Lenke type 1-6). J Orthop Sci. 2017 Mar;22(2):254-259. doi: 10.1016/j.jos.2016.12.006. Epub 2016 Dec 23.

    PubMed 28025024

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Idiopathic Scoliosis (AIS) and Forward Head Posture, 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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mina Ezzat Aziz, Bachelor (0201211354070, menaezzat62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1- Measurement of Craniovertebral angle CVA (time frame: within 3 months from enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629948, which also lists 4 linked publications.

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 8 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.

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