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.
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
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Forward Head Posture
- 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
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.
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- Measurement of Craniovertebral angle CVA
We will measure The Craniovertebral angle by the photogrammetric method
Measured: within 3 months from enrollment
Measurement of Cobb's angle
Measurement of Cobb's angle from whole spine xray
Measured: within 3 months from enrollment
Measurement of sagittal cervical curve angle
Measurement of cervical spines sagittal curve from lateral view X-ray
Measured: within 3 months from enrollment
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.
- First posted8 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Ezzat Ibrahim Aziz, Cairo University
- Investigators
- Enas Fawzy Youssef, Professor, Principal investigator, Professor and chairperson of Department of Orthopaedic Physical Therapy for Musculoskeletal Disorders and its Surgery Faculty of Physical Therapy Cairo University
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 25269032Latalski 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 28710669Yip 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 17368075Wang 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