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Scoliosis Idiopathic AdolescentNCT05682521

Scoliosis and Postural Deformity Evaluation in Famagusta Region Secondary Schools

An observational study of Scoliosis Idiopathic Adolescent, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to evaluate scoliosis and postural deformities in secondary school students in Famagusta region. Secondary school students who meet the inclusion criteria will be included in the study, which will be conducted in the form of screening in public and private schools in the Famagusta region of the… Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Scoliosis Idiopathic Adolescent
How many people
440 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2022to 1 Aug 2023
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 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Students between the ages of 10-15 studying at secondary schools in the Famagusta region will be included in the study.

Who may be able to join

  • Being between the ages of 10 - 15
  • Volunteering to participate in the study
  • Not having neuromuscular scoliosis

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eastern Mediterranean University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

    Mersin, Famagusta, 99450

Other trials in Turkey (Türkiye)

About this study

The aim of the study is to evaluate scoliosis and postural deformities in secondary school students in Famagusta region. Secondary school students who meet the inclusion criteria will be included in the study, which will be conducted in the form of screening in public and private schools in the Famagusta region of the Turkish Republic of Northern Cyprus. Sociodemographic information of the individuals will be obtained first. Then, Adam's forward bending test, trunk rotation angle with scoliometer, foot posture index and New York posture index will be evaluated. Evaluations will be made within a single day.

Read the detailed description

The term scoliosis originates from the ancient Greek word "scolios" (curvature) and was first used by Galen around AD 130-201. Scoliosis is a common three-dimensional deformity that causes severe postural impairment in advanced stages. It is generally defined as a curvature of the spine towards lateral flexion in the frontal plane and towards rotation in the transverse plane. Scoliosis is divided into idiopathic and non-idiopathic. Although the etiology of idiopathic scoliosis is not known exactly, it is thought that secondary causes such as genetic, hormonal and biomechanical factors and neuromuscular problems contribute to the development of scoliosis. Scoliosis; It is divided into different classes according to the age of onset, etiology, type and severity of the curvature. The most common type of scoliosis in the community is Adolescent Idiopathic Scoliosis (AIS). The Scoliosis Research Society defines adolescent idiopathic scoliosis (AIS) as a curve of Cobb angle ≥10°.

The incidence of adolescent idiopathic scoliosis (AIS) in healthy children is 2 - 4%. In Turkey, the prevalence of AIS has been reported as 2.3% in children aged 10-15 years. AIS begins in early puberty. The prevalence and severity of curvature are higher in girls than boys. While the prevalence of AIS aged 10-15 years in Turkey is 3.07% in girls, it is 1.49% in boys. Likewise, women are 8 times more prone to development of prognosis in curvature than men.

School screenings in scoliosis are very important in terms of early diagnosis, prevention or protection of deformity progression without surgical intervention. Scoliosis Research Society states that it is appropriate to perform annual routine screenings at the age of 10-14 years. Studies have been carried out in terms of early diagnosis of scoliosis worldwide and the importance of school screening as an early diagnosis method has been emphasized. According to recent literature studies, the prevalence of Adolescent Idiopathic Scoliosis (AIS) in school surveys has been shown within wide limits such as 0.47%-5.2%.

The aim of this study is that many school screening studies for scoliosis have been conducted in the literature both in the world and in Turkey, but there is no scoliosis and postural disorder screening data in TRNC. It is aimed to create an epidemiological database by calculating the prevalence of scoliosis in the 10-15 age group in secondary schools in the Famagusta region of the Turkish Republic of Northern Cyprus, as well as to evaluate postural deformities. It is expected that the data obtained will increase awareness about the incidence of scoliosis and contribute to the early diagnosis and treatment of curvature. Thus, in the long term, the development of severe spinal deformities and the medical problems caused by these deformities will be prevented.

Research Questions:

Research question 1: What is the incidence of scoliosis in secondary school students in Famagusta? Research question 2. What is the incidence of postural deformity in secondary school students in Famagusta?

Material and Method:

Secondary school students who meet the inclusion criteria will be included in the study, which will be conducted in the form of screening in public and private schools in the Famagusta region of the Turkish Republic of Northern Cyprus. Sociodemographic information of the individuals will be obtained first. Then, Adam's forward bending test, trunk rotation angle with scoliometer, foot posture index and New York posture index will be evaluated. Evaluations will be made within a single day. The sample size of the study was calculated using Epi InfoTM version 7. The initial sample size was calculated as 386 people in order to make an estimation in the 95% confidence interval under the assumptions that the population size of the study would be 2500, the expected prevalence rate would be 5%, the margin of error +/- 2%, and the pattern effect would be 1. Considering that there may be those who did not accept to participate in the study, this sample size was increased by 20% and the final sample size was calculated as 463 people.

Evaluations to be applied to the Subject:

Socio-demographic Form: In the first evaluation, socio-demographic informationof subjects such as age, height, body weight will be obtained through a form.

Adam's Forward Bend Test: This test is also known as the forward bend test. The test will be applied in a way that the boys are completely naked on the top and the girls are only athletes. With the shoes taken off, the feet together and the knee extended, the children will be asked to bend forward with their hips at a 90 degree angle, the arms will swing down freely and the palms will be facing each other. In case of scoliosis, it will be checked whether there is a rotational protrusion or asymmetry in the back as a result of the deformity of the spine in the ribs.

Body Rotation Angle Assessment: The person measuring with the scoliometer should sit in a chair behind the person to be evaluated. The person to be examined should keep his arms at head level and lean forward until the shoulders and hips are at the same level, and in this position, deviations in the scoliometer will be checked in the thoracic (T7 level), thoracolumbar (T12 level) and lumbar (L3 level) regions. Studies have shown that 7° deviation in the scoliometer corresponds to approximately 20° in the scoliosis Cobb angle of the spine. In the evaluations, students with scoliometer measurements of 7° and above will be informed about the suspicion of scoliosis and directed to the physician.

New York Posture Assessment Scale: In this evaluation system, postural changes that may occur in 13 different parts of the body are scored observationally.

Evaluation of Foot Postures: Foot posture will be assessed by the Foot PostureIndex (FPI).

Keywords
Scoliosis Idiopathic Adolescent, School screening, Prevalence, Scoliometer, Adams test

What is being measured

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

  1. Body Rotation Angle Evaluation with Scoliometer

    The individual is asked to bend forward 90 degrees by joining his hands together. Measurements will be made from the thoracic, thoracalumbar and lumbar regions with a scoliometer.

    Measured: 9 months

Secondary outcomes (3)
  1. Adam's Forward Bend Test

    Boys will be tested completely naked on top, and girls will be only athletes. With the shoes taken off, the feet together and the knee extended, the children will be asked to bend forward with their hips at a 90 degree angle, the arms will swing down freely and the palms will be facing each other. In case of scoliosis, it will be checked whether there is a rotational protrusion or asymmetry in the back as a result of the deformity of the spine in the ribs.

    Measured: 9 months

  2. New York Posture Rating Scale

    In this evaluation system, postural changes that may occur in 13 different parts of the body are scored observationally. Accordingly, five (5) points are given if the person's posture is correct, three (3) points if moderately impaired, and one (1) point if severely impaired. The total score obtained as a result of the test is a maximum of 65 and a minimum of 13. Standard evaluation criteria developed for this test are defined as "very good" if the total score is ≥45, "good" if 40-44, "moderate" if 30-39, "poor" if 20-29, and "poor" if it is ≤19.

    Measured: 9 months

  3. Foot Posture Index

    During the evaluation, individuals will be asked to stand still and in a relaxed position. The scale has 6 subheadings. The value of each question varies between -2 and +2 points. - values show supination, that is, increased MLA height, while + values show pronation, that is, decreased MLA height. As a result of the scale, the scores that individuals can get vary between -12 and +12. The six subheadings of the scale are palpation of the talus head, upper and lower slope of the lateral malleolus, calcaneal inversion-eversion, joint protrusion in the talonavicular region, MLA compliance, and forefoot abduction/adduction.

    Measured: 9 months

Timeline

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

  1. First posted12 Jan 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

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
Other
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682521
Sponsor's protocol ID
ETK00-2022-0220
Status last verified
Sep 2023
First submitted
25 Dec 2022
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Konieczny MR, Senyurt H, Krauspe R. Epidemiology of adolescent idiopathic scoliosis. J Child Orthop. 2013 Feb;7(1):3-9. doi: 10.1007/s11832-012-0457-4. Epub 2012 Dec 11.

    PubMed 24432052
  • Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.

    PubMed 18456103
  • Yaman O, Dalbayrak S. Idiopathic scoliosis. Turk Neurosurg. 2014;24(5):646-57. doi: 10.5137/1019-5149.JTN.8838-13.0.

    PubMed 25269032
  • Burwell RG, James NJ, Johnson F, Webb JK, Wilson YG. Standardised trunk asymmetry scores. A study of back contour in healthy school children. J Bone Joint Surg Br. 1983 Aug;65(4):452-63. doi: 10.1302/0301-620X.65B4.6874719.

    PubMed 6874719
  • Brooks HL, Azen SP, Gerberg E, Brooks R, Chan L. Scoliosis: A prospective epidemiological study. J Bone Joint Surg Am. 1975 Oct;57(7):968-72.

    PubMed 1194304
  • Jada A, Mackel CE, Hwang SW, Samdani AF, Stephen JH, Bennett JT, Baaj AA. Evaluation and management of adolescent idiopathic scoliosis: a review. Neurosurg Focus. 2017 Oct;43(4):E2. doi: 10.3171/2017.7.FOCUS17297.

    PubMed 28965447
  • Cheng JC, Castelein RM, Chu WC, Danielsson AJ, Dobbs MB, Grivas TB, Gurnett CA, Luk KD, Moreau A, Newton PO, Stokes IA, Weinstein SL, Burwell RG. Adolescent idiopathic scoliosis. Nat Rev Dis Primers. 2015 Sep 24;1:15030. doi: 10.1038/nrdp.2015.30.

    PubMed 27188385
  • Picault C, deMauroy JC, Mouilleseaux B, Diana G. Natural history of idiopathic scoliosis in girls and boys. Spine (Phila Pa 1976). 1986 Oct;11(8):777-8. doi: 10.1097/00007632-198610000-00004. No abstract available.

    PubMed 3810291
  • De Wilde L, Plasschaert F, Cattoir H, Uyttendaele D. Examination of the back using the Bunnell scoliometer in a Belgian school population around puberty. Acta Orthop Belg. 1998 Jun;64(2):136-43.

    PubMed 9689752
  • Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol). 2006 Jan;21(1):89-98. doi: 10.1016/j.clinbiomech.2005.08.002. Epub 2005 Sep 21.

    PubMed 16182419

Questions about this trial

What is this clinical trial studying?

An observational study of Scoliosis Idiopathic Adolescent, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

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 0 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: finished, as of the sponsor's last update on 3 Oct 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Body Rotation Angle Evaluation with Scoliometer (time frame: 9 months). 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 NCT05682521, which also lists 10 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 3 Oct 2023.

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