Back Deformity in Adolescents Students | NCT04547647

Studies
Back Deformity in Adolescents Students

NCT04547647

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 14, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Back Disorder

Interventions

X- Ray

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2020Estimated

Primary Completion Date

Oct 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Sep 30, 2019

First Submission Date that Met QC Criteria

Sep 8, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2020

Last Update Posted Date

Sep 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Determine the prevalence of scoliosis and kyphosis among male adolescents in preparatory and secondary governmental schools in El Kharga city.
To identify factors affecting aetiology and morphology of scoliosis and kyphosis among male adolescents in governmental preparatory and secondary schools in El Kharga city.
To assess the effect of scoliosis and kyphosis among male adolescents in governmental preparatory and secondary schools in El Kharga city on related life style aspects.

Detailed Description

The anterior and posterior curves of concavity are part of the physiological position of the spinal column, and are represented by cervical lordosis, thoracic kyphosis, lumbar lordosis, and new sacral and coccygeal kyphosis. Despite all these curves, the spinal column should work mechanically as a straight and rigid axis to withstand stress, and should be functionally flexible in order to allow movement. This mix of opposite behaviors (rigidness and flexibility) is the result of a complex stabilization system formed by muscles that contract and relax harmonically and absorb any impact exerted on the spinal column structure. Biomechanically speaking, the spinal column influences and is influenced by positioning and stress of the pelvic and scapular belts, and upper and lower limbs, respectively. Postural deformities and alterations should not be evaluated only in terms of bone structure, but also in terms of the functional assembly represented by the spinal column [2].

Adolescence is a stage of fast physical development in which the nervous system and musculoskeletal system have yet to fully develop. Changes in the physical morphology of the spine are known to cause musculoskeletal system conditions, such as non-specific back pain. Moreover, the spinal morphology as scoliosis and kyphosis.

With early identification and intervention, scoliosis may be prevented from progressing, so that it does not interfere with mobility, activity or comfort. Scoliosis has a large percentage that remains asymptomatic,[4] Therefore the feasibility of screening is worthwhile

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
X- Ray	Radiation	X-Ray with A-P and lateral view of the whole spine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire	Self administrated questionnaire	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male students from the 2nd and 3rd preparatory levels and 1st secondary level

Exclusion Criteria:

female students

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Male students from the 2nd and 3rd preparatory levels and 1st secondary level will be included.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
esraa ES saleh	Contact	01007769293		esraa.tulib@yahoo.com
. Dalia Galal	Contact	01007120821

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28439404	Background	Theroux J, Stomski N, Hodgetts CJ, Ballard A, Khadra C, Le May S, Labelle H. Prevalence of low back pain in adolescents with idiopathic scoliosis: a systematic review. Chiropr Man Therap. 2017 Apr 20;25:10. doi: 10.1186/s12998-017-0143-1. eCollection 2017.
28234252	Background	Feng Q, Jiang C, Zhou Y, Huang Y, Zhang M. Relationship between spinal morphology and function and adolescent non-specific back pain: A cross-sectional study. J Back Musculoskelet Rehabil. 2017;30(3):625-633. doi: 10.3233/BMR-160544.

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena