ScoliosisNCT03894865
Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
A study testing procedure1 and procedure2 in people with Scoliosis, run by Cairo University at 1 site in Egypt.
Trial summary
Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. Read more about this study
- Who is it for?
- Ages 10 to 15 years, men only
- Conditions the study is for
- Scoliosis
- What is being tested?
- procedure1 and procedure2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Jul 2019
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Age range from 10 to 15 years.
- Males students.
- Students who have structural scoliosis.
Who cannot join
- Congenital deformities.
- Recent fracture and there is a fixation in the upper or the lower extremities
- Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
- Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect, and Spina-bifida).
Trial locations and contacts
1 site in 1 country.
About this study
Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. This also will guide another clinician to search for the cause of these posture deformities and to concentrate screening for special areas with special cultures.
Read the detailed description
Scoliosis may have an impact on the Egyptian society as children between 10-15 years old represent 9.5 % of the population which is the third large category appendix (3). So without the early detection of adolescent idiopathic scoliosis for that age group, bad impacts will be implemented for Egyptian society by causing disabilities and psychological problems for these children.
The early detection of scoliosis is of a great importance as curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Scoliosis has a bad effect on cosmetic appearance, quality of life, Psychological well-being, disability, back Pain, breathing function. It may also progress in adulthood and need further treatment. So a multidimensional and comprehensive evaluation of scoliosis patients is necessary to design a complete therapeutic approach.
- Conditions
- Scoliosis
- Being tested
- procedure1, procedure2
- Keywords
- scoliosis, prevalence, screening, Egypt
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedure1Other
Also called Adam's forward bend test
The students will be asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. if there was scoliosis the rib cage rotated and a hump appeared. Positive test indicated the presence of a rib hump and negative if there was any hump appeared
procedure2Other
Also called Angle of trunk rotation
Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| urban school | Experimental | Male students from selected urban schools undergo screening for idiopathic scoliosis Receives: Other: procedure1; Other: procedure2 |
| countryside schools | Experimental | Male students from selected countryside schools undergo screening for idiopathic scoliosis Receives: Other: procedure1; Other: procedure2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Adam's forward bending test
Proportion of patients with a positive Adam's forward bending test
Measured: 10 minutes
degree of trunk rotation
scoliometer HD reading >7 degrees (=>20 degrees Cobb angle) Proportion of patients with more than 7 degree
Measured: 15 minutes
Secondary outcomes (1)
screening
percentage of childerns with idiopathic scoliosis
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karima Abdelaty Hassan, Cairo University
- Investigators
- karima A Hassan, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894865
- Sponsor's protocol ID
- scoliosis in Egypt
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Prevalence of Adolescent Idiopathic Scoliosis in Selected Urban and Countryside Schools in Egypt
- ClinicalTrials.gov ID
- NCT03894865
- Acronym / sponsor ID
- scoliosis in Egypt
- Conditions
- Scoliosis
- Keywords
- scoliosis, prevalence, screening, Egypt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 29 Mar 2019 (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.
Early detection of scoliosis and determination of which areas are more affected urban or countryside will help in early management. Also, this will guide the government and the community for early intervention to decrease the factors that leads to this postural abnormality. This also will guide another clinician to search for the cause of these posture deformities and to concentrate screening for special areas with special cultures.
Detailed description
Scoliosis may have an impact on the Egyptian society as children between 10-15 years old represent 9.5 % of the population which is the third large category appendix (3). So without the early detection of adolescent idiopathic scoliosis for that age group, bad impacts will be implemented for Egyptian society by causing disabilities and psychological problems for these children.
The early detection of scoliosis is of a great importance as curve detection before skeletal maturation gives a good opportunity for early treatment or prevention of curve progression. Scoliosis has a bad effect on cosmetic appearance, quality of life, Psychological well-being, disability, back Pain, breathing function. It may also progress in adulthood and need further treatment. So a multidimensional and comprehensive evaluation of scoliosis patients is necessary to design a complete therapeutic approach.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urban school | Experimental | Other: procedure1, Other: procedure2Male students from selected urban schools undergo screening for idiopathic scoliosis |
| countryside schools | Experimental | Other: procedure1, Other: procedure2Male students from selected countryside schools undergo screening for idiopathic scoliosis |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age range from 10 to 15 years.
- Males students.
- Students who have structural scoliosis.
Key exclusion criteria (4 listed)
- Congenital deformities.
- Recent fracture and there is a fixation in the upper or the lower extremities
- Neuromuscular disorder (Cerebral palsy and spinal muscle atrophy).
- Syndromic disorders (Muscular dystrophy, Osteogenesis imperfect, and Spina-bifida).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procedure1Also: Adam's forward bend testThe students will be asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. if there was scoliosis the rib cage rotated and a hump appeared. Positive test indicated the presence of a rib hump and negative if there was any hump appeared | Other | countryside schools, urban school |
| procedure2Also: Angle of trunk rotationMeasurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application. | Other | countryside schools, urban school |
Primary outcome
Positive Adam's forward bending test
Time frame: 10 minutes
Proportion of patients with a positive Adam's forward bending test
degree of trunk rotation
Time frame: 15 minutes
scoliometer HD reading >7 degrees (=>20 degrees Cobb angle) Proportion of patients with more than 7 degree
1 secondary outcome
screening
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
karima A Hassan, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procedure1 and procedure2 in people with Scoliosis, 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 3 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: finished, as of the sponsor's last update on 30 Jul 2019. 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?
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?
Positive Adam's forward bending test (time frame: 10 minutes). 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 30 Jul 2019.