ScoliosisNCT07433894
Scoliosis and Functional Outcomes in Children With Juvenile Idiopathic Arthritis
An observational study of Scoliosis, run by Istanbul University.
Trial summary
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may affect musculoskeletal development and posture in children. Spinal involvement, including scoliosis, is not routinely evaluated in clinical practice despite its potential impact on functional status and quality of life. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2026
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of children and adolescents aged 8-18 years diagnosed with juvenile idiopathic arthritis (JIA) according to ILAR criteria and followed up at a tertiary pediatric rheumatology center. Participants will be recruited consecutively during routine outpatient visits. The aim of the study is to evaluate the prevalence and severity of scoliosis, as defined by Cobb angle measurements on physical examination and, if necessary, standing spinal radiographs, and to examine its relationship with clinical and functional parameters. Both patients with and without scoliosis will be included in the study.
Who may be able to join
- Age between 8 and 18 years at the time of enrollment
- Diagnosis of juvenile idiopathic arthritis (JIA) according to ILAR criteria
- Written informed consent obtained from parent/legal guardian and assent from the child/adolescent, when appropriate
Who cannot join
- Known scoliosis due to non-JIA causes (e.g., congenital vertebral anomalies, neuromuscular disorders, or syndromic scoliosis)
- History of prior spinal surgery or current brace treatment for scoliosis
- History of significant spinal trauma or spinal infection/tumor affecting spinal alignment
- Presence of coexisting chronic conditions that significantly affect posture, gait, or functional testing (e.g., severe neurologic impairment) and may confound assessments
- Inability to undergo required assessments (e.g., inability to stand for radiographs or complete functional measures)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comprehensive Evaluation of Scoliosis and Its Association With Functional Status, Postural Alignment, and Disease Activity in Children With Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may affect musculoskeletal development and posture in children. Spinal involvement, including scoliosis, is not routinely evaluated in clinical practice despite its potential impact on functional status and quality of life.
This cross-sectional study aims to assess the presence of scoliosis in children with JIA and to investigate its association with functional status, postural alignment, and disease activity. Clinical and functional parameters will be analyzed to better understand the impact of spinal deformities in this population.
Read the detailed description
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may negatively affect musculoskeletal development, posture, and overall physical function in children. Although peripheral joint involvement is well characterized, axial and postural abnormalities, including scoliosis, are not routinely assessed during follow-up despite their potential clinical significance.
This cross-sectional study aims to evaluate the presence of scoliosis in children with JIA and to investigate its relationship with disease activity, functional status, pain, and postural alignment. Comprehensive clinical assessments, including physical examination, disease activity scores, and functional evaluation tools, will be performed. Where applicable, postural analysis and imaging findings will also be considered.
By identifying the frequency and clinical impact of scoliosis in JIA, this study seeks to improve awareness of spinal involvement and to provide a basis for early recognition and multidisciplinary management strategies, including targeted physiotherapy interventions.
- Conditions
- Scoliosis
- Keywords
- Juvenile Idiopathic Arthritis, Scoliosis, Functional Outcomes, Postural Alignment, Pediatric Rheumatology
- Medical subject headings
- Scoliosis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JIA Patients With Scoliosis | Children diagnosed with juvenile idiopathic arthritis (JIA) who have scoliosis, defined by a Cobb angle of ≥10 degrees on standing spinal radiographs. Clinical characteristics, disease activity parameters, and functional assessments including postural and plantar pressure analyses will be evaluated. No intervention will be applied; this group will be observationally assessed. | |
| JIA Patients Without Scoliosis | Children diagnosed with juvenile idiopathic arthritis (JIA) without evidence of scoliosis (Cobb angle <10 degrees). Participants will undergo the same clinical, laboratory (if applicable), and functional assessments as the scoliosis group. This is an observational group with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Scoliosis in Children With Juvenile Idiopathic Arthritis
Proportion of participants with scoliosis, defined as a Cobb angle ≥10° measured on standing spinal radiographs.
Measured: At baseline (single study visit)
Secondary outcomes (2)
Scoliosis Severity (Cobb Angle)
Cobb angle (degrees) measured on standing spinal radiographs. Scoliosis defined as Cobb angle ≥10°.
Measured: At baseline (single study visit)
Health-Related Quality of Life (PedsQL)
Health-related quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) total score (and physical and psychosocial subscale scores, if available). Scores are transformed to a 0-100 scale (range: 0-100), with higher scores indicating better health-related quality of life.
Measured: At baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 Istanbul 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengisu Menentoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433894
- Sponsor's protocol ID
- Jia-scoliosis
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request after publication, subject to institutional policies, ethical approvals, and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Scoliosis and Its Association With Functional Status, Postural Alignment, and Disease Activity in Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT07433894
- Acronym / sponsor ID
- Jia-scoliosis
- Conditions
- Scoliosis
- Keywords
- Juvenile Idiopathic Arthritis, Scoliosis, Functional Outcomes, Postural Alignment, Pediatric Rheumatology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may affect musculoskeletal development and posture in children. Spinal involvement, including scoliosis, is not routinely evaluated in clinical practice despite its potential impact on functional status and quality of life.
This cross-sectional study aims to assess the presence of scoliosis in children with JIA and to investigate its association with functional status, postural alignment, and disease activity. Clinical and functional parameters will be analyzed to better understand the impact of spinal deformities in this population.
Detailed description
Juvenile idiopathic arthritis (JIA) is a chronic inflammatory disease that may negatively affect musculoskeletal development, posture, and overall physical function in children. Although peripheral joint involvement is well characterized, axial and postural abnormalities, including scoliosis, are not routinely assessed during follow-up despite their potential clinical significance.
This cross-sectional study aims to evaluate the presence of scoliosis in children with JIA and to investigate its relationship with disease activity, functional status, pain, and postural alignment. Comprehensive clinical assessments, including physical examination, disease activity scores, and functional evaluation tools, will be performed. Where applicable, postural analysis and imaging findings will also be considered.
By identifying the frequency and clinical impact of scoliosis in JIA, this study seeks to improve awareness of spinal involvement and to provide a basis for early recognition and multidisciplinary management strategies, including targeted physiotherapy interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JIA Patients With Scoliosis | – | –Children diagnosed with juvenile idiopathic arthritis (JIA) who have scoliosis, defined by a Cobb angle of ≥10 degrees on standing spinal radiographs. Clinical characteristics, disease activity parameters, and functional assessments including postural and plantar pressure analyses will be evaluated. No intervention will be applied; this group will be observationally assessed. |
| JIA Patients Without Scoliosis | – | –Children diagnosed with juvenile idiopathic arthritis (JIA) without evidence of scoliosis (Cobb angle <10 degrees). Participants will undergo the same clinical, laboratory (if applicable), and functional assessments as the scoliosis group. This is an observational group with no intervention. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children and adolescents aged 8-18 years diagnosed with juvenile idiopathic arthritis (JIA) according to ILAR criteria and followed up at a tertiary pediatric rheumatology center. Participants will be recruited consecutively during routine outpatient visits. The aim of the study is to evaluate the prevalence and severity of scoliosis, as defined by Cobb angle measurements on physical examination and, if necessary, standing spinal radiographs, and to examine its relationship with clinical and functional parameters. Both patients with and without scoliosis will be included in the study.
Key inclusion criteria (3 listed)
- Age between 8 and 18 years at the time of enrollment
- Diagnosis of juvenile idiopathic arthritis (JIA) according to ILAR criteria
- Written informed consent obtained from parent/legal guardian and assent from the child/adolescent, when appropriate
Key exclusion criteria (5 listed)
- Known scoliosis due to non-JIA causes (e.g., congenital vertebral anomalies, neuromuscular disorders, or syndromic scoliosis)
- History of prior spinal surgery or current brace treatment for scoliosis
- History of significant spinal trauma or spinal infection/tumor affecting spinal alignment
- Presence of coexisting chronic conditions that significantly affect posture, gait, or functional testing (e.g., severe neurologic impairment) and may confound assessments
- Inability to undergo required assessments (e.g., inability to stand for radiographs or complete functional measures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Scoliosis in Children With Juvenile Idiopathic Arthritis
Time frame: At baseline (single study visit)
Proportion of participants with scoliosis, defined as a Cobb angle ≥10° measured on standing spinal radiographs.
2 secondary outcomes
Scoliosis Severity (Cobb Angle)
Time frame: At baseline (single study visit)
Health-Related Quality of Life (PedsQL)
Time frame: At baseline (single study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request after publication, subject to institutional policies, ethical approvals, and data protection regulations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Istanbul University.
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 5 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Bengisu Menentoğlu (+905359523337, bengisusanisoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Scoliosis in Children With Juvenile Idiopathic Arthritis (time frame: At baseline (single study visit)). 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 27 Feb 2026.