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Documenting the changes in vertebral shape as children grow

Developing normative standards for vertebral morphology in children: a feasibility study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11264299
Enrollment
75
Registered
2023-05-24
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral morphology in children Musculoskeletal Diseases

Interventions

70 healthy growing children (17 girls and 18 boys aged 7 to 8 years, 18 girls aged 11 to 12 years and 17 boys aged 13 to 14 years) will be recruited from schools in Sheffield and Birmingham. Researche
Sheffield Children's Hospital for children from Sheffield schools and Birmingham Children's Hospital for children from Birmingham schools. The receptionists will contact the parents/guardians to arran

Sponsors

Sheffield Children's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy growing children from school in Sheffield and Birmingham 2. 35 children (17 girls) aged 7 to 8 years, 18 girls aged 11 to 12 years and 17 boys aged 13 to 14 years. Ages have been selected to represent the periods of rapid childhood growth by sex

Exclusion criteria

Exclusion criteria: 1. Ongoing chronic disease 2. Ongoing long-term steroid medication 3. Scoliosis or significant kyphosis 4. History (within preceding 3 years) of road traffic accident 5. History (within preceding 3 years) of back pain/stiffness (particularly morning stiffness) 6. History (within preceding 3 years) of investigation for unexplained fever, malaise, aches/pains 7. Abnormal VFA identified during the study (ACO will review all images to confirm normality. Assent/consent will be obtained from volunteers and parents/guardians to inform the child’s GP should any abnormality be detected, in order for the child to be appropriately referred and investigated)

Design outcomes

Primary

MeasureTime frame
1. Participant acceptance of attending hospital, measured using a non-validated questionnaire on Day 1 2. Recruitment rate, defined as the number of participants recruited per month over the 7-month recruitment period

Secondary

MeasureTime frame
Variability of vertebral morphometry in young children measured using analysis of variance for differences in anterior, middle and posterior vertebral heights by age and sex on Day 1

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026