Documenting the changes in vertebral shape as children grow

Not Applicable

• Conditions: Musculoskeletal Diseases; Vertebral morphology in children

• Registration Number: ISRCTN11264299
• Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-24
• Last Update Posted: 15 April 2024
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 75

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

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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