Sideways curvature of the spine (scoliosis) Musculoskeletal Diseases Scoliosis
Conditions
Interventions
Current intervention as of 30/05/2023:
The trial is being conducted in 22 large NHS trusts. Patients with AIS will be identified within the clinic setting - these will either be new patients or patien
Sponsors
Sheffield Children's NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
10 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Children (10–15 years old inclusive) with a diagnosis of AIS; (some patients recruited at age 15 may be 19 years old by the time they have completed their 2 years after skeletal maturity follow-up) 2. Risser 0, 1 or 2 3. Curve size (Cobb angle) between 20 and 40 degrees inclusive at baseline 4. Curve apex at or below T7 5. Participants and their parent/legal guardian must have a good understanding of the English language to ensure they understand what is required as part of the trial Added 14/05/2024: BASIS 2: 1. Participants enrolled on the BASIS study 2. RAC confirms skeletal maturity (Risser 4 in girls, Risser 5 in boys) with a Cobb angle less than 50o
Exclusion criteria
Exclusion criteria: 1. Secondary causes of scoliosis (i.e. neurological abnormalities and abnormal imaging) 2. Previous bracing or spinal surgery 3. Child or parent is unable to adhere to trial procedures or complete follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Curve progression is measured using the Cobb angle (measured from x-ray), every 6 months, before skeletal maturity, and then at 1 and 2 years post skeletal maturity. Added 14/05/2024: BASIS 2: Curve progression from baseline to 2 years after skeletal maturity, in degrees. These will be assessed by the Central Measurement Team. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life is measured using the Scoliosis Research Society 22 questionnaire, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 2. Health related quality of life is measured using the CHU9D questionnaire, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 3. Psychological effects of bracing is measured using the Bad Sobernheim Stress Questionnaire questionnaire, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 4. Quality of life is measured using the Revised Children's Anxiety and Depression Scale (RCADS 25) questionnaire, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 5. Sleep disturbance is measured using the PROMIS Paediatric Sleep Disturbance Short Form 4a tool, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 6. Sleep-related impairment is measured using the PROMIS Paediatric Sleep Related Impairment Short Form 4a tool, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 7. Patient satisfaction with their brace treatment is measured using the Modified Client Satisfaction with Device module of the Orthotics and Prosthetics Users' Survey (CSD-OPUS) questionnaire, annually. 8. Education information and attainment is measured using a bespoke questionnaire, once, after the patient has completed their GCSEs (or equivalent). 9. Patient cost is measured using a bespoke questionnaire to the parents, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 10. Healthcare resource use is measured using a bespoke questionnaire to the parents, every 6 months until skeletal maturity, and then at 1 and 2 years post skeletal maturity. 11. School attendance is measured using a bespoke questionnaire to the parents, every 6 months until skeletal maturity, and then at 1 and 2 years post skel | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLizzie Swaby
Outcome results
None listed