Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Recruiting now · Not applicable

Conditions studied: Idiopathic Scoliosis

In brief

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Key facts

Study ID

NCT04805437

Run by

Karolinska Institutet

People needed

170

Starts

2021-04-30

Expected to finish

2037-04-01

Last updated by the study team

2025-02-21

Who can join

Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cobb 25-40 degrees
• Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
• Menarche status maximum one year in females
• Aged 9-17 years
• No previous brace treatment or surgery for scoliosis
• Apex of the primary curve at T7 or caudal

You may not qualify if…

• Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
• Previous spine surgery

Where it is running

• Karolinska university hospital — Stockholm, Sweden (enrolling)
• Linköping university hospital — Linköping, Sweden

Full record on ClinicalTrials.gov

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