Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study
Research type
Research Study
Full title
Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis
IRAS ID
291133
Contact name
Ashley Cole
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
Duration of Study in the UK
10 years, 1 months, 28 days
Research summary
Scoliosis is a condition affecting children where the spine twists and curves to the side, often developing between the ages of 10 and 15. Doctors try to prevent the curve becoming too large, as this causes distress due to appearance, and problems into adulthood (back pain and problems with the heart/lungs). A brace may be worn in order to stop the curve worsening, but rarely improving it. The most common type of brace, “full-time brace”, is recommended to be worn for at least 20 hours a day, and evidence suggests it can work. The alternative is a “night-time brace”, which is only worn in bed at night, and aims to push the curve to make it straighter overnight, though the evidence for its benefit less clear. Night-time braces can interfere less with patients’ usual activities. This study will compare night-time braces with the full-time brace and will find out patients’ experiences of the two.
Children with scoliosis who have not previously received bracing will be invited to take part, and will be randomly allocated to receive either a full time brace, or a night-time only brace. Patients will be followed up with regular appointments and back x-rays, and will remain in brace until they have finished growing or need to have surgery. After bracing is stopped, patients will have further clinic visits at 1 and 2 years. Interviews will also take place with some participating families to understand their experiences of bracing.
Two patient groups and an online survey of Scoliosis Association UK (SAUK) members have reviewed the study and feel this is a relevant and important question. The groups have inputted into the design of the study, and we will continue to work closely with the group during the study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0038
Date of REC Opinion
27 Mar 2021
REC opinion
Favourable Opinion