Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis.

Primary research question: Is night-time bracing (NTB) non-inferior to full-time bracing (FTB) in preventing curve progression to 50 degrees or more in children with adolescent idiopathic scoliosis (AIS) before skeletal maturity?

Background: FTB is routinely used in the UK to prevent progression of AIS to a point where surgery is required (Cobb angle greater than 50 degrees). Despite evidence to suggest FTB is more beneficial than observation alone, FTB is often not prescribed to patients and when it is, is poorly tolerated. NTB overcorrects the curve to a point which would not be possible in FTB and has been shown in numerous case-series studies to be similar to FTB, with improved patient compliance.

Aims and objectives: A) To determine if NTB is non inferior to FTB in reducing the risk of curve progression to 50 degrees; B) To determine if there is a difference in anxiety, depression and quality of life between NTB and FTB; C) To determine the patient’s and parent’s experience and satisfaction of the braces; D) To determine the effects of bracing on quality of life and curve progression up to two years after skeletal maturity; E) To evaluate the relative cost-effectiveness of NTB compared to FTB.

Methods: A pragmatic, multi-centre RCT where children aged 10 to 15 with AIS and a Cobb angle of between 20 and 40 degrees will be randomised to receive either FTB (n=390) or NTB (n=390). The primary outcome will be progression of the Cobb angle to 50 degrees before skeletal maturity (binary). Secondary outcomes will be collected over the duration of bracing (average 3-years) and then for up to 2-years post-skeletal maturity, and will include anxiety, depression, sleep disturbance, need for surgery, pain, compliance and quality of life.

An internal pilot during the first 18 months of the trial will assess the feasibility of recruitment, intervention delivery and data collection. A qualitative study will seek patient‘s and parent’s experience of the two bracing techniques.

Timelines for delivery: month (M) M1-M8: ethics approvals, RCT set-up; M9-M26: internal pilot and qualitative study; M27-M50: complete RCT recruitment; M51-M116: follow-up; M117-M122: analysis and write up.

Anticipated impact and dissemination: Patients requiring a brace could use NTB to significantly improve quality of life and other psychological effects of bracing in this population, whilst not increasing the need for surgery. Dissemination will occur via patient groups, professional bodies, direct interaction with NHS Trusts and commissioners, academic journal articles and conference presentations.