Title: Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis.
Funder: Department of Health and Social Care

Abstract: Background_x000D_ Scoliosis is a condition that affects children where the spine twists and curves to the side. It develops when the child is growing, usually between the ages of 10 and 15 years. Doctors try to prevent the curve becoming too large, as large curves cause distress because of their appearance and can cause problems into adulthood (back pain and problems with the heart/lungs). In order to stop the curve worsening a brace may be worn which reduces the chance of the curve getting bigger, but rarely improves it. There are different types of brace. The most common type of brace is recommended to be worn for at least 20 hours a day, known as “full-time brace”. This holds the spine in its current position to prevent it worsening and there is good evidence that it works. The alternative is a “night-time brace”, which is only worn in bed at night. Night-time braces push the curve to make it straighter overnight, though the evidence for its benefit is less clear. Adolescents do not like wearing braces, as they interfere with activities and are uncomfortable, so there are advantages to wearing a brace just at night. This study will investigate if a night-time brace is as good as the full-time brace and will find out patient’s experiences of the two braces._x000D_ _x000D_ Methods_x000D_ We will ask children with scoliosis who have not previously received bracing to take part in this study. For those who agree, a computer will randomly decide which brace the child uses. At each check-up their doctor or nurse will find out how the child is doing and will x-ray their back. The child will remain in brace until they have finished growing or need to have surgery. The child will complete questionnaires at each hospital appointment (usually every 6 months). At the end of growth, after the bracing is stopped, there will then be two further clinic visits at one and two years for further x-rays and questionnaires. The main question is to look at the number of patients wearing each brace whose curve progresses to a size where surgery is considered._x000D_ We will interview some families within the first 6 months of wearing the brace to understand their experiences of bracing – they will be asked about how they have found sleeping in the brace, pain, and their general experience of wearing their brace. The cost of scoliosis treatment will be collected to understand the cost to the NHS._x000D_ _x000D_ Patient and public involvement_x000D_ Two patient groups and an on-line survey of Scoliosis Association UK (SAUK) members have reviewed the study and feel this is a relevant and important question. Patients who experienced full-time bracing commented on its negative effects (pain, appearance, bullying and interference with sleep and physical activity). The groups have inputted into the design of the study, particularly the method of completion and number of questionnaires. We will work closely with the group during the study in order to design study materials and ensure the study is acceptable to young people and their families. A child who has scoliosis, a SAUK regional representative and a parent of a child with scoliosis will work closely with the trial to coordinate and run the trial._x000D_ _x000D_ Dissemination_x000D_ Results of the study will be distributed to patients, parents and clinicians via SAUK, patient forums (including Mumsnet, Twitter, Facebook) and academic conferences and publications.

Lay abstract: 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?_x000D_ _x000D_ 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. _x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL