BACBONE: Bracing for spinal bone disease in newly diagnosed myeloma: A phase III randomised controlled trial

Research question: Does short-term external spinal bracing reduce long term disability in patients with newly diagnosed multiple myeloma (MM) with painful spinal disease? Background: There are ~6000 cases of MM a year in UK, median age 71 years. This incurable cancer of plasma cells causes painful bone destruction in most patients. When the disease is active the bones are fragile and liable to fracture, most commonly in the spine causing vertebral compression fractures leading to kyphosis. 38% of patients have back pain at diagnosis due to spinal involvement. As MM treatment starts patients may paradoxically experience further fractures, due to loss of supporting tumour mass, worsening the kyphosis and pain. As disease control is established, partial bone healing occurs, but this leads to irreversible fixation of the spinal deformity, resulting in long-term disability. MM is highly treatable with long remissions and median overall survival over 5 years Making Quality of life (QoL) of paramount importance. A few UK hospitals have started employing spinal bracing soon after diagnosis, aiming to redress the destructive spinal process but no robust evidence supports this practice and standard of care in the UK remains not to brace. Aims and Objectives: To assess whether rigid spinal bracing for 12 weeks after diagnosis of myeloma can reduce disability, pain, spinal deformity and modify other key patient factors. Methods: Phase III, Multicentre, randomised controlled trial with centralised spinal multidisciplinary team (MDT) eligibility review, national orthotics delivery and embedded internal pilot and cost-effectiveness evaluation. 260 patients with newly diagnosed MM and painful spinal disease will be randomised 1:1 at 34 UK sites to the wearing of a rigid custom-made plastic brace during the daytime for 12 weeks + education versus education alone. A central rapidly responsive MDT of spinal surgeons and radiologists will provide specialist eligibility review. A 2-stage consent process aims to engage patients widely in the UK including from ethnically diverse and socioeconomically deprived areas. Orthoses will be provided through 3 experienced national suppliers providing training to sites. The primary outcome will be reduction in disability by the Oswestry disability index =8 points at 12 months. Key secondary outcomes include pain, measures of spinal deformity, and quality of life. An internal pilot will assess site set up, recruitment, orthosis delivery and acceptability with review at 12 months. A study within a project (SWAP) will provide qualitative information about the challenges patients experience living with myeloma spine and with bracing. Patients have helped develop the trial and will be central throughout. Timelines: Trial duration 60m. Study setup 12m, recruitment 24m (including 12m internal pilot), 12m follow up, and 12m analyses and dissemination. Anticipated impact and dissemination: Trial results will enable definitive evaluation of the role of spinal bracing in MM with the goal of improving QoL. The trial will collect health-economic and logistic information to support commissioning and national implementation if the intervention is effective, and cost savings and service streamlining if not. Findings will be presented at international and national meetings, via patient organisations and social media to clinicians and patients. Publications will be in peer-reviewed scientific journals and patient literature.