ObServational sTudy Of myelOma Patients treated for spinal instability
Research type
Research Study
Full title
Exploration of symptom burden and functional consequences of spinal instability in myeloma patients treated with spinal bracing: an observational study
IRAS ID
308796
Contact name
Kwee Yong
Contact email
Sponsor organisation
University College London Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Z6364106/2022/02/99 heath research, UCL Data Protection Registration Number
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Background and Aims\nA study of 306 newly diagnosed myeloma patients reported 51% present with spinal disease, including 68% with compression fractures, and 15% with spinal cord compression (1). Skeletal-related events are associated with increased mortality, reduced quality of life (QoL) and place considerable burden on hospital resources. Therefore, the effective management of these patients is of increasing importance in order to improve clinical outcomes and QoL (2).\nThe guidelines report supervised physiotherapy can be advantageous for braced patients to prevent muscle wasting but there is little guidance about how and when this is delivered (3). \nThe ultimate aim is to undertake a randomized controlled trial (RCT) to determine if an exercise intervention is safe and can improve braced myeloma patients physical function and QoL in comparison to conventional treatment. To date there has been no research to look at this. \nHowever, prior to this an observational study needs to be completed to address the following aims.\n1)\tDescribe the functional capacity, symptoms and QoL of myeloma patients treated with spinal bracing for spinal instability \n2)\tQualitative and focus group interviews to explore their experience of wearing a brace and views on rehabilitation to inform the potential design of rehabilitation approaches.\n3)\tAssess the acceptability and feasibility of patient-centered outcome measures to inform use for future interventional study.\n\nMethod\nWe will recruit spinal braced patients at the University College London Hospital and undertake an observational cohort study. Data will be collected through QoL, disability, psychological questionnaires and physical tests at three timepoints. Initially at the time of their brace fitting, once the brace is removed and three months post brace removal. This data will be supplemented by focus group interviews to design an intervention that addresses the needs of spinal myeloma patients.
REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0089
Date of REC Opinion
25 Aug 2022
REC opinion
Further Information Favourable Opinion