Back pain prevention in multiple myeloma using a spinal brace (MAPP)
Research type
Research Study
Full title
Back pain prevention in multiple myeloma using an external spinal brace - a feasibility study
IRAS ID
193475
Contact name
Sandeep Konduru
Contact email
Sponsor organisation
University Hospitals of North Midlands NHS Trust
ISRCTN Number
ISRCTN11368725
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Myeloma is a blood cancer that affects several bones, mostly the spine. Around one person in 120-150 is at risk of developing myeloma. Current treatment can control the cancer and symptoms. However, it does not offer a cure and has little effect on preventing back pain, disability, spinal deformity - which may need difficult spinal surgery. \n\nAn audit of our own practice suggests using an external spinal brace during treatment can: \n•\treduce back pain intensity \n•\thelp prevent disability \n•\tminimise the risk of spinal deformity\n•\treduce NHS costs\n\nManaging such back pain with a brace has not been tested and is not routine practice in other centres in the UK. Therefore, this feasibility study will determine if a randomised controlled trial (RCT) of the brace in multiple centres is possible. We will use the information from this feasibility study to plan a subsequent RCT. The RCT will assess whether using a brace can minimise back pain and disability compared to standard medical treatment alone. \n\nIn this feasibility study, 80 consenting myeloma patients will be randomly allocated to receive either standard medical treatment (chemotherapy, radiotherapy, pain killing medication) alone or a brace with standard medical treatment. Patients will be evaluated at baseline, 6 weeks and 3 months to determine the number of patients required for the full trial. Information will be collected to inform a list of requirements a centre needs to have in place to perform an RCT.\n\nPatient and public involvement (PPI) has shaped the design of this study, including suggesting disability as an outcome.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0166
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion