Title: Back pain prevention in multiple myeloma using an external spinal brace - a feasiblity study
Funder: Department of Health and Social Care

Abstract: Background: Multiple myeloma (MM) is a neoplasia of plasma cells mostly within the bone marrow, commonly leading to multiple vertebral collapses. This causes spinal deformity, leading to incapacitating back pain and reduced quality of life. In spite of advances in medical therapy, some patients are still left with disabling back pain, sometimes requiring surgical intervention. We have observed on an audit of our own practice that application of an external spinal brace as early in the disease process as is possible can maintain the overall alignment of the spine, thus minimising risk of spinal deformity and consequent back pain. In the near future, we plan to conduct a randomised, controlled trial (RCT) in order to determine whether the external brace is truly effective in reducing back pain and disability. Since treatment with a brace in this group of patients is not standard practice in most centres in the UK and trial processes (such as confirming eligibility criteria using radiological evidence and obtaining patient consent) are likely to delay the application of the brace, we plan to conduct a feasibility study prior to conducting the full RCT. Aim: The aim of this feasibility study is to assess the practicality of conducting a multi-centre RCT and to collect information to inform the sample size calculation for the subsequent RCT. Objectives: Feasibility of conducting a multi-centre RCT, which will evaluate the ability of both sites to: Complete appropriate trial processes in a timely manner. Provide on-going support to patients using the brace. Information to inform the sample size of the subsequent RCT: includes calculating the number of eligible patients, patient recruitment and dropout rates, data retention rates and the standard deviation of the co-primary outcomes of pain and disability. Plan of investigation: Patients with MM who have new onset back pain will be invited to take part in this multi-centre feasibility study during their routine haematology clinic at University Hospital of North Midlands (UHNM), Stoke-on-Trent and Royal Wolverhampton NHS Trust. Eligible patients will be randomised to receive either a spinal brace in conjunction with standard care (chemotherapy and analgesia as needed), or standard care alone. The feasibility of the RCT (objective 1) will be tested by monitoring whether centres are able to complete all trial processes and fit the brace within 4 weeks of patient diagnosis. We will also record the number of requests for additional orthotic support and the time taken for this to be provided. A list of minimum logistical requirements will be created which will be used to identify other suitable centres for inclusion in the subsequent RCT. Objective 2 will be assessed by monitoring the number of current patients in both centres that are eligible for entry, then determining how many are willing to be recruited and then following up using the visual analogue scale and Oswestry Disability Index for the 3 month follow-up to determine dropout, missing information and the standard deviation of the outcomes. Potential benefit to patients: Patients with MM are surviving longer, but are often left with a disability due to chronic back pain. The full multi-centre trial will determine whether application of a simple low-cost brace can decrease back pain in these patients and improve their disability, thus potentially improving the quality of life of these patients and reducing the cost to the NHS. This feasibility study will find out whether the above definitive (multi-centre) RCT is possible and, if so, inform its design.

Lay abstract: 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. However, it does not offer a cure and has little effect on preventing back pain, disability, or spinal deformity - which may need difficult spinal surgery. An audit of our own practice suggests using an external spinal brace during treatment can: reduce back pain intensity help prevent disability minimise the risk of spinal deformity reduce need for surgery Managing back pain in myeloma 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. In this feasibility study, consenting myeloma patients from two centres will be randomly allocated to receive either standard medical treatment (chemotherapy, pain-killing medication) alone or a brace with standard medical treatment. Patients will be regularly evaluated in research clinics 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 run an RCT. Patient and public involvement (PPI) has shaped the design of this study, including suggesting disability as an outcome. In conjunction with a lay co-applicant, PPI during the study will: help develop interview guides and questionnaires consider patients acceptability of the brace advise on the need to measure other important patient outcomes in an RCT suggest effective ways to publish findings, including journals and public events

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL;CANCER AND NEOPLASMS