Plain English Summary
Background and study aims
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 external spinal brace during treatment may be able to reduce back pain intensity, help prevent disability, minimise the risk of spinal deformity, and reduce the 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, the aim of this study is to find out whether it is possible to run a full study of the brace in multiple centres, which would assess whether using a brace minimises back pain and disability compared to standard medical treatment alone.
Who can participate?
Patients aged over 18 with myeloma-related back pain
What does the study involve?
Participants are randomly allocated to receive either standard medical treatment (chemotherapy, pain-killing medication) alone or a brace with standard medical treatment. Participants are regularly assessed at research clinics to determine the number of patients required for the full study. Information is collected to inform a list of requirements a centre needs to have in place to run the full study. The total duration of treatment and follow up is 3 months, and a subset of 20 participants is asked to complete a questionnaire at the end of the 3-month period.
What are the possible benefits and risks of participating?
Patients with MM are surviving longer, but are often left with a disability due to chronic back pain. The full study will determine whether using 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 study will find out whether the full study is possible and, if so, inform its design.
Where is the study run from?
1. University Hospitals of North Midlands NHS Trust (UK)
2. Royal Wolverhampton NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2016 to May 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Sandeep Konduru
Trial website
Contact information
Type
Public
Primary contact
Mr Sandeep Konduru
ORCID ID
http://orcid.org/0000-0001-6884-5737
Contact details
University Hospitals of North Midlands NHS Trust
Royal Stoke University Hospital
Newcastle Road
Stoke on Trent
ST4 6QG
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02898064
Protocol/serial number
1017
Study information
Scientific title
Back pain prevention in multiple myeloma using an external spinal brace (MAPP) - a feasibility study
Acronym
MAPP
Study hypothesis
Is it feasible to use an external spinal brace to decrease back pain and spine related disability in patients suffering from back pain due to multiple myeloma?
Ethics approval
East Midlands - Leicester South Research Ethics Committee, 27/05/2016, ref: 16/EM/0166
Study design
Randomised controlled multi-centre feasibility trial with two parallel groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Back pain in multiple myeloma
Intervention
Participants will be randomly assigned to either control or intervention groups with 1:1 allocation via a computerised random number generator using permuted blocks of random sizes. The randomisation procedure will be conducted by an independent statistician at Keele University and will be stratified by site; block sizes will not be disclosed to ensure concealment. Sealed opaque envelopes containing group allocations will be available at each centre. These will be opened by the research nurse following collection of baseline measurements.
Patients will be randomly allocated to receive either standard medical treatment alone or standard medical treatment plus an external back brace. (Standard medical treatment consists of chemotherapy, radiotherapy, pain killing medication). 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. Total duration of treatment and follow up will be three months for all treatment arms with a subset of 20 participants being asked to take part in a qualitative questionnaire at the end of the 3-month period.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Time from diagnosis to brace fitting for patients randomised to the intervention group. Dates to be collected by the research team - aim to complete trial recruitment process, i.e. consent to fitting of back brace, within 4 weeks
2. Number of patients in the intervention arm who request additional support from the orthotic team and time they had to wait for support. Dates and information collected by the research team throughout the study at 6 weeks and 3 months
3. The number of orthotists in each hospital and the number and frequency of appointments issued by them. Data collected by the research sites throughout the study
4. The locations and levels of VCFs and back pain in patients and the type of brace fitted will be recorded to determine whether appropriate braces are fitted. Radiological evidence collected (x-ray and MRI) at 6 week and 3 month follow up
Secondary outcome measures
1. The number of new MM cases at each centre and the number eligible for the study during 1 recruitment year, measured at screening
2. The number of eligible patients who give consent to enter the study, measured at screening
3. The number of patients that drop-out during follow-up and their reasons, measured throughout the study until end of recruitment
4. Co-primary outcomes of pain measured by VAS and disability measured by ODI, EQ-5D-5L, measured at 6 week and 3 month follow up
5. Quality of life and pain, measured with a patient questionnaire at 3 month follow up
6. Patient acceptability, measured using semi-structured interviews in a subset of participants at 3 month follow up
7. The number of patients who receive non-study-related interventions during the 3 month follow-up period, measured at 6 week and 3 month follow up
Overall trial start date
01/06/2016
Overall trial end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults with MM
2. Myeloma infiltration in the spine confirmed by radiological evidence
3. MM-related back pain
4. Can attend for the whole follow-up period
5. Aged >18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Presenting with cord compression and neurological deficit requiring urgent decompression and intervention
2. Chronic pain syndrome
3. Language barrier that cannot be overcome using translation services
4. Unwilling or unable to give informed consent
5. Painful vertebral compression fractures (VCFs) at the lumbosacral junction (L4 to Sacrum) where application of brace is not possible
6. Not suitable for treatment with a brace e.g. pregnancy
Recruitment start date
03/01/2017
Recruitment end date
28/02/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of North Midlands NHS Trust
ST4 6QG
Trial participating centre
Royal Wolverhampton NHS Trust
WV19 0QP
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study findings will be submitted for publication in haematology and orthopaedic journals as well as general medical journals. The team will approach the organisers of a myeloma patient education day at Myeloma UK and request they become keynote speakers on the potential for use of spinal bracing for reducing back pain for multiple myeloma patients and also to discuss the proposed subsequent full RCT. Such events are frequently attended by nurses, allied health professionals and service managers directly involved in the clinical pathways for myeloma patients.
The patient representatives are ideally placed to disseminate findings of the research with members of Myeloma UK and will be actively involved in designing the presentations and material to be used for this purpose. The results will also be presented at the British Society for Haematology conference the site requirements needed to partake in the full RCT will be discussed. This may enable the trialists to identify suitable partner sites to take part in such a study.
IPD sharing statement
The datasets generated and/or analysed during the current study will be included in the subsequent results publication.
Intention to publish date
31/05/2019
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN11368725_PIS_26Aug16.docx Uploaded 05/07/2017