Consenting patients with multiple myeloma (MM) will be randomly allocated to receive
either standard medical treatment (chemotherapy, radiotherapy, pain-killing medication)
alone or standard medical treatment plus a brace. Patients will be regularly evaluated in
research clinics; the results data will inform the design of a full trial. Information
will be collected to inform a list of requirements a centre needs to have in place to run
an RCT of these interventions.

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

Multiple Myeloma

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 left with disabling back pain, sometimes requiring surgical
intervention. University Hospitals of North Midlands NHS Trust 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 appears to maintain the overall alignment of the spine, thus
minimising risk of spinal deformity and consequent back pain.

The ultimate aim is to undertake an RCT to determine whether the use of an external
spinal brace can reduce back pain and spine-related disability in patients suffering from
back pain due to multiple myeloma, in comparison to conventional management without a
brace.

However, prior to this, a feasibility study is required. The feasibility study is needed
to see if the trial processes (providing patient information, consent process, conducting
the baseline investigations and outcome measures) can be accommodated without causing too
much delay to the application of the brace.

Suitable patients will be consented by the research team and randomised to receive a
brace or no brace in addition to their routine Myeloma treatment. After baseline data
collection and questionnaires, the participant would be followed up for data collection
at 6 weeks and 3 months.

thoracolumbosacral orthosis or cervicothoracolumbar orthosis

Standard care

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study

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.

The questionnaire consists principally of ordinal rating scales, which will be analysed
descriptively in terms of frequencies, medians and interquartile ranges. Qualitative data
from the supplementary open-ended questions will be analysed by means of framework
analysis.

Spinal brace (thoracolumbosacral orthosis or cervico-thoraco-lumbar orthosis) to be
fitted to the participant in addition to receiving standard of care treatment which can
include radiotherapy, chemotherapy or surgery including vertebral augmentation and also
medication including bisphosphonates

Participant will receive standard of care treatment which can include radiotherapy,
chemotherapy or surgery including vertebral augmentation and also medication including
bisphosphonates

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status