Multiple Myeloma Clinical Trial
Official title:
Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study
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.
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.
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