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Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study (NCT02898064)

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.
  • Device: thoracolumbosacral orthosis or cervicothoracolumbar orthosis
    An "off the shelf spinal brace" which will be applied to the patients trunk. They will have straps and harnesses which the patient can fasten and remove if needed. The brace will need to be worn by the intervention group all the time for 3 months except when lying in bed. In the presence of lower thoracic (T8 downwards), thoraco-lumbar and lumbar (L1- L3) fractures, a thoracolumbosacral orthosis will be applied. For upper thoracic fractures (T1-T7) a cervico-thoracic or cervico-thoraco-lumbar orthosis will be used.
    • spinal brace
  • Other: Standard care
    Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Adults with MM
    • Myeloma infiltration in the spine confirmed by radiological evidence
    • MM-related back pain
    • Can attend for the whole follow up period
    Exclusion Criteria:
    • Presenting with cord compression and neurological deficit requiring urgent decompression and intervention
    • Chronic pain syndrome
    • Language barrier that cannot be overcome using translation services
    • Unwilling or unable to give informed consent
    • Painful VCFs at the lumbosacral junction, L4 to Sacrum, where application of brace is not possible. Not suitable for treatment with a brace e.g. pregnancy
    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.

    1 locations

    United Kingdom (1)
    • University Hospitals of North Midlands NHS Trust
      Not specified
      Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 August, 2016
    Updated:
    11 September, 2016
    Participants:
    80
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