An interventional study of thoracolumbosacral orthosis or cervicothoracolumbar orthosis and Standard care in Multiple Myeloma, sponsored by University Hospitals of North Midlands NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by University Hospitals of North Midlands NHS Trust · Not applicable, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 2 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →University Hospitals of North Midlands NHS Trust is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Not suitable for treatment with a brace e.g. pregnancy
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
Device: thoracolumbosacral orthosis or cervicothoracolumbar orthosis · Other: Standard care
Participant will receive standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates
Other: Standard care
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.
Also known as: spinal brace
Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care
Time from diagnosis to brace fitting for patients randomised to the intervention group
Time frame: Assessed at 3 months
Number of patients in the intervention arm who request additional support from the orthotic team and time they had to wait for support.
Time frame: assessed at the end of study at 21 months
The number of orthotists in each hospital
Time frame: 21 months
Are appropriate braces fitted
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.
Time frame: 6 weeks
Number of appointments issued by orthotists
Time frame: 21 months
Frequency of appointments issued by orthotists
Time frame: 21 months
The number of new MM cases at each centre
Time frame: 1 year
The number of eligible patients who give consent to enter the study
Time frame: 21 months
The number of patients that drop-out during follow-up and their reasons
Time frame: 21 months
The number of missing cases for a subsequent RCTs co-primary outcomes of pain and disability
Time frame: 21 months
Pain measured by VAS
Time frame: 6 weeks and 3 months
Descriptive statistics and qualitative analysis of the 3-month follow up patient questionnaire
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.
Time frame: 3 months
Qualitative assessment of semi structured interviews in a sub-set of participants, EQ-5D-5L
Time frame: 21 months
The number of patients who receive non-study-related interventions during the 3 month follow-up period
Time frame: 3 months
Disability measured by ODI
Time frame: 6 weeks and 3 months
Number of patients eligible for the study during 1 recruitment year.
Time frame: 1 year
Plan to share: No — Only anonymised patient data would be published
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University Hospitals of North Midlands NHS Trust