Clinical trial NCT02898064: Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace
Official title: Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from diagnosis to brace fitting for patients randomised to the intervention group
timeFrame: Assessed at 3 months
measure: Number of patients in the intervention arm who request additional support from the orthotic team and time they had to wait for support.
timeFrame: assessed at the end of study at 21 months
measure: The number of orthotists in each hospital
timeFrame: 21 months
measure: Are appropriate braces fitted
timeFrame: 6 weeks
measure: Number of appointments issued by orthotists
timeFrame: 21 months
measure: Frequency of appointments issued by orthotists
timeFrame: 21 months
Secondary outcomes:
measure: The number of new MM cases at each centre
timeFrame: 1 year
measure: The number of eligible patients who give consent to enter the study
timeFrame: 21 months
measure: The number of patients that drop-out during follow-up and their reasons
timeFrame: 21 months
measure: The number of missing cases for a subsequent RCTs co-primary outcomes of pain and disability
timeFrame: 21 months
measure: Pain measured by VAS
timeFrame: 6 weeks and 3 months
measure: Descriptive statistics and qualitative analysis of the 3-month follow up patient questionnaire
timeFrame: 3 months
measure: Qualitative assessment of semi structured interviews in a sub-set of participants, EQ-5D-5L
timeFrame: 21 months
measure: The number of patients who receive non-study-related interventions during the 3 month follow-up period
timeFrame: 3 months
measure: Disability measured by ODI
timeFrame: 6 weeks and 3 months
measure: Number of patients eligible for the study during 1 recruitment year.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
affiliation: University Hospitals of North Midlands NHS Trust
name: Sandeep Konduru
role: STUDY_DIRECTOR
References: