Multiple MyelomaMAPPNCT02898064
Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace
A study testing thoracolumbosacral orthosis or cervicothoracolumbar orthosis in people with Multiple Myeloma, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- thoracolumbosacral orthosis or cervicothoracolumbar orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2016to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with MM
- Myeloma infiltration in the spine confirmed by radiological evidence
- MM-related back pain
- Can attend for the whole follow up period
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- thoracolumbosacral orthosis or cervicothoracolumbar orthosis, Standard care
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracolumbosacral orthosis or cervicothoracolumbar orthosisDevice
Also called spinal brace
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.
Standard careOther
Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care
| Study group | Role | What they receive |
|---|---|---|
| Standard care + brace | Other | 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 Receives: Device: thoracolumbosacral orthosis or cervicothoracolumbar orthosis; Other: Standard care |
| Standard care | Other | Participant will receive standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from diagnosis to brace fitting for patients randomised to the intervention group
Measured: 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.
Measured: assessed at the end of study at 21 months
The number of orthotists in each hospital
Measured: 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.
Measured: 6 weeks
Number of appointments issued by orthotists
Measured: 21 months
Frequency of appointments issued by orthotists
Measured: 21 months
Secondary outcomes (10)
The number of new MM cases at each centre
Measured: 1 year
The number of eligible patients who give consent to enter the study
Measured: 21 months
The number of patients that drop-out during follow-up and their reasons
Measured: 21 months
The number of missing cases for a subsequent RCTs co-primary outcomes of pain and disability
Measured: 21 months
Pain measured by VAS
Measured: 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.
Measured: 3 months
Qualitative assessment of semi structured interviews in a sub-set of participants, EQ-5D-5L
Measured: 21 months
The number of patients who receive non-study-related interventions during the 3 month follow-up period
Measured: 3 months
Disability measured by ODI
Measured: 6 weeks and 3 months
Number of patients eligible for the study during 1 recruitment year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start19 Dec 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Konduru, Study director, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898064
- Sponsor's protocol ID
- 1017
- Acronym
- MAPP
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only anonymised patient data would be published
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02898064
- Acronym / sponsor ID
- MAPP / 1017
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care + brace | Other | Device: thoracolumbosacral orthosis or cervicothoracolumbar orthosis, Other: Standard careSpinal 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 |
| Standard care | Other | Other: Standard careParticipant will receive standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with MM
- Myeloma infiltration in the spine confirmed by radiological evidence
- MM-related back pain
- Can attend for the whole follow up period
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracolumbosacral orthosis or cervicothoracolumbar orthosisAlso: spinal braceAn "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. | Device | Standard care + brace |
| Standard careStandard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care | Other | Standard care, Standard care + brace |
Primary outcome
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
Time frame: 6 weeks
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.
Number of appointments issued by orthotists
Time frame: 21 months
Frequency of appointments issued by orthotists
Time frame: 21 months
10 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No. Only anonymised patient data would be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Konduru study director
University Hospitals of North Midlands NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracolumbosacral orthosis or cervicothoracolumbar orthosis in people with Multiple Myeloma, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from diagnosis to brace fitting for patients randomised to the intervention group (time frame: Assessed at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.