Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

NCT ID: NCT02898064

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-19
• Study Completion Date: 2018-05-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care + brace

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

Group Type: OTHER

thoracolumbosacral orthosis or cervicothoracolumbar orthosis

Intervention Type: DEVICE

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 care

Intervention Type: OTHER

Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care

Standard care

Participant will receive standard of care treatment which can include radiotherapy, chemotherapy or surgery including vertebral augmentation and also medication including bisphosphonates

Group Type: OTHER

Standard care

Intervention Type: OTHER

Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care

Interventions

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.

Intervention Type: DEVICE

Standard care

Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care

Intervention Type: OTHER

Other Intervention Names

spinal brace

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandeep Konduru

Role: STUDY_DIRECTOR

University Hospitals of North Midlands NHS Trust

Locations

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

1017

Identifier Type: -

Identifier Source: org_study_id