Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

NCT02898064 | Completed

• 1 other identifier: 1017
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

• Time from diagnosis to brace fitting for patients randomised to the intervention group

  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.

  assessed at the end of study at 21 months

• The number of orthotists in each hospital

  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.

  6 weeks

• Number of appointments issued by orthotists

  21 months

• Frequency of appointments issued by orthotists

  21 months

Secondary Outcomes (10)

• The number of new MM cases at each centre

  1 year

• The number of eligible patients who give consent to enter the study

  21 months

• The number of patients that drop-out during follow-up and their reasons

  21 months

• The number of missing cases for a subsequent RCTs co-primary outcomes of pain and disability

  21 months

• Pain measured by VAS

  6 weeks and 3 months

Study Arms (2)

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

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

Other: Standard care

Interventions

thoracolumbosacral orthosis or cervicothoracolumbar orthosis 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.

Also known as: spinal brace

Standard care + brace

Standard care OTHER

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

Standard care; Standard care + brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with MM
• Myeloma infiltration in the spine confirmed by radiological evidence
• MM-related back pain
• Can attend for the whole follow up period

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sandeep Konduru

  University Hospitals of North Midlands NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: September 13, 2016
• Study Start: December 19, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)