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Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

NCT02898064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-07-05

No results posted yet for this study

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

Interventions

DEVICE

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.

OTHER

Standard care

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

Sponsors & Collaborators

  • University Hospitals of North Midlands NHS Trust

    lead OTHER

Principal Investigators

  • Sandeep Konduru · University Hospitals of North Midlands NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-19
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02898064 on ClinicalTrials.gov