Skip to main content
OpenTrials
Completed

NCT Number: NCT02898064

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands NHS Trust

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: spinal brace

Standard care

Other

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

Primary outcomes

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

    Time frame: Assessed at 3 months

  2. 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

  3. The number of orthotists in each hospital

    Time frame: 21 months

  4. 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.

  5. Number of appointments issued by orthotists

    Time frame: 21 months

  6. Frequency of appointments issued by orthotists

    Time frame: 21 months

Secondary outcomes

  1. The number of new MM cases at each centre

    Time frame: 1 year

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

    Time frame: 21 months

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

    Time frame: 21 months

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

    Time frame: 21 months

  5. Pain measured by VAS

    Time frame: 6 weeks and 3 months

  6. Descriptive statistics and qualitative analysis of the 3-month follow up patient questionnaire

    Time frame: 3 months

    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.

  7. Qualitative assessment of semi structured interviews in a sub-set of participants, EQ-5D-5L

    Time frame: 21 months

  8. The number of patients who receive non-study-related interventions during the 3 month follow-up period

    Time frame: 3 months

  9. Disability measured by ODI

    Time frame: 6 weeks and 3 months

  10. Number of patients eligible for the study during 1 recruitment year.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study

Acronym: MAPP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.