ClinicalTrials.gov
ClinicalTrials.gov Menu

Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace (MAPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02898064
Recruitment Status : Not yet recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Device: thoracolumbosacral orthosis or cervicothoracolumbar orthosis Other: Standard care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace - a Feasibility Study
Study Start Date : September 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 Name: spinal brace

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898064


Contacts
Contact: Darren Clement 01782675379 darren.clement@uhnm.nhs.uk
Contact: Heather Reidy 01782675398 heather.reidy@uhnm.nh.uk

Locations
United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Investigators
Study Director: Sandeep Konduru University Hospitals of North Midlands NHS Trust

Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT02898064     History of Changes
Other Study ID Numbers: 1017
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only anonymised patient data would be published

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Back Pain
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms