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Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

Primary Purpose

Compression Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No brace treatment
Rigid brace
Soft brace
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Compression Fracture focused on measuring osteoporosis, compression fracture, brace

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height,
  • compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit.

Exclusion Criteria:

  • the presence of more than two recent vertebral fractures,
  • pathologic malignant compression fractures,
  • neurologic complications,
  • a history of previous injury or surgery to the fractured level,
  • inability to complete the questionnaires about pain and disability.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    No brace group

    Rigid brace group

    Soft brace group

    Arm Description

    Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.

    Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.

    Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.

    Outcomes

    Primary Outcome Measures

    Oswestry Disability Index (ODI) at 12 Weeks
    The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).

    Secondary Outcome Measures

    Visual Analog Pain Scale (VAS) for Back Pain
    The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
    Oswestry Disability Index (ODI)
    The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
    General Health Status
    The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    the Progression of Body Compression Ratio Over All Follow-up Assessments
    The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level

    Full Information

    First Posted
    January 28, 2014
    Last Updated
    August 5, 2018
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02049931
    Brief Title
    Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
    Official Title
    The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
    Detailed Description
    Bracing has been considered as a landmark step in conservative management for osteoporotic compression fractures. However, no prospective, randomized, and controlled clinical trials are available to document for the efficacy of wearing of the rigid or soft brace for the management of osteoporotic compression fracture. Therefore, the current trial was therefore designed to compare the outcome for improvement of disability and pain in patients with osteoporotic compression fracture using rigid, soft, or no brace.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Compression Fracture
    Keywords
    osteoporosis, compression fracture, brace

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No brace group
    Arm Type
    Experimental
    Arm Description
    Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
    Arm Title
    Rigid brace group
    Arm Type
    Active Comparator
    Arm Description
    Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
    Arm Title
    Soft brace group
    Arm Type
    Active Comparator
    Arm Description
    Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    No brace treatment
    Intervention Description
    Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
    Intervention Type
    Device
    Intervention Name(s)
    Rigid brace
    Intervention Description
    In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Soft brace
    Intervention Description
    In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
    Primary Outcome Measure Information:
    Title
    Oswestry Disability Index (ODI) at 12 Weeks
    Description
    The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
    Time Frame
    12 weeks after injury
    Secondary Outcome Measure Information:
    Title
    Visual Analog Pain Scale (VAS) for Back Pain
    Description
    The VAS for back pain comprised a 10-cm line with "none" (0) on one end and "disabled pain" (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.
    Time Frame
    2 weeks, 6 weeks, 12 weeks after injury
    Title
    Oswestry Disability Index (ODI)
    Description
    The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).
    Time Frame
    at 2 weeks, 6 weeks, and 12 weeks after compression fracture.
    Title
    General Health Status
    Description
    The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    Time Frame
    at the initial enrollment and 12 weeks after compression fracture
    Title
    the Progression of Body Compression Ratio Over All Follow-up Assessments
    Description
    The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level
    Time Frame
    2 weeks, 6 weeks, and 12 weeks after compression fracture

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the presence of acute back pain caused by a single level vertebral fracture within 3 days of minor trauma such as fall from height, compression fracture between T 7 and L3 including injuries of only anterior compartment of vertebral body without neurologic deficit. Exclusion Criteria: the presence of more than two recent vertebral fractures, pathologic malignant compression fractures, neurologic complications, a history of previous injury or surgery to the fractured level, inability to complete the questionnaires about pain and disability.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ho-Joong Kim, MD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25471910
    Citation
    Kim HJ, Yi JM, Cho HG, Chang BS, Lee CK, Kim JH, Yeom JS. Comparative study of the treatment outcomes of osteoporotic compression fractures without neurologic injury using a rigid brace, a soft brace, and no brace: a prospective randomized controlled non-inferiority trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1959-66. doi: 10.2106/JBJS.N.00187.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

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