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Trial record 1 of 1 for:    NCT02049931
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Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace

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ClinicalTrials.gov Identifier: NCT02049931
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : May 25, 2015
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE January 30, 2014
Results First Submitted Date  ICMJE April 15, 2014
Results First Posted Date  ICMJE May 25, 2015
Last Update Posted Date August 7, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
Oswestry Disability Index (ODI) at 12 Weeks [ Time Frame: 12 weeks after injury ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
Improvement of Oswestry Disability Index (ODI) [ Time Frame: 12 weeks after injury ]
The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2018)
  • Visual Analog Pain Scale (VAS) for Back Pain [ Time Frame: 2 weeks, 6 weeks, 12 weeks after injury ]
    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) [ Time Frame: at 2 weeks, 6 weeks, and 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).
  • General Health Status [ Time Frame: at the initial enrollment and 12 weeks after compression fracture ]
    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 [ Time Frame: 2 weeks, 6 weeks, and 12 weeks after compression fracture ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
  • Visual Analog Pain Scale (VAS) for Back Pain [ Time Frame: 2 weeks, 6 weeks, 12 weeks after injury ]
    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) [ Time Frame: at 2 weeks, 6 weeks, and 12 weeks after compression fracture. ]
  • General Health Status [ Time Frame: at the initial enrollment and 12 weeks after compression fracture ]
    The general health status was assessed with use of the Short Form-36 (SF-36) at the initial enrollment and 12 weeks after compression fracture.
  • the Progression of Body Compression Ratio Over All Follow-up Assessments [ Time Frame: at the initial enrollment, 2 weeks, 6 weeks, and 12 weeks after compression fracture ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
Official Title  ICMJE The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Compression Fracture
Intervention  ICMJE
  • Device: No brace treatment
    Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
  • Device: Rigid brace
    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.
  • Device: Soft brace
    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.
Study Arms  ICMJE
  • Experimental: No brace group
    Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.
    Intervention: Device: No brace treatment
  • Active Comparator: Rigid brace group
    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.
    Intervention: Device: Rigid brace
  • Active Comparator: Soft brace group
    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: Device: Soft brace
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2014)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02049931
Other Study ID Numbers  ICMJE Brace001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin S. Yeom, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ho-Joong Kim, MD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP