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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

Brief Summary:
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.

Condition or disease Intervention/treatment Phase
Compression Fracture Device: No brace treatment Device: Rigid brace Device: Soft brace Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
Study Start Date : December 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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.
Device: No brace treatment
Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02049931


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Ho-Joong Kim, MD Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin S. Yeom, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02049931    
Other Study ID Numbers: Brace001
First Posted: January 30, 2014    Key Record Dates
Results First Posted: May 25, 2015
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Jin S. Yeom, Seoul National University Hospital:
osteoporosis, compression fracture, brace
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Compression
Wounds and Injuries