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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: 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: 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.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: January 28, 2014
Date Started: December 2012
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015