The Comparative Study for Treatment Outcomes of Osteoporotic Compression Fracture Without Neurologic Injury Using Rigid Brace, Soft Brace, and no Brace
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Compression Fracture
- Sponsor
- Seoul National University Hospital
- Enrollment
- 60
- Primary Endpoint
- Oswestry Disability Index (ODI) at 12 Weeks
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jin S. Yeom
professor
Seoul National University Hospital
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.
Outcomes
Primary Outcomes
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 Outcomes
- General Health Status(at the initial enrollment and 12 weeks after compression fracture)
- Oswestry Disability Index (ODI)(at 2 weeks, 6 weeks, and 12 weeks after compression fracture.)
- the Progression of Body Compression Ratio Over All Follow-up Assessments(2 weeks, 6 weeks, and 12 weeks after compression fracture)
- Visual Analog Pain Scale (VAS) for Back Pain(2 weeks, 6 weeks, 12 weeks after injury)