N/A
Completed N=60
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
Compression Fracture
Source: ClinicalTrials.gov NCT02049931 ↗
Enrolled (actual)
60
Serious AEs
1.7%
Results posted
May 2015
Primary outcomePrimary: Oswestry Disability Index (ODI) at 12 Weeks — 35.95; 33.54; 37.83 units on a scale
Summary
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Disability Index (ODI) at 12 Weeks |
35.95; 33.54; 37.83 | — |
| SECONDARY Visual Analog Pain Scale (VAS) for Back Pain |
5.9; 5.5; 6.8; 4.6; 5.2; 6.3 | — |
| SECONDARY Oswestry Disability Index (ODI) |
56.84; 53.32; 64.19; 47.05; 52.53; 57.62 | — |
| SECONDARY General Health Status |
29.70; 34.18; 29.87; 31.15; 32.75; 33.53 | — |
| SECONDARY the Progression of Body Compression Ratio Over All Follow-up Assessments |
0.62; 0.67; 0.70; 0.58; 0.66; 0.65 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02049931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.