N/A N=60 Randomized Single-blind Treatment

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

Compression Fracture

Bottom Line

View on ClinicalTrials.gov: NCT02049931 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

May 2015

Primary outcome: Primary: Oswestry Disability Index (ODI) at 12 Weeks — 35.95; 33.54; 37.83 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: No brace treatment (Device); Rigid brace (Device); Soft brace (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Oct 2013

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	—

Summary

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

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.

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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.