CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 98 enrolled
Drug / intervention
Inextensible LSO (stiff back support) +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01933399
NCT01933399N/ACompleted

Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain

Medical University of South Carolina·interventional·Posted Sep 2, 2013·Updated Apr 30, 2015

In Brief

A clinical study evaluating Inextensible LSO (stiff back support), Extensible LSO, a back support that is flexible, and 1 other intervention for Low Back Pain. Completed, enrolled 98 participants across 1 site.

Detailed Summary

This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2, 2013
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 12.8 years ago

Interventions

Inextensible LSO (stiff back support)other

Cotton/nylon canvas back support with velcro fasteners.

Extensible LSO, a back support that is flexibleother

Back support is constructed from lycra and neoprene with velcro fasteners.

Standard of Careother

Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.