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Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

NCT01933399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2015-04-30

Study results available
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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).

Conditions

  • Low Back Pain

Interventions

OTHER

Inextensible LSO (stiff back support)

Cotton/nylon canvas back support with velcro fasteners.

OTHER

Extensible LSO, a back support that is flexible

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

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • David Morrisette, PT, PhD · Medical Unversity of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01933399 on ClinicalTrials.gov