Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain
Completed · Not applicable
Conditions studied: Low Back Pain
In brief
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).
Key facts
- Study ID
- NCT01933399
- Run by
- Medical University of South Carolina
- People needed
- 98
- Starts
- 2007-09-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- chief complaint of lower back pain, with or without lower extremity (LE) symptoms
- 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics
You may not qualify if…
- Exclusion criteria are:
- previous spinal surgery
- workman's compensation or litigation is involved
- neurological disease or injury
- systemic inflammatory disease
- pulmonary disease which restricts breathing capacity
- current pregnancy
- acute fracture
- tumor or metastatic disease
- infection
- neurological disease
- the presence of pathological reflexes (e.g., Babinski)
- the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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