Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain (LSO LBP)
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|ClinicalTrials.gov Identifier: NCT01933399|
Recruitment Status : Completed
First Posted : September 2, 2013
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: Inextensible LSO (stiff back support) Other: Extensible LSO, a back support that is flexible Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Standard of Care
Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Other: Standard of Care
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
Experimental: Extensible lumbosacral orthoses plus standard of care
This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter
Other: Extensible LSO, a back support that is flexible
Back support is constructed from lycra and neoprene with velcro fasteners.
Experimental: Inextensible lumbosacral orthoses and standard of care
This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Other: Inextensible LSO (stiff back support)
Cotton/nylon canvas back support with velcro fasteners.
- Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) [ Time Frame: Baseline and 2 weeks ]Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.
- Change Score in the Patient Specific Activity Scale [ Time Frame: Baseline and 2-weeks ]Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933399
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||David Morrisette, PT, PhD||Medical Unversity of South Carolina|