Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

Not Applicable

Completed

Interventions: Other: Inextensible LSO (stiff back support)
Other: Standard of Care
Other: Extensible LSO, a back support that is flexible

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Inextensible lumbosacral orthoses and standard of care	Inextensible LSO (stiff back support)	This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.
Standard of Care	Standard of Care	Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.
Extensible lumbosacral orthoses plus standard of care	Extensible LSO, a back support that is flexible	This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter

Primary Outcome Measures

Name	Time	Method
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)	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.

Secondary Outcome Measures

Name	Time	Method
Change Score in the Patient Specific Activity Scale	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.