Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain (LSO LBP)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01933399

16527

Details and patient eligibility

About

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).

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 3 patient groups

Standard of Care

Other group

Description:

Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.

Treatment:

Other: Standard of Care

Extensible lumbosacral orthoses plus standard of care

Experimental group

Description:

This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter

Treatment:

Other: Extensible LSO, a back support that is flexible

Inextensible lumbosacral orthoses and standard of care

Experimental group

Description:

This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.

Treatment:

Other: Inextensible LSO (stiff back support)