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Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.
Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.
The study will assess whether a computer-assisted traction treatment [decompression] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed
Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.
To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.
To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.
To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Low Back Pain
SpineMed Table, Cert HealthSciences LLC, SpineMed Table, Cert HealthSciences LLC
SUNY Upstate Medical University
Active, not recruiting
State University of New York - Upstate Medical University
Published on BioPortfolio: 2014-08-27T03:29:37-0400
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