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
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.
- Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease
or anatomic abnormalities,
- Applicants may have pain radiating to their legs.
- Any episode of Acute LBP within the last 6 weeks or less
- Recent Fractures, less than 8 weeks of any bone
- Tumors of any type including soft tissue tumors, myeloma, malignant or documented
tumors of any type
- Gross osteoporosis,
- Spondylolisthesis grade 2 and above,
- Hardware fixation, spine fixation or other boney fusion
- Obesity as defined by a BMI greater than 35, body weight over 287 pounds,
- Contra-indication for MRJ assessment,
- neurologic deficits,
- bowel or bladder incontinence,
- progressive lower extremity weakness,
- need for narcotic pain medications for other conditions.