Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

Back pain is a common and expensive medical condition. Although rarely life-threatening, back
disorders are a major cause of pain, disability, and social cost affecting the quality of
life in most patients. Although primary care providers routinely treat back pain, little is
known about how often primary care providers manage occupation-related symptoms and how
outcomes compare with other treatment modalities. Treatment outcomes utilizing a
non-operative treatment paradigm have not been adequately studied. This paradigm consists of
treating patients sequentially with analgesics, physical therapy, use of back supports,
caudal epidural steroid injections, or surgical referral. The use of spinal supports as a
complimentary treatment along with physical therapy and posture education is promising.

Inclusion Criteria:

- Patients must present with clinical symptoms of low back pain and evaluated by the
study physician

- Visual Analog Score (VAS) for Pain >6 in response to the following question: Circle
one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain
you experienced in last week."

- Patients must have x-ray and or an MRI film for diagnostic evaluation based on
physician judgment.

- Age >18; both male and female

- Pain duration >3 months

Exclusion Criteria:

- Prior use of opioids, physical therapy, epidural injections for back pain or ongoing
chiropractor care and or acupuncture treatment

- Moderate to severe arthritis of the spine/ knee or hip that might severely compromise
ambulation and or posture

- Patients with diagnosed lumbar canal stenosis

- Serious concomitant medical illness (i.e., heart disease)

- Obese patients (twice the width of the Moller Orthopedic Back Support)

- Patients with moderate to severe scoliosis

- Past or present existence of a movement disorder, e.g., Parkinsonism, or any
neurological disease that might affect ambulation and or postural changes History of
osteoporosis

- Severe psychiatric disorder

- Prior spine surgery

- Multiple vertebral compression fractures with kyphosis

- Past or present workmen's compensation claim, SSI disability, or ongoing litigation