Clinical Efficacy and Safety of Axiom Worldwide DRX9000 Axial Decompression System for Treatment of Low Back Pain

This study will document efficacy and safety of the Axiom Worldwide DRX9000™ for treatment
of low back pain (LBP) in a prospective, randomized, crossover, multicenter trial utilizing
a standardized clinical research multimodal protocol. During the first two weeks subjects
are randomized to receive either conservative care or DRX treatment first and then cross
over to receive either conservative care or DRX treatment the next 6 weeks. This study will
test the hypothesis that standardized 6-week treatment regimen of spinal decompression using
DRX9000™ will reduce chronic lower back pain more than conservative therapy (current
baseline therapy

Inclusion Criteria:

- In addition to a diagnosis of LBP, ALL of the following criteria must be met:

- Male or female, >18 years of age

- Able to provide written informed consent (ICF) to the IRB approved clinical
multimodal protocol

- Chronic (onset more than 12 weeks) low back pain with an intensity level of > 4
on a verbal rating scale for pain (VRS) of 0-10 (with 0 = no pain and 10 = worst
possible pain)

- Completed necessary diagnostic medical history evaluation forms as described in
the protocol to confirm the patient's diagnosis and eligibility for the study

- Willing and able to complete the 6 week 20 session DRX9000 outpatient treatments
and a minimum of 6 months follow-up

Exclusion Criteria:

- If ANY of the following exclusion criteria are present, the subject is NOT eligible:

- Pregnancy

- Evidence of neurologic motor deficits on clinical examination

- Evidence of spinal cord compression, metastatic cancer, tumor, hematoma,
infection or compression fracture

- Severe spinal stenosis

- Litigation for health-related claim (in process or pending), Worker's
Compensation, or Personal Injury cases

- Previous spine fusion surgery or instrumentation

- Hemiplegia or paraplegia

- Significant cardiovascular or metabolic disease, or abdominal aortic aneurysm

- Unwillingness to postpone other types of therapy for LBP that are not listed as
adjuncts in the research protocol

- Known alcohol abuse or drug abuse

- Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203
cm)

- Body weight greater than 300 pounds (136 kg)