True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

As a participant in this study, you will be asked to come to the Rehabilitation Institute of
Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611).
Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation
Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

If you are in this study, you will be placed in one of two study groups: one group will
receive the study drug and one will receive a placebo. You will be assigned a study group by
chance using a process similar to the flip of a coin. This process is called randomization.
Neither you nor the study staff will select the group you will be in. A placebo looks like
the study drug but is an inactive substance that has no medication. Researchers use a placebo
to see if the study drug works better or is safer than not taking anything. You will have a
66% chance of getting the study drug. You will receive placebo at some point during the study
but you will not know whether you are receiving placebo or study drug during the entire
study. However, if you have a medical emergency, the investigators can get this information.

Inclusion Criteria:

- Meets our criteria for Chronic Non-Radicular Back Pain (CNRBP): non-radiating (below
buttocks), no frank weakness or atrophy, no sensory or reflex changes

- If female, is not pregnant or breast feeding, and not currently attempting to
conceive; if of childbearing potential, use of a highly effective method of birth
control (as determined by Pl).

- Able to read and speak English and provide informed consent; ages: 18-90.

- Able to understand and comply with all data collection methodology.

- Subjects may continue any non opioid, non acetaminophen stable drug regimen with no
changes during the course of study and not use rescue medications 12 hours before
testing.

- Subjects taking opioids must agree to detoxify for the protocol. If they agree they
will detox under the direction of the PI before entering the protocol. They may begin
the acetaminophen rescue med as per the protocol while in detox.

- Must have pain greater than or equal to 5 on a 10 point Numeric Rating scale (NRS) at
phone screening, or pain greater than or equal to 50 on VAS at visit one.

Exclusion Criteria:

- Subjects with hypersensitivity to Opioids, Acetominophen or Exalgo.

- Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression [esp
suicidality], anxiety, substance dependence).

- Subjects with a clinical diagnosis of fibromyalgia or polymyalgia rheumatica.

- Subjects with severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic
disease [creatinine>1.5 ml/dl; AST or ALT> 3x normal limit], uncontrolled
hypertension), pulmonary disease, uncontrolled seizure disorder, gastoparesis or
urinary retention.