Status:
COMPLETED
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Mallinckrodt
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER)...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01455519
Start Date
October 1 2011
End Date
December 1 2014
Last Update
October 24 2017
Active Locations (1)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611