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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rehabilitation Institute of Chicago; Shirley Ryan AbilityLab
• Collaborator: Mallinckrodt
• Treatments: Hydromorphone

Criteria

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.