True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Hydromorphone ER; Sugar pill
Intervention description: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.; Sugar pill
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low Back Pain; Back Pain; Chronic back pain

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.
    

Eligibility 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.