Status:
UNKNOWN
Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
Lead Sponsor:
Geoffrey C. Garth
Collaborating Sponsors:
VA Long Beach Healthcare System
Conditions:
Chronic Lower Back Pain
Chronic Opioid Use
Eligibility:
MALE
20-72 years
Phase:
NA
Brief Summary
Rationale * Statement of the Problem. Low back pain is a significant societal problem in the United States, affecting approximately one-fourth of all Americans at any given time. Non-pharmacological ...
Detailed Description
Background and Significance Low back pain (LBP) is a common problem in our society with potential for significant morbidity and mortality. One of the treatments for LBP, opioid therapy, has been incr...
Eligibility Criteria
Inclusion
- Participants must satisfy diagnostic criteria for lumbar back pain
- Evidence of lumbar back pain base upon one or more of the following:
- Lumbar back pain episodes lasting greater than 3 months
- Has received treatment for recurring nonspecific low back pain
- Treatment with 3-6 months of stable opioid use.
- Men or women age greater than or equal to 20 years
- Fluency in English
Exclusion
- Treatment risk factors including one or more of the following:
- Unstable or symptomatic cardiac complaints
- Unstable or symptomatic respiratory complaints
- Unable to reliably comprehend the protocol or reliably record data
- Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
- No significant alcohol use (7 or fewer drinks per week).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02241824
Start Date
January 1 2015
End Date
December 1 2016
Last Update
July 9 2015
Active Locations (1)
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1
Long Beach VA
Long Beach, California, United States, 90822