Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
Status unconfirmed · Not applicable
Conditions studied: Chronic Lower Back Pain, Chronic Opioid Use
In brief
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 therapies have not been well studied although preliminary evidence shows the utilization of bracing may be beneficial in reducing pain and medication usage. * Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic lumbar brace may decrease opioid use in chronic low back pain patients on a stable opioid regimen. The investigators propose to conduct a randomized controlled study to test our hypothesis. * Specific Objectives. AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace, elastic abdominal binder (standard care), and no brace (control). AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life, and functional capacity. Long Term aims: To decrease patient's chronic pain level, improve overall daily function, decrease overall opioid intake and improve quality of life.
Key facts
- Study ID
- NCT02241824
- Run by
- Geoffrey C. Garth
- People needed
- 36
- Starts
- 2015-01-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2015-07-09
Who can join
Age: 20 and older, up to 72. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Long Beach VA — Long Beach, California, United States (enrolling)
Full record on ClinicalTrials.gov
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