Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
Unknown statusNot applicableNCT02241824
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention
- Conditions
- Chronic Lower Back Pain
- Chronic Opioid Use
- Interventions
- Device: In-elastic lumbar brace
- Device: Elastic abdominal binder
- Sponsor
- Geoffrey C. Garth
- Collaborators
- VA Long Beach Healthcare System
- Organization
- Aspen Medical Products
- Start date
- 2015-01
- Primary completion
- 2016-09
- Sex
- Male
- Age range
- from 20 Years to 72 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02241824