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Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention

NCT02241824 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-07-09

No results posted yet for this study

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 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.

Conditions

  • Chronic Lower Back Pain
  • Chronic Opioid Use

Interventions

DEVICE

In-elastic lumbar brace

DEVICE

Elastic abdominal binder

Sponsors & Collaborators

  • VA Long Beach Healthcare System

    collaborator FED

  • Geoffrey C. Garth

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
72 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02241824 on ClinicalTrials.gov