Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention

Chronic Lower Back Pain Clinical Trial

Official title: Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 increasingly utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The long term use of opioids carries its own risk for adverse events and risk of addiction.3 Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid therapy, our attention needs to be drawn to find more affordable alternatives.

Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid use in the chronic low back pain population. The specific aims of this project are to perform a pilot study to assess the feasibility of this project and plan for a larger randomized controlled trial. Additional long-term goals of this study are to assess the effect of an inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in opioid use and subsequent control or reduction of pain. Secondary endpoints will note improvement in functional outcomes and other quality of life measures. The findings of this preliminary study conducted at the VA facility will provide data to perform a large multi-center randomized controlled trial and prepare for a NIH proposal to study other benefits of inelastic lumbar bracing.

(3) Work Accomplished

(a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions Following Pilot Studies: Sponsored new study

(4) Work Proposed This trial will be a prospective randomized three armed trial of an in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid medications with follow-up monitoring up to 12 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Lower Back Pain
• Chronic Opioid Use
• Low Back Pain

• NCT number: NCT02241824
• Study type: Interventional
• Source: Aspen Medical Products
• Contact: Eric Y Chang, MD
• Phone: (714) 598-1745
• Email: eric.chang6@va.gov
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Completion date: December 2016