Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain

ConditionsLow Back Pain Brace Emergencies Pain Health Care Resources

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Alberta

About this trial

Low back pain accounts for billions of dollars in health care expenditures. Most cases of back pain do not have a clear cause. Thus, low back pain management methods usually rely on targeting people' pain and discomfort. Painkillers, including opioids, are usually prescribed in the emergency departments for people with low back pain. But, like all medications, painkillers can have side effects, and some of those can be serious. There are also serious concerns about the overuse of painkillers. Thus, newer pain management methods are needed to reduce the use of painkillers in people with low back pain. Lumbar braces are one of the underutilized low back pain management methods in the emergency departments. Like crutches for leg and ankle injuries, they can minimise movements of the spine. This may decrease people pain and improve their function. This may also reduce the use of painkillers. In support of this approach, two recent studies conducted in a primary-care setting observed a reduction in the use of painkillers in people with low back pain who wore lumbar braces. The investigators are conducting this study to determine if wearing a lumbar brace for 4 weeks following emergency department presentation will reduce people's pain and discomfort and increase spine function. This may decrease the use of painkiller and future use of healthcare resources. This research study may also assist emergency-department staff with offering new recommendations to improve the quality of clinical decisions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 65 years

Ambulatory

Able to read and understand English

Living in Edmonton

Disqualifiers

Back pain due to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis

Pregnancy

Significant compression of the spinal cord/nerves

Previous back surgery

Trial design

Design model

Parallel

Treatments tested in this trial

Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618
Device
The brace is an FDA Class I, one-size adjustable design to fit waists ranging from 24-70 inches. Participants will be instructed to wear the brace for six weeks during the daytime

Treatment groups

152 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in the pain level

The change in the pain level between the baseline and 6-week follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".

Time frame

Week 6

Change in the pain level

The change in the pain level between the baseline and 4-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".

Time frame

Month 4

Change in the pain level

The change in the pain level between the baseline and 8-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".

Time frame

Month 8

Change in the pain level

The change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\]. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable".

Time frame

Month 12

Secondary outcomes

Change in the self-reported disability level - Questionnaire A

The change in the self-reported disability between the baseline and 6-week follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].

Time frame

Week 6

Change in the self-reported disability level - Questionnaire A

The change in the self-reported disability between the baseline and 4-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].

Time frame

Month 4

Change in the self-reported disability level - Questionnaire A

The change in the self-reported disability between the baseline and 8-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].

Time frame

Month 8

Change in the self-reported disability level - Questionnaire A

The change in the self-reported disability between the baseline and 12-month follow-up will be evaluated using the Oswestry Disability Index \[0-100 scale\].

Time frame

Month 12

Other outcomes

Change in healthcare resource utilization- regulated prescriptions filled (after enrollment)

The change in healthcare resource utilization, measured by counting the number of back-pain related regulated prescriptions filled from the baseline and the past 12 months after enrollment

Time frame

Month 12

Change in healthcare resource utilization- primary care visits (after enrollment)

The change in healthcare resource utilization, measured by counting the number of back-pain related primary care visits from the baseline and the past 12 months after enrollment

Time frame

Month 12

Change in healthcare resource utilization- specialist visits (after enrollment)

The change in healthcare resource utilization, measured by counting the number of back-pain related specialist visits from the baseline and the past 12 months after enrollment

Time frame

Month 12

Change in healthcare resource utilization- imaging (after enrollment)

The change in healthcare resource utilization, measured by counting the number of back-pain related imaging from the baseline and the past 12 months after enrollment

Time frame

Month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

American Orthotic and Prosthetic Association

Collaborator

Curtin University

Collaborator

Source ClinicalTrials.gov

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