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

NCT03829631 | Recruiting

• 1 other identifier: Pro00085904
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Brace; Emergencies; Pain; Health Care Resources

Outcome Measures

Primary Outcomes (4)

• 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".

  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".

  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".

  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".

  Month 12

Secondary Outcomes (8)

• Change in the self-reported disability level - Questionnaire A

  Week 6

• Change in the self-reported disability level - Questionnaire A

  Month 4

• Change in the self-reported disability level - Questionnaire A

  Month 8

• Change in the self-reported disability level - Questionnaire A

  Month 12

• Change in the self-reported disability level - Questionnaire B

  Week 6

Other Outcomes (10)

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

  Month 12

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

  Month 12

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

  Month 12

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will be instructed to follow their current low back pain management program, in addition, they will be instructed to wear a lumbar brace (Horizon 627 Lumbar Brace) during the day for four weeks only when they are in pain in addition to their current management program.

Device: Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618

Control

NO INTERVENTION

Participants will be instructed to follow their current low back pain management program.

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years
• Ambulatory
• Able to read and understand English
• Living in Edmonton
• Presenting to an emergency department

You may not qualify if:

• 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
• On-going workers' compensation or litigation cases

Sponsors & Collaborators

• University of Alberta: lead
• Curtin University: collaborator
• American Orthotic and Prosthetic Association: collaborator

Study Sites (1)

Royal Perth Hospital

Perth, Australia

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Emergencies; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Vahid Abdollah, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vahid Abdollah, PhD

CONTACT

7804928889; v.abdollah@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of each intervention, blinding will not be feasible for participants. However, outcomes assessor and adjudicators, as well as the statistician, will be blinded to the actual allocation. The investigators will develop two interpretations of our results based on a blinded review of the primary outcome data (intervention A vs. intervention B). One scenario will assume intervention A was brace and the other will assume intervention A was routine recommendations. Only after our team has agreed that there will be no further changes in the interpretation of the scenarios will the randomisation code be broken, and the correct interpretation used in manuscript preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, superiority, 1:1 parallel randomised control trial with concealed allocation. Superiority will be based on a minimally clinically significant difference of our primary outcome measure (Numerical Pain Rating Scale, a 0-10 point scale).

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 4, 2019
• Study Start: June 12, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)