Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID03829631

Lumbar Brace Deployment in The Emergency Department for Benign Low Back Pain: Effectiveness and Impact on Pain, Spine Function, Analgesic Use and Community Resources

Led by University of Alberta · Updated on 2026-02-02

152

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

A

American Orthotic and Prosthetic Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

Low back pain is a widespread condition causing significant health care costs, often without a clear cause. This research evaluates whether wearing a lumbar brace after emergency department visits for benign low back pain can reduce pain, improve spine function, decrease painkiller use including opioids, and lower future health care resource use. The study is a randomized controlled trial aiming to provide emergency staff with better pain control options beyond medications. Participants with benign low back pain will be randomly assigned to either wear a semi-rigid lumbar brace for six weeks during the day along with their usual care or to continue their current back pain management without a brace. The brace is adjustable to fit various waist sizes and is designed to limit lumbar spine movement without restricting overall spinal function. Both groups will be monitored over time with data collected through questionnaires and electronic monitoring of brace use. Participants will complete self-reported surveys measuring pain and disability at baseline and at multiple follow-up points up to 12 months. A temperature and force sensor in the brace will track how long and how tightly it is worn. Text messages will be sent three times per week for four weeks to gather ongoing data about pain, function, brace use, and painkiller consumption. Researchers will also analyze health care use data from the year before and during the study to explore broader impacts. The study is designed with blinded outcome assessors and statisticians to reduce bias.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 65 years
  • Ambulatory
  • Able to read and understand English
  • Living in Edmonton
  • Presenting to an emergency department
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants in the intervention group will be instructed to wear a semi-rigid lumbar brace during the day for up to 6 weeks while following their usual low back pain management program. Participants in the control group will continue their usual low back pain management without the brace.

Initial fitting visit for brace wearers; participants receive SMS text messages 3 times per week for 4 weeks to report pain, function, brace usage, and analgesic consumption

Follow-up

Duration - Up to 12 months

Participants will continue to report pain levels, disability, and analgesic use through SMS at 2 and 3 months after the treatment period. Additionally, health care resource use will be monitored for one year using health records with participant consent.

SMS assessments at 2 and 3 months; health record monitoring throughout the year

Trial Site Locations

Total: 1 location

1

Royal Perth Hospital

Perth, Australia

Actively Recruiting

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Research Team

V

Vahid Abdollah, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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