Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03829631




Registration number
NCT03829631
Ethics application status
Date submitted
24/01/2019
Date registered
4/02/2019
Date last updated
18/12/2024

Titles & IDs
Public title
Lumbar Brace Deployment in the Emergency Department for Benign Low Back Pain
Scientific title
Lumbar Brace Deployment in The Emergency Department for Benign Low Back Pain: Effectiveness and Impact on Pain, Spine Function, Analgesic Use and Community Resources
Secondary ID [1] 0 0
Pro00085904
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Brace 0 0
Emergencies 0 0
Pain 0 0
Health Care Resources 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618

Experimental: Intervention - 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.

No intervention: Control - Participants will be instructed to follow their current low back pain management program.


Treatment: Devices: Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618
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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the pain level
Timepoint [1] 0 0
Week 6
Primary outcome [2] 0 0
Change in the pain level
Timepoint [2] 0 0
Month 4
Primary outcome [3] 0 0
Change in the pain level
Timepoint [3] 0 0
Month 8
Primary outcome [4] 0 0
Change in the pain level
Timepoint [4] 0 0
Month 12
Secondary outcome [1] 0 0
Change in the self-reported disability level - Questionnaire A
Timepoint [1] 0 0
Week 6
Secondary outcome [2] 0 0
Change in the self-reported disability level - Questionnaire A
Timepoint [2] 0 0
Month 4
Secondary outcome [3] 0 0
Change in the self-reported disability level - Questionnaire A
Timepoint [3] 0 0
Month 8
Secondary outcome [4] 0 0
Change in the self-reported disability level - Questionnaire A
Timepoint [4] 0 0
Month 12
Secondary outcome [5] 0 0
Change in the self-reported disability level - Questionnaire B
Timepoint [5] 0 0
Week 6
Secondary outcome [6] 0 0
Change in the self-reported disability level - Questionnaire B
Timepoint [6] 0 0
Month 4
Secondary outcome [7] 0 0
Change in the self-reported disability level - Questionnaire B
Timepoint [7] 0 0
Month 8
Secondary outcome [8] 0 0
Change in the self-reported disability level - Questionnaire B
Timepoint [8] 0 0
Month 12

Eligibility
Key inclusion criteria
* Aged between 18 and 65 years
* Ambulatory
* Able to read and understand English
* Living in Edmonton
* Presenting to an emergency department
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
American Orthotic and Prosthetic Association
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Curtin University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03829631
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Greg Kawchuk, PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Greg Kawchuk, PhD
Address 0 0
Country 0 0
Phone 0 0
17802939486
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03829631