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Brace
Lumbar Brace for Back Pain
N/A
Recruiting
Led By Greg Kawchuk, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 18 and 65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if wearing a lumbar brace for a few weeks can help people with low back pain who visit the emergency department. The brace supports the lower back, reducing movement and pain. This may decrease the need for painkillers and improve daily function. Lumbar supports are used in the treatment of low-back pain patients to prevent the onset or recurrence of low-back pain.
Who is the study for?
This trial is for individuals aged 18-65 in Edmonton who can walk and understand English, presenting to an emergency department with low back pain. It's not suitable for those outside this age range or unable to meet the criteria.
What is being tested?
The study tests if wearing a Horizon 627 Lumbar Brace from Aspen Medical reduces pain and improves spine function in people with low back pain, potentially cutting down on painkiller use.
What are the potential side effects?
While the trial description doesn't list specific side effects of the lumbar brace, common issues may include discomfort, skin irritation under the brace, or muscle weakness due to reduced movement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the pain level
Secondary study objectives
Change in the self-reported disability level - Questionnaire A
Change in the self-reported disability level - Questionnaire B
Other study objectives
Change in healthcare resource utilization- allied health visits (after enrollment)
Change in healthcare resource utilization- allied health visits (before enrollment)
Change in healthcare resource utilization- imaging (after enrollment)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 Intervention
Participants will be instructed to follow their current low back pain management program.
Find a Location
Who is running the clinical trial?
Curtin UniversityOTHER
27 Previous Clinical Trials
81,224 Total Patients Enrolled
2 Trials studying Low Back Pain
341 Patients Enrolled for Low Back Pain
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,257 Total Patients Enrolled
13 Trials studying Low Back Pain
1,595 Patients Enrolled for Low Back Pain
American Orthotic and Prosthetic AssociationOTHER
4 Previous Clinical Trials
103 Total Patients Enrolled
Greg Kawchuk, PhDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
2 Total Patients Enrolled
1 Trials studying Low Back Pain
2 Patients Enrolled for Low Back Pain