Status:
COMPLETED
Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
Lead Sponsor:
Johns Hopkins University
Conditions:
Low Back Pain
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesize that the utilization of Incrediwear's Back Brace, compared to a sham brace and a standard-issue brace, will lead to better brace adherence, increased patient satisfaction...
Detailed Description
Problem: Chronic low back pain (LBP) affects a substantial portion of the population and often leads to decreased functional ability and increased pain medication usage. While back braces have been re...
Eligibility Criteria
Inclusion
- Male or female, age \> 18
- Has undergone treatment for an initial episode of nonspecific low back pain (LBP) lasting \> 1 month, with one of the following causative "Principle Diagnoses":
- Disc herniation
- Facet arthropathy
- Compression fracture
- Spondylolisthesis
- Sacroiliac joint dysfunction
- Scoliosis
- Mild to moderate central spinal stenosis
- Lumbar spondylosis
- Degenerative changes, not otherwise specified
- Utilize pain medication (including Step I or II analgesics, NSAIDs, Benzodiazepines) at least weekly for their LBP
- Subject report a VAS pain score at the time of consent greater than three (\>3) out of ten (10)
- Recommended a back brace for LBP management
- Provide written consent for participation
- Subject available for phone calls after 6PM
Exclusion
- Severe central spinal stenosis
- Focal lower extremity weakness
- LBP radiating beyond the knee and/or accompanied by neurological signs (including sciatica)
- Spinal operation within 5 years preceding the study date
- Secondary LBP due to a work accident (e.g. workers comp)
- History of spinal arthrodesis
- LBP with an inflammatory, tumor, or infectious cause
- Contraindications to: Step I or II analgesics, NSAIDs, Benzodiazepines
- Diagnosed peripheral arterial disease
- Diabetes
- Higher functions do not enable proper comprehension of protocol or reliable data recording
Key Trial Info
Start Date :
January 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06126887
Start Date
January 9 2024
End Date
November 30 2024
Last Update
December 6 2024
Active Locations (1)
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1
Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
Columbia, Maryland, United States, 21044