Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
NCT ID: NCT06126887
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-01-09
2024-11-30
Brief Summary
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Detailed Description
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Research Hypothesis: 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, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.
Importance of the Research: This randomized clinical trial aims to assess the efficacy of Incrediwear's Back Brace in improving patient outcomes for chronic LBP. The study will provide valuable insights into the utilization patterns and adherence of back braces, patient satisfaction with treatment protocols, and the impact of brace usage on pain medication consumption and functional disability. By evaluating these factors through a controlled trial, the investigators seek to enhance the understanding of effective LBP management strategies, potentially reducing the burden of chronic LBP on patients and healthcare systems.
The study will be conducted under the guidance of Dr. Akhil Chhatre, Principal Investigator at the Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine. The research will involve 100 non-surgical chronic LBP patients meeting specific inclusion criteria. The patients will be randomly assigned to one of four study groups, and data will be collected through phone calls over a full 4-week duration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Incrediwear Daytime
Incrediwear back brace worn 7AM-7PM (against skin)
Incrediwear Daytime Back Brace
Incrediwear Daytime Back Brace
Incrediwear Sham Daytime
Incrediwear sham back brace worn 7AM-7PM (against skin)
Incrediwear Sham Daytime Back Brace
Incrediwear Sham Daytime Back Brace
Control Daytime
Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM
Control Daytime Back Brace
Control Daytime Back Brace
Incrediwear 24 hour
Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin)
Incrediwear 24 Hour Back Brace
Incrediwear 24 Hour Back Brace
Interventions
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Incrediwear Daytime Back Brace
Incrediwear Daytime Back Brace
Incrediwear Sham Daytime Back Brace
Incrediwear Sham Daytime Back Brace
Control Daytime Back Brace
Control Daytime Back Brace
Incrediwear 24 Hour Back Brace
Incrediwear 24 Hour Back Brace
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Akhil Chhatre, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
Columbia, Maryland, United States
Countries
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Other Identifiers
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IRB00391930
Identifier Type: -
Identifier Source: org_study_id