Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
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About
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.
Full 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 recommended as part of LBP management, their efficacy and impact on patient outcomes remain uncertain.
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.
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Inclusion criteria
- 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 criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Akhil Chhatre, MD
Data sourced from clinicaltrials.gov
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