Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
CompletedNot applicableNCT06126887
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluation of Efficacy and Comfort: A Randomized Clinical Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
- Conditions
- Interventions
- Device: Incrediwear Daytime Back Brace
- Device: Incrediwear Sham Daytime Back Brace
- Device: Control Daytime Back Brace
- Device: Incrediwear 24 Hour Back Brace
- Sponsor
- Johns Hopkins University
- Start date
- 2024-01-09
- Primary completion
- 2024-11-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06126887