Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
Launched by JOHNS HOPKINS UNIVERSITY · Nov 6, 2023
Trial Information
Current as of October 01, 2025
Completed
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and comfort of a special back brace called Incrediwear's Back Brace for people with chronic lower back pain. Researchers want to see if this brace can help patients stick to wearing it, feel more satisfied, use less pain medication, and improve their ability to do daily activities. Participants will be compared to those using a regular back brace and a sham brace (which looks like a real brace but doesn't provide support) to find out which option works best.
To join the study, participants must be over 18 years old and have had ongoing lower back pain for more than a month, with specific conditions like a herniated disc or arthritis. They should also use pain medication weekly and report a pain level of over 3 out of 10 at the start of the trial. Those who qualify will participate in phone calls after 6 PM to help with the study. It's important to note that certain health conditions, like severe spinal problems or recent surgeries, may prevent someone from participating. Overall, this trial aims to help improve treatment options for people suffering from chronic back pain.
Gender
ALL
Eligibility criteria
- 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
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbia, Maryland, United States
Patients applied
Trial Officials
Akhil Chhatre, MD
Principal Investigator
Johns Hopkins School of Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported