Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain

Last updated: December 5, 2024
Sponsor: Johns Hopkins University
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Treatment

Incrediwear 24 Hour Back Brace

Incrediwear Sham Daytime Back Brace

Control Daytime Back Brace

Clinical Study ID

NCT06126887
IRB00391930
  • Ages > 18
  • All Genders

Study 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, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.

Eligibility Criteria

Inclusion

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) outof ten (10)

  • Recommended a back brace for LBP management

  • Provide written consent for participation

  • Subject available for phone calls after 6PM

Exclusion

Exclusion Criteria:

  • Severe central spinal stenosis

  • Focal lower extremity weakness

  • LBP radiating beyond the knee and/or accompanied by neurological signs (includingsciatica)

  • 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 datarecording

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Incrediwear 24 Hour Back Brace
Phase:
Study Start date:
January 09, 2024
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Johns Hopkins Health Care & Surgery Center - Howard County Medical Center

    Columbia, Maryland 21044
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.