NCT06126887

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Low Back Pain
• Back Pain

Interventions

Type	Name	Description
DEVICE	Incrediwear Daytime Back Brace	Incrediwear Daytime Back Brace
DEVICE	Incrediwear Sham Daytime Back Brace	Incrediwear Sham Daytime Back Brace
DEVICE	Control Daytime Back Brace	Control Daytime Back Brace
DEVICE	Incrediwear 24 Hour Back Brace	Incrediwear 24 Hour Back Brace

Timeline

• Start date: 2024-01-09
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2023-11-13
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States