Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
NCT06126887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2024-12-06
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.
Conditions
- Low Back Pain
- Back Pain
Interventions
- 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
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Akhil Chhatre, MD · Johns Hopkins School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-09
- Primary Completion
- 2024-11-30
- Completion
- 2024-11-30
Countries
- United States
Study Locations
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