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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Incrediwear Daytime 		Incrediwear back brace worn 7AM-7PM (against skin)
  • Device: Incrediwear Daytime Back Brace
    Incrediwear Daytime Back Brace
Sham Comparator
Incrediwear Sham Daytime 		Incrediwear sham back brace worn 7AM-7PM (against skin)
  • Device: Incrediwear Sham Daytime Back Brace
    Incrediwear Sham Daytime Back Brace
Placebo Comparator
Control Daytime 		Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM
  • Device: Control Daytime Back Brace
    Control Daytime Back Brace
Active Comparator
Incrediwear 24 hour 		Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin)
  • Device: Incrediwear 24 Hour Back Brace
    Incrediwear 24 Hour Back Brace

Recruiting Locations

Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
Columbia, Maryland 21044
Contact:
Akhil Chhatre, MD
443-561-4201
achhatr1@jhmi.edu

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Akhil Chhatre, MD
4435614201
acchatr1@jhmi.edu

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.