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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Low Back Pain
• Intervention / Treatment: Device: Incrediwear Daytime Back Brace; Device: Incrediwear Sham Daytime Back Brace; Device: Control Daytime Back Brace; Device: Incrediwear 24 Hour Back Brace

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Johns Hopkins Health Care & Surgery Center - Howard County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)	Satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 [QUEST 2.0] score). The score ranges from 1-5 with 1 being not satisfied at all to 5 being very satisfied	1 month
Brace and sleeve utilization	Self-reported hours worn	1 month
Pain medication name	The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication name	1 month
Functional disability status as assessed by the Oswestry Disability Index (ODI)	Oswestry Disability Index (ODI). A total score of 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), 35-50 (completely disabled)	1 month
Pain as assessed by the Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) and frequency (ordinal scale). 0 = no pain and 10 = pain as bad as it could possibly be	1 month
Pain medication dosage used	The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication dosage used	1 month

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Akhil Chhatre, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB00391930

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No