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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126887
• Other study ID #: IRB00391930
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Akhil Chhatre, MD
• Phone: 4435614201
• Email: acchatr1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Incrediwear Daytime Back Brace
Incrediwear Daytime Back Brace
• Incrediwear Sham Daytime Back Brace
Incrediwear Sham Daytime Back Brace
• Control Daytime Back Brace
Control Daytime Back Brace
• Incrediwear 24 Hour Back Brace
Incrediwear 24 Hour Back Brace

Locations

Country	Name	City	State
United States	Johns Hopkins Health Care & Surgery Center - Howard County Medical Center	Columbia	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Brace and sleeve utilization	Self-reported hours worn	1 month
Primary	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
Primary	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
Primary	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
Primary	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