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

No results posted yet for this study

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

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126887 on ClinicalTrials.gov