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

NCT06126887 | Completed

• 1 other identifier: IRB00391930
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (4)

Incrediwear Daytime

EXPERIMENTAL

Incrediwear back brace worn 7AM-7PM (against skin)

Device: Incrediwear Daytime Back Brace

Incrediwear Sham Daytime

SHAM COMPARATOR

Incrediwear sham back brace worn 7AM-7PM (against skin)

Device: Incrediwear Sham Daytime Back Brace

Control Daytime

PLACEBO COMPARATOR

Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM

Device: Control Daytime Back Brace

Incrediwear 24 hour

ACTIVE COMPARATOR

Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin)

Device: Incrediwear 24 Hour Back Brace

Interventions

Incrediwear Daytime Back Brace DEVICE

Incrediwear Daytime Back Brace

Incrediwear Daytime

Incrediwear Sham Daytime Back Brace DEVICE

Incrediwear Sham Daytime Back Brace

Incrediwear Sham Daytime

Control Daytime Back Brace DEVICE

Control Daytime Back Brace

Control Daytime

Incrediwear 24 Hour Back Brace DEVICE

Incrediwear 24 Hour Back Brace

Incrediwear 24 hour

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Health Care & Surgery Center - Howard County Medical Center

Columbia, Maryland, 21044, United States

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Akhil Chhatre, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 13, 2023
• Study Start: January 9, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)