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Behavioural Intervention

Incrediwear Back Brace for Lower Back Pain

N/A
Recruiting
Led By Akhil Chhatre, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Subject report a VAS pain score at the time of consent greater than three (>3) out of ten (10)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial will test a new back brace to see if it helps reduce pain & improve quality of life for people with long-term lower back pain.

Who is the study for?
This trial is for adults over 18 with chronic lower back pain from conditions like disc herniation or scoliosis, who use pain meds at least weekly. They must have had initial treatment lasting more than a month and report significant pain. Excluded are those with severe spinal issues, recent back surgery, diabetes, work-related injuries, or inability to understand the study.Check my eligibility
What is being tested?
The trial tests if Incrediwear's Back Brace improves adherence, satisfaction, reduces pain med usage and functional disability in non-surgical patients compared to a sham brace and standard brace. Participants will wear different braces during the study period to measure these outcomes.See study design
What are the potential side effects?
While not explicitly stated for this device trial, potential side effects may include skin irritation under the brace area due to prolonged wear or an allergic reaction to brace materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated for back pain due to a specific spine condition.
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My pain level is more than 3 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brace and sleeve utilization
Functional disability status as assessed by the Oswestry Disability Index (ODI)
Pain as assessed by the Visual Analogue Scale (VAS)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Incrediwear DaytimeExperimental Treatment1 Intervention
Incrediwear back brace worn 7AM-7PM (against skin)
Group II: Incrediwear 24 hourActive Control1 Intervention
Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin)
Group III: Incrediwear Sham DaytimePlacebo Group1 Intervention
Incrediwear sham back brace worn 7AM-7PM (against skin)
Group IV: Control DaytimePlacebo Group1 Intervention
Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,397 Total Patients Enrolled
11 Trials studying Back Pain
3,930 Patients Enrolled for Back Pain
Akhil Chhatre, MDPrincipal InvestigatorJohns Hopkins School of Medicine
2 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room for participants to be enrolled in this trial?

"According to the material posted on clinicaltrials.gov, this trial is in its recruitment phase and was first introduced on November 1st 2023 with a recent edit date of November 6th 2023."

Answered by AI

How many individuals have joined the clinical trial thus far?

"Affirmative. The data found on clinicaltrials.gov shows that this research study, which was published on November 1st 2023, is actively searching for participants. Approximately 100 patients need to be recruited across a single medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

30 + yrs of pain. No relief.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
2024. "Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126887.
All > Low Back Pain > Lower Back Pain
~40 spots leftby Jun 2024
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