What side effects are associated with this type of intervention?

Common treatments for back pain, such as back braces, can have side effects including discomfort, skin irritation, and potential muscle atrophy with prolonged use. While back braces like the Incrediwear Back Brace are designed to improve adherence and reduce pain, they may also affect balance and function, particularly with rigid designs. Other non-surgical treatments, such as NSAIDs, can cause gastrointestinal, renal, and cardiovascular issues. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved various treatments for back pain, including non-surgical options such as supportive braces and pain relief technologies. For instance, lumbar support braces are commonly used to provide stability and reduce pain in patients with chronic lower back pain. Additionally, the FDA has approved transcutaneous electrical nerve stimulation (TENS) devices, which use electrical impulses to relieve pain. While specific approvals for products like the Incrediwear Back Brace are not detailed, similar supportive and pain reduction technologies have been recognized for their efficacy in managing back pain.

What other types of research exist?

Promising alternatives to Incrediwear's Back Brace for back pain patients include: 1) Smart braces with electronic monitoring to improve compliance and effectiveness, 2) Advanced lumbar support garments designed for ergonomic needs and comfort, 3) Customizable pressure-reducing cushions for improved posture and support, and 4) Therapeutic exercise programs tailored for chronic pain and performance improvement.

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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)

Must not have

Diagnosed peripheral arterial disease

Higher functions do not enable proper comprehension of protocol or reliable data recording

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Summary

This trial is testing a special back brace from Incrediwear on patients with chronic low back pain who don't need surgery. The brace aims to support the lower back and improve blood flow, potentially reducing pain and improving movement. The study will evaluate the effectiveness of this brace.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with peripheral arterial disease.

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I might struggle to understand or follow the study's requirements.

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I have a severe narrowing of my spinal canal.

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I have weakness in my legs.

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My lower back pain is due to inflammation, a tumor, or an infection.

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I cannot take certain pain relievers, anti-inflammatories, or anxiety medications.

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I have diabetes.

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My lower back pain extends beyond my knee or comes with nerve symptoms.

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My lower back pain is due to a work-related injury.

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I have had spinal fusion surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lumbar supports and braces, like Incrediwear's Back Brace, work by stabilizing the spine, reducing trunk motion, and providing support to alleviate pain. This can help reduce inflammation and prevent further injury. NSAIDs reduce inflammation and pain by inhibiting enzymes involved in the inflammatory process. Physical therapy focuses on strengthening core muscles, improving flexibility, and promoting proper posture, which can alleviate pain and prevent recurrence. Multidisciplinary approaches, including psychological therapies and education, address the biopsychosocial aspects of pain, helping patients manage pain more effectively. These treatments are crucial for back pain patients as they offer non-invasive options to reduce pain, improve function, and enhance quality of life.

Cell therapy for the degenerating intervertebral disc.Regarding the controversy of lumbosacral supports and braces - an update.Lumbar motion changes in chronic low back pain patients: a secondary analysis of data from a randomized clinical trial.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,307 Previous Clinical Trials

14,861,809 Total Patients Enrolled

12 Trials studying Back Pain

4,364 Patients Enrolled for Back Pain

Akhil Chhatre, MDPrincipal InvestigatorJohns Hopkins School of Medicine

3 Previous Clinical Trials

95 Total Patients Enrolled

~27 spots leftby Dec 2024

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