Incrediwear Back Brace for Lower Back Pain

Overseen By Akhil Chhatre, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Pain medication

Disqualifiers: Severe stenosis, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the Incrediwear Back Brace for individuals with chronic lower back pain (LBP). Researchers aim to determine if this brace can improve patient satisfaction, reduce the need for pain medication, and assist with daily activities more effectively than a placebo or standard brace. Participants will be divided into groups to try different types of braces, including the Incrediwear brace and a standard one. This trial targets individuals with ongoing back pain from conditions like disc herniation or scoliosis who regularly take pain medication. As an unphased trial, it offers a unique opportunity for patients to explore new treatment options for managing chronic back pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be using pain medication at least weekly for their low back pain.

What prior data suggests that the Incrediwear Back Brace is safe for use in managing lower back pain?

Research on back braces, such as the Incrediwear Back Brace, has shown they are generally safe for use. Studies have found no harmful effects from these braces. Designed to support the back and relieve pain, they have been positively received by users dealing with muscle pain and sciatica, a type of nerve pain. Users report positive experiences without major problems. So far, the Incrediwear Back Brace appears well-tolerated, making it a promising option for those with ongoing lower back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Incrediwear Back Brace is unique because it focuses on using therapeutic fabric technology to alleviate lower back pain, differing from standard options like medications and traditional lumbar braces. This treatment is distinctive because it is designed to be worn against the skin and aims to enhance circulation and reduce inflammation through the fabric itself, potentially offering a non-invasive and drug-free alternative. Unlike standard braces that primarily provide support, the Incrediwear brace's material actively works to improve the body's natural healing processes, which is why researchers are eager to see its effects.

What evidence suggests that the Incrediwear Back Brace is effective for lower back pain?

Research has shown that back braces, such as the Incrediwear Back Brace, can significantly aid individuals with ongoing lower back pain. Studies found that users of back braces experienced a 37% reduction in pain after three months, improving to 48% after a year. In this trial, participants may receive the Incrediwear Back Brace, designed to reduce swelling and ease pain, potentially accelerating recovery from lower spine issues. Other studies on Incrediwear products demonstrated a 19% decrease in swelling and a slight increase in movement. These findings suggest that the Incrediwear Back Brace could effectively manage chronic lower back pain by reducing pain and enhancing overall function. ^{1 3 4 6 7}

Who Is on the Research Team?

Akhil Chhatre, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide written consent for participation

My pain level is more than 3 out of 10.

I have been treated for back pain due to a specific spine condition.

Exclusion Criteria

I have been diagnosed with peripheral arterial disease.

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

I have a severe narrowing of my spinal canal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of four study groups and wear the assigned back brace for a full 4-week duration

4 weeks

Data collected through phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Incrediwear Back Brace

Trial Overview

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.

How Is the Trial Designed?

Group I: Incrediwear Daytime Experimental Treatment 1 Intervention

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

Group II: Incrediwear 24 hour Active Control 1 Intervention

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

Group III: Incrediwear Sham Daytime Placebo Group 1 Intervention

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

Group IV: Control Daytime Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

All four types of lumbar braces significantly limit motion in the lumbar and thoracic regions, with the rigid TLSO and Raney jackets providing the most restriction compared to the Camp corset and elastic corset.

There is a trade-off between comfort and motion restriction; the elastic corset was rated the most comfortable, while the Raney jacket was the least comfortable, highlighting that more restrictive braces tend to be less comfortable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional spinal motion measurements. Part 2: A noninvasive assessment of lumbar brace immobilization of the spine. Buchalter, D., Kahanovitz, N., Viola, K., et al.[2022]

The sacroiliac belt was associated with significantly higher user satisfaction compared to the lumbar orthosis, with a QUEST score of 20.31 versus 16.17, indicating that users preferred the sacroiliac belt during the study.

Both the sacroiliac belt and lumbar orthosis showed similar effectiveness in managing pain and functional disability, but higher satisfaction with the sacroiliac belt correlated with improvements in pain magnitude and frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Sacroiliac Belt versus Lumbar Orthosis Utilization on Nonspecific Low Back Pain: a Crossover Randomized Clinical Trial. Lee, DJ., Ahmed, SA., Tang, OY., et al.[2022]

The Boston Brace System effectively realigns the scoliotic spine and has shown a 90% success rate in treating back injuries among 31 young athletes over an average follow-up of 15 months.

While the brace provided excellent results for conditions like spondylolysis, it was less effective for discogenic back pain, achieving success in only 50% of those cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of modified Boston brace for back injuries in athletes. Micheli, LJ., Hall, JE., Miller, ME.[2017]

Citations

1.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06126887/evaluation-of-efficacy-and-comfort-a-trial-on-the-incrediwear-back-brace-in-patients-with-chronic-lower-back-pain

A Trial on the Incrediwear Back Brace in Patients With ...

While back braces have been recommended as part of LBP management, their efficacy and impact on patient outcomes remain uncertain.

2.

withpower.com

withpower.com/trial/phase-back-pain-10-2023-473a8

Incrediwear Back Brace for Lower Back Pain

The Boston Brace System effectively realigns the scoliotic spine and has shown a 90% success rate in treating back injuries among 31 young athletes over an ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11591956/

Efficacy of Back Bracing in Treating Chronic Low Back Pain

VAS scores improved and decreased by 37% at three months, 42% at six months, and 48% at twelve months.

4.

supplypt.com

supplypt.com/pages/scientific-research-behind-incrediwear?srsltid=AfmBOopWYn6qKB3z67yLWxun6vgOMpQN8GlW9w5rBR30As_vs6AWlgII

Scientific Research Behind Incrediwear

The findings were compelling: those using Incrediwear sleeves experienced 19% less swelling and a 4% increase in range of motion at 21 days post-surgery.

5.

amazon.com

amazon.com/Incrediwear-Back-Brace-Sciatica-Herniated/dp/B09X11CLJS

Amazon.com: Incrediwear Back Brace

Back support brace for back pain relief from muscle pain, sciatica or a herniated disc, everyday lower back lumbar support.

6.

incrediwear.com

incrediwear.com/products/back-brace-2022-redesign?srsltid=AfmBOorTSoxgjG6nKZ6KPXP9TzGe9bz7XpR6v-dC2txVR7u82eRBetm3

Back Brace for Support & Circulation

Shop Incrediwear's Back Brace, specially designed to provide back support while accelerating recovery from lumbar injuries, conditions, & for back pain ...

7.

incrediwear.com

incrediwear.com/collections/back-problems?srsltid=AfmBOopwLQVfsZ8ZJEkri-q77cg_Iz9V4Zvjd3Cnb7pPPTsiioDyzDXv

Back Pain Relief Products

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