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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the Incrediwear Back Brace treatment for lower back pain?

Research suggests that lumbar braces can be effective for acute low-back pain and may reduce work days lost due to back pain in workers with a history of back injury. However, they are not effective for chronic low-back pain. ^{1 2 3 4 5}

Is the Incrediwear Back Brace safe for humans?

Research on various back braces, including lumbosacral corsets and lumbar braces, suggests they are generally safe for humans. They do not have adverse effects on muscle strength and may help reduce lost work time due to back injuries. ^{1 2 6 7 8}

How does the Incrediwear Back Brace treatment differ from other treatments for lower back pain?

The Incrediwear Back Brace is unique because it likely focuses on comfort and flexibility, unlike more rigid braces that restrict movement significantly. This could make it more comfortable for everyday use while still providing support for lower back pain. ^{2 3 4 9 10}

What is the purpose of this trial?

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.

Research Team

Akhil Chhatre, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 14: brace therapy as an adjunct to or substitute for lumbar fusion. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional spinal motion measurements. Part 2: A noninvasive assessment of lumbar brace immobilization of the spine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of modified Boston brace for back injuries in athletes. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

First results of pain treatment in scoliosis patients using a sagittal realignment brace. [2006]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Immediate Outcomes and Benefits of 3D Printed Braces for the Treatment of Adolescent Idiopathic Scoliosis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Quantitative measurement of spinal brace use and compliance in the treatment of adolescent idiopathic scoliosis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The influence of prophylactic orthoses on abdominal strength and low back injury in the workplace. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Psychosocial adaptation to wearing the Milwaukee brace for scoliosis. A pilot study of adolescent females and their mothers. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Sacroiliac Belt versus Lumbar Orthosis Utilization on Nonspecific Low Back Pain: a Crossover Randomized Clinical Trial. [2022]

10. Sweden pubmed.ncbi.nlm.nih.gov

Compliance and subjective relief by corset treatment in chronic low back pain. [2015]