Lumbar Brace for Back Pain

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Greg Kawchuk, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: Cancer, Spinal infection, Pregnancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if wearing a lumbar brace for a few weeks can help people with low back pain who visit the emergency department. The brace supports the lower back, reducing movement and pain. This may decrease the need for painkillers and improve daily function. Lumbar supports are used in the treatment of low-back pain patients to prevent the onset or recurrence of low-back pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a lumbar brace to manage back pain, which may reduce the need for painkillers.

What data supports the effectiveness of the Lumbar Brace Deployment treatment for back pain?

Research shows that the Boston brace, a type of lumbar brace, has been effective in managing back injuries in young athletes, with 90% of cases showing good or excellent results. Additionally, lumbar braces like the Boston brace have been used successfully in the conservative treatment of scoliosis, indicating their potential to support the spine and reduce pain. ^{1 2 3 4 5}

Is the lumbar brace generally safe for humans?

The studies indicate that lumbar braces, including the Boston brace, are generally safe for humans. They restrict spinal motion, which can be uncomfortable, but no significant safety concerns were reported in the research. ^{1 2 6 7 8}

How does the Lumbar Brace Deployment treatment differ from other treatments for back pain?

Lumbar braces, such as the Boston brace and TLSO, are unique in their ability to restrict spinal motion, particularly in the frontal plane, which can help manage back pain by limiting movement and providing support. Unlike other treatments, these braces offer a non-invasive option that can be adjusted to the patient's specific needs, although there is often a trade-off between the level of motion restriction and comfort. ^{1 6 8 9 10}

Research Team

Greg Kawchuk, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for individuals aged 18-65 in Edmonton who can walk and understand English, presenting to an emergency department with low back pain. It's not suitable for those outside this age range or unable to meet the criteria.

Inclusion Criteria

I am between 18 and 65 years old.

I can walk on my own without help.

Able to read and understand English

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Session

Collection of demographics, comorbidities, medication, and self-reported histories of imaging and treatment. Randomization to brace or no brace groups.

1 day

1 visit (in-person)

Treatment

Participants in the intervention group wear a semi-rigid lumbar brace for 4 weeks. Both groups continue their current low back pain management program.

4 weeks

Weekly SMS evaluations

Follow-up

Participants are monitored for pain, disability, and healthcare resource utilization. SMS evaluations at 2 and 3 months.

12 months

SMS evaluations at 2 and 3 months

Treatment Details

Interventions

• Lumbar Brace Deployment (Brace)

Trial Overview The study tests if wearing a Horizon 627 Lumbar Brace from Aspen Medical reduces pain and improves spine function in people with low back pain, potentially cutting down on painkiller use.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants will be instructed to follow their current low back pain management program, in addition, they will be instructed to wear a lumbar brace (Horizon 627 Lumbar Brace) during the day for four weeks only when they are in pain in addition to their current management program.

Group II: Control Active Control 1 Intervention

Participants will be instructed to follow their current low back pain management program.

Lumbar Brace Deployment is already approved in Canada for the following indications:

Approved in Canada as Thoracolumbosacral Orthosis for:

• Spinal stabilization
• Low back pain relief
• Prevention of spinal deformities

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Curtin University

Collaborator

Trials

28

Recruited

81,400+

American Orthotic and Prosthetic Association

Collaborator

Trials

5

Recruited

260+

Findings from Research

In a study of 10 patients with idiopathic scoliosis, pure lumbar flexion was found to reduce primary and secondary curves by 6 degrees and 8 degrees, respectively.

The Boston Thoracic Brace was more effective, achieving reductions of 16 degrees for primary curves and 14 degrees for secondary curves, highlighting the importance of lumbar lordosis reduction in scoliosis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of lumbar flexion and Boston Thoracic Brace on the curves in idiopathic scoliosis. Udén, A., Willner, S.[2019]

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]

In a study of 90 adolescents with idiopathic scoliosis treated with TLSO braces, those who did not receive repeat in-brace x-rays for adjustments were 3.1 times more likely to experience brace failure, indicating the importance of regular monitoring for effective treatment.

Patients who lacked consistent radiographic documentation of in-brace correction tended to be more skeletally immature, wore more braces, and had longer treatment durations, all of which were associated with higher rates of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of in-brace x-rays in compliant AIS patients wearing full-time TLSO braces associates with failure. Alvarez, I., Poppino, K., Karol, L., et al.[2022]

In a study of 64 patients with adolescent idiopathic scoliosis, an initial correction of over 50% using the Boston brace was linked to a permanent reduction in spinal curvature by an average of 7.2 degrees after about 4.8 years.

The effectiveness of the Boston brace in treating scoliosis was maintained even when the brace design was altered from a straight lumbar profile to one with 15 degrees of lumbar lordosis, indicating its robust corrective ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boston brace in the treatment of idiopathic scoliosis. Olafsson, Y., Saraste, H., Söderlund, V., et al.[2022]

A new variable lumbar orthosis has been developed that allows patients to adjust abdominal and lumbar support according to their changing needs, which is not available in current commercial options.

This orthosis has shown favorable results in a clinical setting for patients with low back pain, providing a tailored approach to support and immobilization based on the severity of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The variable lumbar orthosis: fabrication and guidelines for use. Basile, VJ., Goldstein, DF.[2008]

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 was found to distract the lumbar spine and correct frontal deformity in adolescents with idiopathic scoliosis, but it significantly reduced the natural curvature of the lumbar spine (lumbar lordosis).

Despite its effects on frontal alignment, the brace did not significantly improve the rotation of the apical vertebra or spinal detorsion, indicating that a more effective 3-D corrective orthosis is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[3-D study of the immediate effect of the Boston brace on the scoliotic lumbar spine]. Labelle, H., Dansereau, J., Bellefleur, C., et al.[2009]

The Boston brace effectively prevents the progression of scoliosis but does not typically achieve complete three-dimensional correction, indicating a need for better understanding of its biomechanical effects.

The study found that the in-brace spinal shape is closely linked to the patient's out-of-brace spinal deformation, suggesting that personalized adjustments to strap tensions and pressure distribution could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between strap tension, interface pressures and spine correction in brace treatment of scoliosis. Beauséjour, M., Petit, Y., Grimard, G., et al.[2022]

References

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

The effect of lumbar flexion and Boston Thoracic Brace on the curves in idiopathic scoliosis. [2019]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Lack of in-brace x-rays in compliant AIS patients wearing full-time TLSO braces associates with failure. [2022]

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

Boston brace in the treatment of idiopathic scoliosis. [2022]

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

The variable lumbar orthosis: fabrication and guidelines for use. [2008]

6. 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]

7. France pubmed.ncbi.nlm.nih.gov

[3-D study of the immediate effect of the Boston brace on the scoliotic lumbar spine]. [2009]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Relationships between strap tension, interface pressures and spine correction in brace treatment of scoliosis. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Short-term pain evolution in chronic low back pain with Modic type 1 changes treated by a lumbar rigid brace: A retrospective study. [2019]

10. 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]