Lumbar Brace for Back Pain

Recruiting at 1 trial location

Overseen By Vahid Abdollah, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Cancer, Spinal infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether wearing a lumbar brace can reduce back pain and the need for painkillers. Individuals dealing with low back pain and frequently using painkillers might find this trial of interest. The trial compares two groups: one will maintain their usual pain management, while the other will also use a lumbar brace (a supportive device worn around the lower back) during pain episodes for four weeks. Participants should have visited an emergency department for back pain and reside in Edmonton. As an unphased trial, this study provides participants the chance to explore a non-drug approach to managing 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 prior data suggests that this lumbar brace is safe for managing low back pain?

Research shows that lumbar braces are generally safe for people with back pain. They are often used for conditions like scoliosis and to support recovery after surgery. Studies have found that these braces can help reduce back pain and improve posture, leading to less reliance on painkillers.

Regarding safety, lumbar braces are well-tolerated, with no major side effects reported in studies on their use for back pain. By limiting movement, they can reduce pain and enhance mobility. This may also decrease the need for medications like opioids, which can have serious side effects. Thus, lumbar braces provide a safe, drug-free method for managing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lumbar brace for back pain because it offers a non-invasive way to potentially manage discomfort. Unlike standard treatments like physical therapy or pain medication, this brace is worn only when pain occurs, providing support and potentially reducing the need for frequent medication. Its targeted use could minimize side effects commonly associated with long-term medication use, offering a more tailored approach to pain management. Additionally, the brace's convenience and ease of use during daily activities make it an appealing option for those seeking immediate relief without altering their existing routines.

What evidence suggests that a lumbar brace is effective for low back pain?

Research shows that lumbar braces can help manage low back pain by supporting the spine and improving posture. In this trial, participants in the intervention arm will wear a lumbar brace alongside their current management program. Recent studies found that patients using these braces often needed fewer painkillers. The brace acts like crutches for the back, limiting movement and possibly reducing discomfort. Wearing the brace may lead to less pain and improved spine function. These benefits can help lower the need for pain medications and reduce future doctor visits. ^{2 3 6 7 8}

Who Is on the Research Team?

Greg Kawchuk, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

Able to read and understand English

Living in Edmonton

Presenting to an emergency department

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lumbar Brace Deployment

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Lumbar Brace for:

• Benign low back pain
• Spinal stabilization
• Prevention of excessive spinal motion

Approved in European Union as Lumbar Orthosis for:

• Low back pain management
• Spinal support
• Postural correction

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+

Curtin University

Collaborator

Trials

28

Recruited

81,400+

American Orthotic and Prosthetic Association

Collaborator

Trials

5

Recruited

260+

Published Research Related to This Trial

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 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]

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]

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]

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 62 patients with chronic low back pain and Modic type 1 changes, 79% experienced at least a 30% reduction in pain after using a custom-made rigid lumbar brace for 3 months.

Despite the initial pain relief, 30 out of 46 patients experienced a recurrence of pain two months after the brace was removed, indicating that while the brace may provide temporary relief, further research is needed to understand its long-term effectiveness.

NCBI (Pubmed)

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. Boutevillain, L., Bonnin, A., Chabaud, A., et al.[2019]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6315306/

Effectiveness of lumbar orthoses in low back pain The lumbar support should improve the proprioception and lead to more stabilization. Furthermore, the resulting heat on the trunk leads to hyperemia, which ...

2. hudsonvalleyscoliosis.com hudsonvalleyscoliosis.com/adult-scoliosis/treatments/

Scoliosis Treatment In Adults: How To Stabilize Your Curve This innovative new design is reducing pain, improving postural appearance, and can even prevent postural collapse from happening. We ALWAYS combine use of the ...

3. aetna.com aetna.com/cpb/medical/data/300_399/0398.html

Idiopathic Scoliosis - Medical Clinical Policy Bulletins In the control group of the Boston full-time brace patients, brace correction was 50 % and the progression of the major curve occurred in 22 % of the patients.

4. spine-health.com spine-health.com/conditions/scoliosis/types-scoliosis-braces

Types of Scoliosis Braces Various scoliosis braces, like boston, TLSO, and nighttime brace are designed to correct spinal curves and provide support for those with scoliosis.

5. amazon.com amazon.com/Corrector-Straightener-Scoliosis-Correction-Adjustable/dp/B09ZQ2QSXS

Fit Geno Back Brace Posture Corrector for Women and ... Featuring four removable fiberglass support rods, it straightens your spine, reduces shoulder and neck pressure, and promotes spinal health for comprehensive ...

6. amazon.com amazon.com/Lumbar-Support-Back-Brace-Women/dp/B07ZZCRGZP

Lumbar Support Back Brace for Men and Women (Plus ... Brand. Bodyprox · Size. Plus Size 50" - 70" · Specific Uses For Product. Holding,Pain Relief,Herniated Disc,Sciatica,Lumbar Support,Osteoporosis,Nerve,Skin · Use ...

7. californiapain.com californiapain.com/back-brace/

Back Brace: 5 Powerful Picks That Truly Work in 2025 Provides up to 52 days of reduced back pain per year. Common Uses: Lower back pain relief; Posture correction; Post-surgical support; Sports and heavy lifting ...

8. physio-pedia.com physio-pedia.com/Milwaukee_brace

Milwaukee brace The Milwaukee brace is an active corrective spinal orthosis. It consists of a neck ring with a throat mould and two occipital pads to avoid a high pressure ...