Benefit of Lumbar Bracing for Chronic Low Back Pain Due to Degenerative Disc Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-14

Study Completion Date

2019-09-30

Brief Summary

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The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to study patients with uncomplicated CLBP without symptoms of radiculopathy or neurogenic claudication.

The secondary objectives of the study are to evaluate if a back brace provides any additive benefit to usual care consisting of exercise and patient education in patients with CLBP due to degenerative disc disease.

Specific Aim 1. To evaluate the effectiveness of back brace to improve pain and patient-reported functional measures in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy.

Hypothesis 1. Back brace in addition to usual care will provide statistically significant improvement in pain and functional measures compared to usual care alone.

Specific Aim 2. To evaluate the adherence to back brace wear instructions in patients with uncomplicated CLBP due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy Hypothesis 2. Patients with CLBP, due to degenerative disc and degenerative joint disease without associated symptoms of neurogenic claudication or lumbosacral radiculopathy, who are prescribed a back brace, will demonstrate clinically acceptable rates of adherence to brace wear instructions.

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Detailed Description

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Physiatrists use back braces (lumbar support, back corset, semi-rigid brace, and lumbar orthotic) for symptomatic management of patients' chronic low back pain (CLBP) despite very poor evidence supporting their use in the few published studies that have examined them. Evidence supporting back braces in other populations, such as pregnant women, and patients with sub-acute or acute low back pain, is better established. However, the benefits of back braces in the CLBP population are very unclear.

A Cochrane review on the role of lumbar supports in treating chronic LBP revealed that limited evidence was available, which led to the conclusion that, "it remains unclear whether lumbar supports are more effective than no or other interventions for treating low-back pain." The research emphasized the need for high quality randomized trials evaluating the effectiveness of back braces, and also recommended that compliance of brace wear be monitored.

The mechanism by which back braces might help patients with CLBP is also unclear. The semi-rigid design of the commonly used back brace does not mechanically limit movement enough to suggest that movement limitation is the mechanism by which back braces provide relief. However, some studies have suggested that back braces help patients with CLBP by providing postural support or a kinesthetic reminder of their posture. Using posturography, Munoz et al., studied the forces applied by lumbar bracing and concluded that back braces seem to help by improving the quality of balance strategy used by the patient. Another mechanism by which back braces are believed to help patients is by providing warmth underneath the brace.

There is poor published information regarding adherence to instructions (compliance) about the use of back braces. Based on the investigators' anecdotal clinical experience, adherence rates vary widely among patients who are prescribed back braces, ranging from non-use to constant use around the clock. Poor adherence to instructions can be a significant factor resulting in inconclusive evidence supporting the role of back brace in patients with CLBP. A recent study showed that a strong predictor for consistent adherence to back brace usage was a positive attitude towards it. In this study, positive attitude towards the back brace explained 41% of the variance in outcomes. In addition, investigators found that perceived benefit from the brace outweighed any subjective discomfort.

Back braces have been used as adjunctive therapy in addition to other conservative care options. A recent study evaluated the cumulative effect of bracing to exercise and found that bracing helps to increase trunk stiffness and augments muscle contractions, which may remind the patients to better comply with exercise instructions. This suggested a potential synergistic effect of bracing and exercise in the management of patients with CLBP.

Conditions

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Degenerative Disc Disease Lumbar Spondylosis Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, randomized controlled trial. Blinding of the subjects is not possible because a back brace is a visibly obvious intervention. In addition, since we are evaluating the adherence of back brace wear, blinding of the investigator is also not possible. Therefore, this study will be an unblinded RCT.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Study participants will not receive a back brace but will receive back school education and the same physical therapy exercise instruction as the treatment group.

Group Type ACTIVE_COMPARATOR

Back school

Intervention Type BEHAVIORAL

Back school consists of patient education physical therapy exercise instruction.

Treatment Group

Study participants in this group will receive a lumbar support back brace and will receive back school education and the same physical therapy exercise instruction as the control group.

Group Type EXPERIMENTAL

Lumbar back brace

Intervention Type OTHER

A brace that supports the lumbar region of the spine.

Back school

Intervention Type BEHAVIORAL

Back school consists of patient education physical therapy exercise instruction.

Interventions

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Lumbar back brace

A brace that supports the lumbar region of the spine.

Intervention Type OTHER

Back school

Back school consists of patient education physical therapy exercise instruction.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of lumbar degenerative disc disease or joint disease
* Low back pain \> 6 weeks
* Uncomplicated low back pain without symptoms of pain radiating below the knee

Exclusion Criteria

* Lumbar radiculopathy
* Neurogenic claudication
* Spondylolisthesis with instability
* Previous lumbar spine surgery
* Recent (\<1 year) brace use or physical therapy program
* No active psychiatric illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No