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

April 9, 2023 updated by: Thiru Annaswamy, Dallas VA Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: Back school
Back school consists of patient education physical therapy exercise instruction.
Experimental: 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.
Behavioral: Back school
Back school consists of patient education physical therapy exercise instruction.
Other: Lumbar back brace
A brace that supports the lumbar region of the spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Diary
Time Frame: Change between baseline and each week for 6 weeks

Patients rate their weekly pain on a scale from 0-10. Lower values indicate better outcomes.

Average weekly pain scores were compared from baseline to 6 week mark.
Change between baseline and each week for 6 weeks
Pain Disability Questionnaire
Time Frame: These assessments were made at baseline (T₀), 6 wks (T₁), 12 wks (T₂), and 6 mos (T₃). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).

Measures how pain affects the patients lifestyle and participation in activities.

Ranges from 0-150. Higher values indicate worse outcome.
These assessments were made at baseline (T₀), 6 wks (T₁), 12 wks (T₂), and 6 mos (T₃). Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months).
PROMIS Instrument Questionnaire
Time Frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
Patient reported outcome measure that measures how their pain problem is interfering with their quality of life and function. Higher scores indicate worse outcomes. Higher scores = more pain interference with function, range = 0-112
Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
European Qualify of Life (EQ-5D) Questionnaire
Time Frame: Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)
Measures quality of life for pre- and post comparisons. Higher scores indicate better outcomes. higher scores = poorer quality of life, range = 0-10
Change between baseline and each follow-up visit (6 weeks, 12 weeks and 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Collaborators

Aspen Medical Products

Investigators

  • Principal Investigator: Thiru Annaswamy, M.D., Dallas VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2015

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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