N/A N=59 Randomized Treatment

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

Degenerative Disc Disease · Lumbar Spondylosis · Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT03484403 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Pain Diary — 6.71; 5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lumbar back brace (Other); Back school (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dallas VA Medical Center
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Diary	6.71; 5	—
PRIMARY Pain Disability Questionnaire	79.26; 80.65; 73; 78.2; 68; 79.2	—
PRIMARY PROMIS Instrument Questionnaire	53.82; 52.7; 49; 53; 47; 56	—
PRIMARY European Qualify of Life (EQ-5D) Questionnaire	3.82; 4.13; 3.6; 4.3; 3.4; 4.8	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03484403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.