CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Lumbar back brace +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03484403
NCT03484403N/ACompleted

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

Dallas VA Medical Center·interventional·Posted Mar 30, 2018·Updated Jan 8, 2024

In Brief

A clinical study evaluating Lumbar back brace and Back school for Degenerative Disc Disease and 2 related conditions. Completed, enrolled 61 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2018
Enrollment StartDec 14, 2015
Primary CompletionSep 10, 2019
Study CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.3 years ago

Interventions

Lumbar back braceother

A brace that supports the lumbar region of the spine.

Back schoolbehavioral

Back school consists of patient education physical therapy exercise instruction.