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Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01381224
Enrollment
30
Registered
2011-06-27
Start date
2011-01-31
Completion date
2012-10-31
Last updated
2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, lumbar, injection, lumbar pain

Brief summary

The purpose of this project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance.

Detailed description

The purpose of this project is to determine the effect of lumbar injections on select biomechanics parameters; walking pattern, lumbar flexibility and balance. The surveys will help assess the patient's sense of functional ability and feeling of wellness compared with low back pain scores. The long terms goals of this project will be to elucidate the mechanism of action of injections and to improve identification of patients that are likely to benefit from injection therapy

Interventions

OTHERObservation of biomechanical effects post injection

Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of lumbar spine stenosis * receiving lumbar epidural injection * age 18-90 years * BMI \<35kg/m2 * walking unaided

Exclusion criteria

* age \<18 or \>90 years * BMI \>35 kg/m2 * severely impaired intellectual capacity * medications that could impact balance * dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol

Design outcomes

Primary

MeasureTime frameDescription
Determine the immediate biomechanical effect in patients that receive a lumbar epidural injectionImmediately following injectionWe hypothesize that patients will demonstrate increased gait velocity, increased step length, decreased asymmetry and increased lumbar ROM immediately after injection compared to pre-injection

Secondary

MeasureTime frameDescription
Determine the short-term biomechanical effect in patients that receive a lumbar epidural injectionTwo weeks following injectionWe hypothesize that patients will demonstrate increased gait velocity, increased step length, decreased asymmetry and increased lumbar ROM 2 weeks after injection compared with pre- and post-injection time points
Determine the relationship between biomechanical status before injection and short-term pain reductionTwo weeks following injectionWe hypothesize that those patients with moderate biomechanical limitation before injection (e.g., higher gait velocity, higher step length, lower asymmetry, and greater lumbar ROM) will have greater positive biomechanical response than patients who demonstrate severe biomechanical limitation pre-injection. This response to the injection will be measured by the changes in gait and lumbar spine range of motion and pain symptoms with these activities at 2 weeks after the injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026