Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

Completed

• Conditions: Low Back Pain
• Interventions: Other: Observation of biomechanical effects post injection

• Registration Number: NCT01381224
• Lead Sponsor: University of Florida

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation of biomechanical effects post injection	Observation 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.

Primary Outcome Measures

Name	Time	Method
Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection	Immediately following injection	We 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 Outcome Measures

Name	Time	Method
Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection	Two weeks following injection	We 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 reduction	Two weeks following injection	We 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

Trial Locations

Locations (2)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States

Shands Rehabilitation Hospital; 🇺🇸 Gainesville, Florida, United States