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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Observation of biomechanical effects post injection

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • UF&Shands Orthopaedics and Sports Medicine Institute
    • Gainesville, Florida, United States, 32607
      • Shands Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the immediate biomechanical effect in patients that receive a lumbar epidural 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	Immediately following injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the short-term biomechanical effect in patients that receive a lumbar epidural 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	Two weeks following injection
Determine the relationship between biomechanical status before injection and short-term pain reduction	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	Two weeks following injection

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Bryan P Conrad, Ph.D., UF Department of Orthopaedics and Rehabilitation; Principal Investigator: D J Kennedy, M.D., UF Department of Orthopaedics and Rehabilitation; Principal Investigator: Heather K Vincent, Ph.D., UF Department of Orthopaedics and Rehabilitation; Principal Investigator: Deepa Sunkari, M.D., UF Department of Orthopaedics and Rehabilitation; Principal Investigator: Amanda N Seay, B.S., UF Department of Orthopaedics and Rehabilitation

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: low back pain; lumbar pain; lumbar; injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 629-2010