Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Low Back Pain	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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	30 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain
Study Start Date :	January 2011
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection [ Time Frame: 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 :

1. Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection [ Time Frame: 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
2. Determine the relationship between biomechanical status before injection and short-term pain reduction [ Time Frame: 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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT01381224 History of Changes
Other Study ID Numbers:	629-2010
First Posted:	June 27, 2011
Last Update Posted:	April 22, 2013
Last Verified:	April 2013

Keywords provided by University of Florida:

low back pain; lumbar; injection; lumbar pain

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms