Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients
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ClinicalTrials.gov Identifier: NCT01381224 |
Recruitment Status
:
Completed
First Posted
: June 27, 2011
Last Update Posted
: April 22, 2013
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Condition or disease | Intervention/treatment |
---|---|
Low Back Pain | Other: Observation of biomechanical effects post injection |
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 |

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.
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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
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- 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
- 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
- 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

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381224
United States, Florida | |
Shands Rehabilitation Hospital | |
Gainesville, Florida, United States, 32607 | |
UF&Shands Orthopaedics and Sports Medicine Institute | |
Gainesville, Florida, United States, 32607 |
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 |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT01381224 History of Changes |
Other Study ID Numbers: |
629-2010 |
First Posted: | June 27, 2011 Key Record Dates |
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 |