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Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01381224
First received: June 22, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention
Low Back Pain
Other: Observation of biomechanical effects post injection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection [ Time Frame: Immediately following injection ] [ Designated as safety issue: No ]
    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:
  • Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection [ Time Frame: Two weeks following injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381224

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01381224     History of Changes
Other Study ID Numbers: 629-2010
Study First Received: June 22, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
low back pain
lumbar
injection
lumbar pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014