Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

NCT01381224 | Completed

• 1 other identifier: 629-2010
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

low back pain; lumbar; injection; lumbar pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection

  Two weeks following injection

• Determine the relationship between biomechanical status before injection and short-term pain reduction

  Two weeks following injection

Study Arms (1)

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

Interventions

Observation of biomechanical effects post injection OTHER

Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection

Observation of biomechanical effects post injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis

You may qualify if:

• diagnosis of lumbar spine stenosis
• receiving lumbar epidural injection
• age 18-90 years
• BMI \<35kg/m2
• walking unaided

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Shands Rehabilitation Hospital

Gainesville, Florida, 32607, United States

Location

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

US (2)