Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

Low Back Pain Clinical Trial

Official title:

Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381224
• Other study ID #: 629-2010
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: April 18, 2013
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Shands Rehabilitation Hospital	Gainesville	Florida
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No