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Completed

NCT Number: NCT01381224

Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shands Rehabilitation Hospital, Gainesville, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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