Clinical trial NCT01381224: Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients
Official title: Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: low back pain
lumbar
injection
lumbar pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis

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.

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 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

Primary outcomes:
measure: Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection
timeFrame: Immediately following injection
Secondary outcomes:
measure: Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection
timeFrame: Two weeks following injection
measure: Determine the relationship between biomechanical status before injection and short-term pain reduction
timeFrame: Two weeks following injection
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Rehabilitation Hospital
state: Florida
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: UF Department of Orthopaedics and Rehabilitation
name: Bryan P Conrad, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UF Department of Orthopaedics and Rehabilitation
name: D J Kennedy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UF Department of Orthopaedics and Rehabilitation
name: Heather K Vincent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UF Department of Orthopaedics and Rehabilitation
name: Deepa Sunkari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UF Department of Orthopaedics and Rehabilitation
name: Amanda N Seay, B.S.
role: PRINCIPAL_INVESTIGATOR
References: