Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients

NCT ID: NCT01381224

Last Updated: 2013-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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

Conditions

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Low Back Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observation of biomechanical effects post injection

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryan P Conrad, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

D J Kennedy, M.D.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

Heather K Vincent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

Deepa Sunkari, M.D.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

Amanda N Seay, B.S.

Role: PRINCIPAL_INVESTIGATOR

UF Department of Orthopaedics and Rehabilitation

Locations

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Shands Rehabilitation Hospital

Gainesville, Florida, United States

Site Status

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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629-2010

Identifier Type: -

Identifier Source: org_study_id

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