Epidural Lavage Study for Lumbar Stenosis

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

The purpose of this research is to find out if there are inflammatory biomarkers (also known as biological markers) in epidural space that can predict response to an epidural steroid injection. This study will also be evaluating whether the results of an EMG study (also known as electromyography) can predict the response to an epidural steroid injection.

Key facts

Study ID

NCT03511053

Run by

Dallas VA Medical Center

People needed

11

Starts

2017-12-19

Expected to finish

2018-07-26

Last updated by the study team

2021-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mild-severe lumbar central canal stenosis identified by MRI or CT scan
• Symptoms:
• Lower extremety symptoms consistent with neurogenic claudication
• Pain, weakness and/or numbness triggered by standing or walking, and relieved by sitting
• Must be able to read English and complete assessment instruments

You may not qualify if…

• Cognitive impairment that renders the patient unable to give informed consent or provide accurate data
• Clinical co-morbidities that could interfere with the collection of data concerning pain and function
• Severe vascular, pulmonary, or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months)
• Spinal instability requiring surgical fusion
• Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis
• Metastatic cancer
• Excessive alcohol consumption or evidence of non-prescribed or illegal drug use
• Pregnancy
• Concordant pain with internal rotation of the hip (or known hip joint pathology)
• Active local or systemic infection
• Abnormal coagulation
• Allergy to local anesthetic, steroid, or contrast
• Previous lumbar spine surgery
• Prisoners
• Epidural steroid injection within previous 6 months
• Rheumatological disorders such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis

Where it is running

• Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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