N/A N=11 Treatment

Epidural Lavage Study for Lumbar Stenosis

Lumbar Spinal Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT03511053 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Visual Analogue Scale — 6.2; 5.0; 5.0; 0.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Epidural Steroid Injection with Lavage (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dallas VA Medical Center
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analogue Scale	6.2; 5.0; 5.0; 0.8; 1	—
PRIMARY Swiss Spinal Stenosis Questionnaire	64.1; 53.2; 53.5; 11.7; 10.3	—
PRIMARY Pain Disability Questionnaire	77.5; 53.3; 64.3; 27.3; 16.2	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03511053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.