N/A
Completed N=11
Epidural Lavage Study for Lumbar Stenosis
Source: ClinicalTrials.gov NCT03511053 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Visual Analogue Scale — 6.2; 5.0; 5.0; 0.8 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.