Status:
WITHDRAWN
Eplerenone as a Supplement to Epidural Steroid Injections
Lead Sponsor:
University of Cincinnati
Conditions:
Degenerative Intervertebral Discs
Sciatic Radiculopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Low back pain is a leading cause of disability and health care costs in the United States, and treatments are ineffective for many patients. Epidural steroid injections are a common treatment, but the...
Detailed Description
Patients with degenerative disc disease, who are recommended to have an epidural steroid injection at the participating clinics, as part of their routine clinical care, will be invited to participate ...
Eligibility Criteria
Inclusion
- diagnosis of lumbar degenerative disc disease demonstrated on either lumbar X-Ray or lumbar MRI.
- radicular symptoms or electromyograph consistent with radiculopathy and exam findings corresponding to this diagnosis
- Scheduled for lumbar epidural steroid injection at participating clinics as part of routine clinical care
- Negative pregnancy test, if of childbearing potential
Exclusion
- Unable to complete questionnaires or give informed consent in English
- Unavailable for follow-up contacts to complete questionnaires
- Renal impairment (estimated glomerular filtration rate \<50 mL/min or serum creatinine \>1.8mg/dL) on metabolic panel obtained just prior to epidural injections.
- Elevated serum potassium (\>5.5 milliequivalents/L) on metabolic panel obtained just prior to epidural injections.
- Have undergone previous lumbar surgery within the past year.
- Treated with lumbar epidural steroid injection within the past 3 months at the time of consent.
- Diabetic
- Systolic blood pressure reading less than 100 mm Hg at most recent pain clinic visit.
- Prescribed protease inhibitors.
- Taking strong CYP3A4 inhibitors
- Taking potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene) or using salt substitutes that contain potassium (examples given below and in the prescreening document to be used by the study nurse).
- Lactating.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03418649
Start Date
June 1 2023
End Date
June 1 2026
Last Update
March 17 2023
Active Locations (2)
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1
UC Health Pain Medicine Center in Clifton
Cincinnati, Ohio, United States, 45267
2
UC Health Pain Medicine Center in West Chester
West Chester, Ohio, United States, 45069