Eplerenone as a Supplement to Epidural Steroid Injections

• Status: Suspended
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 their efficacy has been questioned and for many patients they do not provide complete relief. The investigators hypothesize, based on preclinical studies, that lack of complete efficacy may be due to the fact that clinically used steroids activate not only the intended drug target, the glucocorticoid receptor, but also the pro-inflammatory mineralocorticoid receptor. To test this hypothesis, this pilot study will recruit patients scheduled for lumbar epidural steroid injections for degenerative disc disease, and randomize them to receive a concurrent treatment with oral eplerenone (a clinically approved antagonist of the mineralocorticoid receptor) or placebo for 10 days starting just after the epidural injection. At several time points during the following year, subjects will answer the Oswestry Low Back Pain Questionnaire, to report on both pain and functional outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Eplerenone; Spironolactone

Criteria

Inclusion Criteria:

• 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 as part of routine clinical care

• Negative pregnancy test, if of childbearing potential

Exclusion Criteria:

• 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.

• Treated with oral steroids or injectable steroid within the past year.

• Diabetic

• Systolic blood pressure reading less than 100 mm Hg at most recent 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.