NCT03418649

Eplerenone as a Supplement to Epidural Steroid Injections

Epidural Steroid Injection With Supplemental Oral Eplerenone for Low Back Pain: A Prospective, Double Blind Randomized Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 in the study prior to their first epidural steroid injection. If they consent, they will complete the Oswestry Low Back Pain Questionnaire (version 2) just prior to their first injection which captures the functional effects of back pain on various activities, providing a more meaningful picture than a simple static pain rating. The subjects will complete the Oswestry Low Back Pain Questionnaire again four weeks after their first injection, a time point at which patients routinely have a follow-up visit. Patients referred for a second injection at this time will complete an additional Oswestry just prior to that injection. Subjects will be asked to complete additional Oswestry Low Back Pain Questionnaires at 3 months, 6 months, 1 year after their epidural injection (or after their second epidural injection if this is recommended). Prior to receiving study medication (eplerenone or placebo), subjects will provide a blood sample to examine their creatinine and potassium levels, to ensure there are no contraindications to taking eplerenone. C reactive protein levels will also be measured just prior to epidural steroid injections to determine whether this can help predict the response. In addition to the pain questionnaires, data will be collected from the subjects' medical charts regarding basic clinical demographics and clinical outcome of the epidural steroid injection.

Conditions

• Degenerative Intervertebral Discs
• Sciatic Radiculopathy
• Low Back Pain

Interventions

Type	Name	Description
DRUG	Eplerenone 50 Mg Tab	50 mg PO per day for 10 days
DRUG	Placebo Oral Tablet	PO once daily for 10 days

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2018-02-01
• Last updated: 2023-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study