Eplerenone as a Supplement to Epidural Steroid Injections

Sponsor

University of Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT03418649

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Intervertebral Discs Sciatic Radiculopathy Low Back Pain	Drug: Eplerenone 50 Mg Tab Drug: Placebo Oral Tablet	Phase 4

Detailed Description

Patients with degenerative disc disease, who are recommended to have an epidural steroid injection 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind placebo controlled. Equal numbers of subjects receive 10 day course of eplerenone or placebo following their clinically indicated epidural steroid injectionDouble blind placebo controlled. Equal numbers of subjects receive 10 day course of eplerenone or placebo following their clinically indicated epidural steroid injection

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Drug or look-alike placebo dispensed according to a randomization schedule.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Eplerenone 50 Mg Tab	Drug: Eplerenone 50 Mg Tab 50 mg PO per day for 10 days Other Names: Inspra
Placebo Comparator: Control Placebo Oral Tablet	Drug: Placebo Oral Tablet PO once daily for 10 days Other Names: placebo for eplerenone

Arm

Intervention/Treatment

Experimental: Experimental

Eplerenone 50 Mg Tab

Drug: Eplerenone 50 Mg Tab

50 mg PO per day for 10 days

Other Names:

Inspra

Placebo Comparator: Control

Placebo Oral Tablet

Drug: Placebo Oral Tablet

PO once daily for 10 days

Other Names:

placebo for eplerenone

Outcome Measures

Primary Outcome Measures

change in Oswestry Low Back Pain Disability Questionnaire at 12 months [Difference between score prior to and 12 months after epidural steroid injection]
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.

Secondary Outcome Measures

epidural steroid injection clinical outcome [evaluated one month after injection as part of standard clinical care]
scored as 1 adequate pain relief, no further treatment recommended; 2, partial relief, second injection recommended; 3 little pain relief, alternative treatment recommended
change in Oswestry Low Back Pain Disability Questionnaire at 4 weeks [Difference between score prior to and 4 weeks after epidural steroid injection]
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
change in Oswestry Low Back Pain Disability Questionnaire at 3 months [Difference between score prior to and 3 months after epidural steroid injection]
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.
change in Oswestry Low Back Pain Disability Questionnaire at 6 months [Difference between score prior to and 6 months after epidural steroid injection]
back pain disability score ranging from 0 (no disability or pain) to 100% (maximum pain and disability); based on sum of responses to 10 questions each with responses ranging from 0 (no pain/disability) to 5 (maximum pain/disability) expressed as percentage of maximum score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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