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Eplerenone as a Supplement to Epidural Steroid Injections

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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 at participating clinics 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03418649
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Shuchita Garg, MD
Principal Investigator Affiliation University of Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Degenerative Intervertebral Discs, Sciatic Radiculopathy, Low Back Pain
Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental

Eplerenone 50 Mg Tab

Placebo Comparator: Control

Placebo Oral Tablet

Interventions

Drug: - Eplerenone 50 Mg Tab

50 mg PO per day for 10 days

Drug: - Placebo Oral Tablet

PO once daily for 10 days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cincinnati, Ohio

Status

Address

UC Health Pain Medicine Center in Clifton

Cincinnati, Ohio, 45267

Site Contact

Shuchita Garg, MD

[email protected]

513-475-8282

West Chester, Ohio

Status

Address

UC Health Pain Medicine Center in West Chester

West Chester, Ohio, 45069

Site Contact

Shuchita Garg, MD

[email protected]

513-475-8282

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