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Eplerenone as a Supplement to Epidural Steroid Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418649
Recruitment Status : Suspended (Unable to recruit during COVID-19 epidemic restrictions on associated clinical practice)
First Posted : February 1, 2018
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Harsh Sachdeva, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE February 1, 2018
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE November 8, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
change in Oswestry Low Back Pain Disability Questionnaire at 12 months [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • epidural steroid injection clinical outcome [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eplerenone as a Supplement to Epidural Steroid Injections
Official Title  ICMJE Epidural Steroid Injection With Supplemental Oral Eplerenone for Low Back Pain: A Prospective, Double Blind Randomized Trial
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.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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 injection
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Drug or look-alike placebo dispensed according to a randomization schedule.
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Intervertebral Discs
  • Sciatic Radiculopathy
  • Low Back Pain
Intervention  ICMJE
  • Drug: Eplerenone 50 Mg Tab
    50 mg PO per day for 10 days
    Other Name: Inspra
  • Drug: Placebo Oral Tablet
    PO once daily for 10 days
    Other Name: placebo for eplerenone
Study Arms  ICMJE
  • Experimental: Experimental
    Eplerenone 50 Mg Tab
    Intervention: Drug: Eplerenone 50 Mg Tab
  • Placebo Comparator: Control
    Placebo Oral Tablet
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of lumbar degenerative disc disease demonstrated on either lumbar X-Ray or lumbar MRI.
  • unilateral radicular symptoms or electromyograph consistent with radiculopathy and exam findings corresponding to this diagnosis: with symptoms reflecting a dermatomal distribution of pain and positive response to straight leg raise test
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418649
Other Study ID Numbers  ICMJE 2017-2713
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Harsh Sachdeva, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy J Burroughs, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP