Eplerenone as a Supplement to Epidural Steroid Injections
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain, Neurology |
| Therapuetic Areas: | Musculoskeletal, Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/20/2018 |
| Start Date: | November 8, 2017 |
| End Date: | June 2019 |
| Contact: | Timothy J Burroughs, MD |
| Email: | burrout@ucmail.uc.edu |
| Phone: | 513-375-8876 |
Epidural Steroid Injection With Supplemental Oral Eplerenone for Low Back Pain: A Prospective, Double Blind Randomized Trial
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.
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.
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.
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.
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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials