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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Eplerenone 50 Mg Tab |
|
| Control | Placebo Comparator | Placebo Oral Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone 50 Mg Tab | Drug | 50 mg PO per day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Oswestry Low Back Pain Disability Questionnaire at 12 months | 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. | Difference between score prior to and 12 months after epidural steroid injection |
| Measure | Description | Time Frame |
|---|---|---|
| epidural steroid injection clinical outcome | scored as 1 adequate pain relief, no further treatment recommended; 2, partial relief, second injection recommended; 3 little pain relief, alternative treatment recommended | evaluated one month after injection as part of standard clinical care |
| change in Oswestry Low Back Pain Disability Questionnaire at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuchita Garg, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Health Pain Medicine Center in Clifton | Cincinnati | Ohio | 45267 | United States | ||
| UC Health Pain Medicine Center in West Chester |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2017 | Jan 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2018 | Jan 24, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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Double blind placebo controlled. Equal numbers of subjects receive 10 day course of eplerenone or placebo following their clinically indicated epidural steroid injection
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Drug or look-alike placebo dispensed according to a randomization schedule.
| Placebo Oral Tablet | Drug | PO once daily for 10 days |
|
|
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. |
| Difference between score prior to and 4 weeks after epidural steroid injection |
| change in Oswestry Low Back Pain Disability Questionnaire at 3 months | 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. | Difference between score prior to and 3 months after epidural steroid injection |
| change in Oswestry Low Back Pain Disability Questionnaire at 6 months | 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. | Difference between score prior to and 6 months after epidural steroid injection |
| West Chester |
| Ohio |
| 45069 |
| United States |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |