Epidural Steroid Injection With Supplemental Oral Eplerenone for Low Back Pain: A Prospective, Double Blind Randomized Trial
Phase: PHASE4
Conditions: Degenerative Intervertebral Discs, Sciatic Radiculopathy, Low Back Pain
Sponsor: University of Cincinnati

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Study Title: Epidural Steroid Injection with Supplemental Oral 
Eplerenone for Low Back Pain: A Prospective, Double Blind 
Randomized Trial. 
Research Team: Timothy Burroughs MD, Jun-Ming Zhang MD, M.Sc., 
Judith A Strong PhD, Kushlaf Hani MD,  Denise Richardson RN 
Principal Investigator: Timothy Burroughs, MD 
Coordinator(s): Denise Richardson RN 
Sponsor: U.C. Department of Anesthesiology and College of Medicine 
(College of Medicine’s Research Innovation Seed Grant) 
IRB Protocol number:  2017-2713 
 
 

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1. Length of time for research 
a. data collection completion: two years 
b. data analysis and report writing/publication: two years 
 
2. Research Location(s):  
 
UCHealth Pain Medicine Center - chronic pain outpatient clinics associated with 
University of Cincinnati College of Medicine Department of Anesthesiology at West 
Chester and Midtown locations. 
 
 
3. Abstract/Brief Overview: 
 
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.  We 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, the 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. The primary outcome will be improvement in treatment 
outcome as measured by the Oswestry Low Back Pain Questionnaire, a validated 
research instrument that investigates both pain and functional outcomes. Subjects will 
be followed for one year.  Secondary outcomes include the clinical course, in particular, 
whether the patient requires additional injections or not as part of their routine clinical 
care. 
 
 
4. Purpose of Study:  
 
Lumbar epidural steroid injections are commonly used for the management of low back 
and lower extremity pain, including lumbar disc herniation causing radiculopathy. The 
variability of response to epidural steroid injections has resulted in questions regarding 
technique, disease diagnosis, and medications administered. Preclinical research 
suggests that the anti-inflammatory corticosteroids often used in epidural steroid 
injections have activity at the glucocorticoid receptor (GR), its primary target, but also 
some activity at the mineralocorticoid receptor (MR) )1,2. Activation of the MR, in many 
tissues, promotes the production of pro-inflammatory cytokines 3,4. Our primary 
hypothesis is that treatment of low back pain with corticosteroids is not maximally 
effective because the steroids used clinically activate the pro-inflammatory MR in 
addition to the drug’s primary target, the GR. By blocking the MR with the orally 

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administered steroid antagonist, eplerenone, pro-inflammatory effects of corticosteroid 
administration will be reduced, promoting the anti-inflammatory effect of GR activation. 
To test this hypothesis we propose the following specific aims: 
 
1. Recruit patients who meet study criteria and conduct a double-blind trial by 
providing eplerenone or placebo in conjunction with lumbar epidural steroid 
injection. 
2. Utilize the Oswestry Low Pain Questionnaire (version 2) prior to and following 
treatment up to one year to monitor treatment effectiveness. 
 
 
5. Background:   
Low back pain is a leading cause of disability and health care costs in the United States, 
and treatments are ineffective for many patients5,6. Lumbar epidural injections remain 
one of the most commonly performed procedures for treatment of lumbar 
radiculopathy7. Despite widespread use of epidurals, clinical effectiveness and cost 
effectiveness have been challenged. Multiple randomized control trials evaluating the 
efficacy of epidural injections for pain, resulted in conflicting conclusions 8. The 
variability of response has been attributed to approach, technique, indication, and 
medications used. Initially performed with local anesthetic alone, steroids were added to 
epidural injections in the 1950s and used regularly since then 9. While often used, the 
mechanism by which injected steroids provide reduction in pain from lumbar 
radiculopathy is still being elucidated and the cause for inconsistent results is unclear. 
 
Local inflammation in the region of the lumbar sensory ganglia plays a role in many 
forms of low back pain, including those forms involving pathology of the intervertebral 
discs 10,11. A common treatment for some forms of low back pain is local injection of 
corticosteroids. Randomized clinical trials of such treatments have often suggested that 
steroid injections are effective only in the short term12,13. The nominal target of anti-
inflammatory corticosteroid drugs is the glucocorticoid receptor (GR). However, recent 
in vitro studies show that many clinically used steroids (including those commonly used 
for back pain, e.g. 6-α methylprednisolone and triamcinolone) can also activate the 
mineralocorticoid receptor (MR) with similar potency 1,2. The MR was originally viewed 
only as the target of aldosterone, promoting sodium reabsorption in the kidney. 
However, this receptor has been detected in other cell types including peripheral 
sensory neurons14. In many tissues, MR activation is pro-inflammatory 3,4. Some pro-
inflammatory effects may be due to receptors in macrophages, where MR activation 
promotes production of pro-inflammatory cytokines and tissue destruction, while GR 
activation promotes tissue remodeling and wound repair 15. We hypothesize that adding 
an oral MR blocker, eplerenone, at the time of steroid epidural injections for low back 

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pain due to lumbar degenerative disc disease, will improve response to the injected 
corticosteroids. 
 
Eplerenone is chosen as a more specific MR blocker than its predecessor, 
spironolactone 16, avoiding side effects such as gynecomastia and sexual dysfunction. It 
is currently approved for use in the US as a therapy for high blood pressure and for 
heart failure. Its effectiveness in heart failure is thought to be due in part to anti-
inflammatory effects in cardiac tissue15. 
 
In preclinical models of back pain, several of which were developed in our 
laboratories17, we have observed that pain behaviors and abnormal sensory neuron 
hyper-excitability induced by the models are reduced by local application of clinically 
used corticosteroids. Consistent with our hypothesis, highly selective GR agonists are 
more effective than clinically used steroids that activate both GR and MR, and oral or 
local EPL can improve the effectiveness of the latter14,18. Although some highly GR-
selective steroids are in clinical use (e.g., fluticasone), they are used primarily for topical 
or asthma indications and are not formulated for epidural injection. It should also be 
noted that in preclinical back pain models the model itself may locally activate the MR14; 
if this occurs in patients then even a highly selective epidural glucocorticoid steroid 
might be more effective with added MR blockers. 
 
6. Study design:  
 
The Department of Anesthesia has two suburban pain clinics that will serve as sources 
for recruiting subjects, UC Health Pain Medicine Center (Midtown) and UC Health Pain 
Medicine Center (West Chester). In the past year, 675 unique patients with the 
diagnosis of lumbar degenerative disc disease were evaluated between the two clinics. 
Our target number for study enrollment is 40 subjects (20 per group). We are requesting 
authorization for 60 subjects, in order to allow for subjects who drop out.  Patients 
evaluated for degenerative disc disease are routinely given an epidural steroid injection 
as part of their treatment regimen. Often this is the preferred treatment; if there is no 
clear indication for surgical intervention, a more conservative approach is sought prior to 
considering surgery.  
 
Eplerenone and placebo pills with blinded labels will be provided by Investigational Drug 
Pharmacy.    We will use a block-stratified randomization schedule with blocks of sizes 
2 and 4.  The West Chester and Uptown locations will have separate randomization 
schedules.  Patients will be randomized to receive either eplerenone or placebo, which 
will be taken for 10 days starting two days after the epidural injection. This timing is 
based on the pharmacokinetic profile of eplerenone, and on the time window in which 
the steroid injection is usually expected to begin having an effect (requiring a minimum 

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of 72 hours, and up to a week, to take effect). Studies show that eplerenone is well 
absorbed orally with a variable half-life of 2.2-9.4 hours 19. The dose of eplerenone will 
be 50 mg PO daily. This is a commonly used starting dose for eplerenone’s FDA-
approved and indicated use in the treatment of hypertension and heart failure. 
Eplerenone is extensively metabolized with less than 5% excreted unchanged in the 
urine. Thus, renal dysfunction has little effect on eplerenone pharmacokinetics. 
However, patients with compromised renal function may be at greater risk for 
hyperkalemia when taking eplerenone.  For this reason, a blood sample will be obtained 
from each participant to verify inclusion criteria related to kidney function (see below) 
based on a basic metabolic panel performed the day of the procedure. Subjects with 
elevated potassium or creatinine will not be included in the study.  The blood sample will 
be obtained just prior to the epidural injection, at the clinical laboratories located within 
(West Chester site) or adjacent to (Midtown clinic) the participating pain clinics.  This will 
allow the results (metabolic panel including K+ and creatinine level) to be available by 
the following day.  In order to avoid having subjects make an additional trip to the clinic, 
subjects will receive their study medications via overnight delivery service, once their 
blood test results have been reviewed.  Alternatively, subjects who prefer may return to 
the clinic to pick up their medications.  A single take-home sheet of information about 
the study medication will be given to each patient along with the medication, to help 
reinforce these directions (included in IRB submission).  We anticipate that few subjects 
will be excluded on the basis of their blood test.  Such subjects will still receive the $35 
incentive payment for completing their first Oswestry questionnaire, however, their data 
will not be included in the study.  Patients will be offered access to their blood test 
results, and given the option of having their primary care physicians notified of any 
abnormal findings. 
 
Patients are normally seen for follow-up approximately one month after an epidural 
injection.  Subjects who are recommended to have a second epidural injection at this 
follow-up visit will receive a second dose of the same study medication they received 
after their first injection.  The same protocol will be followed: such subjects will have a 
repeat blood draw and re-confirmation of inclusion parameters prior to restarting the 
medication.  Subjects who become ineligible at the time of the second injection will not 
receive a second round of study medication, but will continue to complete 
questionnaires and their data will be retained for analysis. 
 
All patients will receive the same epidural steroid and approach (interlaminar injection of 
Kenalog (triamcinolone) and saline) as part of their standard care.  Triamcinolone has a 
substantial potency for the MR in addition to the GR; all of the steroids commonly used 
for epidural injections show some activity at the MR 2.  The procedures and drug are 
routinely used at the participating clinics for treatment of degenerative disc disorders. 
We will use the REDCap (Research Electronic Data Capture) system for secure web 
based capture of questionnaire data, which is required in order to protect the 

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confidentiality of the subjects’ data.  This is provided by the Center for Clinical and 
Translational Science and Training.  We already use this system for another project. 
7. Research data collection/study procedures: 
 
Patients meeting criteria 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. This instrument is 
commonly used for research and is well-validated 20.  It is completed by the patient and 
captures the functional effects of back pain on various activities, providing a more 
meaningful picture than a simple static pain rating. 
 
The patients 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.  The research nurse will contact the patients for additional 
follow-up at 3 months, 6 months, 1 year after their epidural injection (or after their 
second epidural injection if this is recommended).   
 
Follow-up contacts will be made via email, text message, or phone, based on the 
subject’s preference.  For patients opting to have a link to the Oswestry sent to their cell 
phones, the REDCap-Twillio integration platform will be used. The follow-up will be used 
to direct the patients to an online version of the Oswestry Questionnaire or a mailed in 
or telephone version, as per the subject’s preference.  Subjects will receive a $35 gift 
card for each completed follow-up, to improve the response rate. Patients will also be 
informed of potential eplerenone side effects, including but not limited to dizziness, 
fatigue, abdominal pain, and diarrhea. Patients will be instructed to discontinue the 
medications and contact the on-call physician should they experience an adverse 
reaction. Patients referred for a second injection will receive a second round of the 
same drug (eplerenone or placebo) to which they were first randomized.  Currently 
approximately 30% of the patients seen at the clinic receive a second injection. 
 
 
 
8. Specimen collection:  
 
Study participants will consent to providing a blood sample for performing a basic 
metabolic panel. Safety parameters related to kidney function will be confirmed prior to 
the start of the blinded medication.  Both participating clinics have immediate proximity 
to Lab Corp facilities where the samples will be collected and analyzed. One sample 
collection tube (approximately 5 mL) prior to each epidural steroid injection is all that will 
be required from each subject. 
 

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9. Potential Benefits:  
 
Anticipated contributions from the proposed research include an improved method for 
the treatment of radicular low back pain, a growing healthcare concern. Application of 
an existing medication to a different problem allows widespread accessibility and ease 
of further evaluation through multicenter trials. In addition, this study will provide a better 
understanding of the mechanism of steroid use in the treatment of low back pain, and 
provide an avenue for translation of the department’s basic science findings.   
 
 
10. Potential Risks, Discomforts, and inconveniences:  
 
Potential risks include those associated with, administration of the study drug, and 
collection of the blood sample. Based on study design, the epidural steroid lumbar 
injection procedure performed will be indicated by clinical criteria and is standard of 
care, so risks of these procedures are not related to participation in the study. 
Eplerenone is a highly selective aldosterone receptor antagonist significantly reducing 
progesterone and antiandrogen activity seen in other aldosterone antagonists, such as 
spironolactone. It is well absorbed and extensively metabolized to inactive 
metabolites19. Associated risks with the study medication are expected to be small; the 
primary warnings and precautions relate to hyperkalemia, as eplerenone is potassium 
sparing. A blood sample will be collected and a basic metabolic panel performed to 
ensure normal serum potassium level and normal creatinine level prior to the study. In 
the context of normal kidney function there is expected little risk of developing 
hyperkalemia. Phlebotomy is associated with a very small risk of infection, bleeding, 
hematoma, and pain. Subsequent follow up will be in the form of a questionnaire, 
expected to take a few minutes to complete. Patients will be compensated with a $35 
gift card at every subsequent follow up as a token of appreciation. 
 
Risks of adverse reactions were obtained from the FDA drug information sheet; 
however, note that some of these numbers were probably obtained from longer term 
use or higher doses than we propose: 
 
 
Hyperkalemia (3 – 4%) 
 
Diarrhea (1 – 2%) 
 
Abdominal pain (1%) 
 
Coughing (1 – 2%) 
 
Dizziness (1 – 3%) 
 
Fatigue (1 – 2%) 
 
Influenza-like symptoms (1 – 2%) 
 

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Criteria for having a subject stop the study medication early: any adverse reaction to the 
medication concerning enough to the subject to have them call the researchers, or any 
adverse reaction deemed possibly study related during follow-up phone calls that will be 
made to the subjects 4 – 7 days after starting the study medication.  Such subjects 
would continue to complete questionnaires and that data would be retained in the study.  
They would not receive a second round of study medication if referred for a second 
epidural steroid injection.  
 
Criteria for stopping the study early:  Any single instance of hospitalization or 
emergency room visit deemed likely related to the study medication, or two instances of 
subjects discontinuing the study medication early due to reported side effects requiring 
a doctor visit deemed likely related to the study medication 
 
11. Data Safety monitoring plan and/or DSMB:  
Patients recruited to participate will undergo the clinically indicated lumbar epidural 
steroid injection as part of their treatment regimen, considered standard of care. 
Additionally, they will concurrently receive the study drug or placebo for ten days. 
Patients who have met all inclusion criteria, including a basic metabolic panel with 
potassium and creatinine within normal limits, are expected to have low risk of adverse 
effects from the study drug - eplerenone. However, participants will be informed of 
potential side effects, including but not limited to dizziness, fatigue, abdominal pain, and 
diarrhea, and instructed to call study physician to discuss evaluation and/or 
discontinuation.  
An interim analysis will be conducted halfway through the study (after 20 subjects are 
enrolled) to ensure there are no unexpected adverse responses to eplerenone.  Dr. 
William Hurford, a department physician not involved with the study, will review 
subjects’ records for safety issues on an ongoing basis.  
 
12. Data Analysis:  
The primary analysis will be to compare the change (difference score) in the Oswestry 
Disability Index between the placebo and eplerenone groups at each time point.  Scores 
on this instrument range from 0 to 100%.  With 20 subjects per group, a difference of 9 
points in score can be detected with 80% power and α = 5%, assuming a standard 
deviation of 10.  This value of standard deviation has been observed in similar studies 
20.  Some studies have considered a difference of 4 points to be clinically significant 
while others have used higher values, up to 15 (the value used by the FDA in evaluating 
one back pain procedure).  Average differences of 15 have been reported in studies of 
sciatica and chronic back pain20.  Thus although the sample size is small it should be 
large enough to detect large or moderately sized clinically significant differences 

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between the groups.  The Mann-Whitney test will be used to evaluate the significance of 
differences between the two groups, as the Oswestry is an ordinal scale.   
 
Primary outcome measure:  The change from the pre-injection Oswestry Disability 
Index scores for low back pain and disability at the selected time points. 
 
Secondary outcome measures: We will also classify the clinical course following the 
first steroid injection, grouping patients into 3 groups as normally done by the 
participating clinics:  1) Pain relief deemed adequate and no further treatment 
recommended; 2) partial pain relief obtained and a second injection recommended (this 
usually occurs about 4-6 weeks after the first); 3) no pain relief obtained and alternative 
treatments pursued.  Additional demographic data routinely collected for clinical 
purposes will also be analyzed (e.g. age, sex, weight/BMI, subtype of disc 
degeneration, duration and history of low back pain symptoms).  As this is a small pilot 
study we do not anticipate having enough subjects to do a detailed analysis of 
interactions between the treatment and these other variables, but we will determine 
whether the two groups differ from one another on these secondary variables despite 
randomization. 
 
13. Data storage and confidentiality  
 
The signed consent forms will be stored in locked cabinets at the 2 participating clinics 
accessible only to the research nurse.  The research nurse who consents the patients 
and administers the inventories, and the team member who mails out the medications 
after blood test results are obtained, will be the only members of the research team 
other than clinical providers who have access to the names of the patients. Original 
paper copies of the Brief Pain Inventories will be stored in the locked research 
laboratory in a locked cabinet accessible only to members of the research team. The 
names of the subjects will only be on the consent forms, and all other data including the 
inventories will be identified only by subject code numbers.   The research nurse will 
enter the inventory scores and demographic data into a project database that will be 
stored in the Redcap server.  The database will be designed with dropdown entries so 
that invalid values for the pain ratings cannot be entered.  The Redcap data is 
encrypted and password protected so that only study members have access to it.  A 
different researcher will verify the accuracy of data entry in a random 15% subset of the 
brief pain inventories that are manually entered.  One member of the research team has 
already completed Redcap training.  The Redcap project design has been completed. 
The deidentified data extracted from Redcap, and computer files generated from 
analysis of the data, will be stored on the research server.  This server is password 
protected so that only members of the Co-investigator’s laboratory can have access, 
and the directory containing study data will be further restricted so only the researchers 

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directly involved in the study have access.  The server contents are automatically 
backed up several times per day and retained off-site for 30 days.  
Paper copies of subject surveys will be destroyed when the study has been completed 
and the IRB protocol has been closed.  
 
 
14. Study Population  
 
Inclusion criteria: We are requesting authorization to recruit up to 60 subjects to allow 
for dropouts, with a goal of recruiting 40 subjects (20 per group). Subject must meet the 
following inclusion criteria: 
 
 
Adult patients of either sex, age 18 to 65  
 
Scheduled for lumbar epidural steroid injection as part of routine clinical care 
 
Have a diagnosis of lumbar degenerative disc disease demonstrated on either 
lumbar X-Ray or lumbar MRI.  
 
Have unilateral radicular symptoms or EMG 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, which is known to be 
a sensitive, but not specific test for nerve root irritation. 
 
Exclusion criteria: Excluded from the study will be patients with medical 
contraindications, including specifically those related to use of eplerenone: 
  
 
Unable to complete questionnaires or give informed consent in English 
 
Unavailable for follow-up contacts to complete questionnaires 
 
Renal impairment (estimated GFR <50 mL/min or serum creatinine >1.8mg/dL) 
on metabolic panel obtained just prior to epidural injections. 
 
Elevated serum potassium (>5.5 mEq/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, a class of antiviral drugs widely used to treat 
HIV/AIDS and Hepatitis C (included in list below and in the prescreening document to 
be used by the study nurse).  This exclusion is based on the unpredictable metabolism 
of steroid observed with concurrent administration and such patients are also excluded 
from receiving epidural injections. 
 
Taking strong CYP3A4 inhibitors (included in detailed list given below and in the 
prescreening document to be used by the study nurse) 

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 
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. 
 
Patients receiving epidural steroid injections are already required to sign a 
pregnancy waiver, because the steroid is FDA pregnancy category C and involves 
fluoroscopy exposure.  Patients with childbearing potential will be given a urine 
pregnancy test.  Patients without a pregnancy waiver or negative urine test will also be 
excluded from the study.   Eplerenone is a category B medication.  
 
By limiting the study to patients with pain due to degenerative disc disease we aim to 
have a more defined population; different types of low back pain may have different 
etiologies, different degrees of local inflammation, and different sensitivity to epidural 
steroid.  Clinical trials of epidural steroids in which multiple types of patients are lumped 
together have been criticized as difficult to interpret 12,13.  
 
Drugs that if being taken by the patient will exclude them from the study (both generic 
and brand names are given): 
Aldactone 
amiloride 
Aptivus 
atazanavir 
Biaxin 
Bunavail 
clarithromycin 
Crixivan 
Crixivan 
darunavir 
darunavir/cobicistat 
Dyrenium 
Evotaz 
Fortovase 
fosamprenavir 
indinavir 
indinavir 
Invirase 
Invirase 
itraconazole 
Kaletra 
Ketek 
Ketek 

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ketoconazole 
Lexiva 
lopinavir/ritonavir 
Midamor 
nefazodone 
nelfinavir 
nelfinavir 
Nizoral 
Norvir 
Norvir 
Pak 
Potassium supplements 
Prezcobix 
Prezista 
Reyataz 
ritonavir 
ritonavir 
saquinavir 
saquinavir 
Serzone 
spironolactone 
Sporanox 
suboxone 
Suboxone 
Tao 
tazanavir/cobicistat 
telithromycin 
tipranavir 
triamterene 
troleandomycin 
Viracept 
Viracept 
Zubsolv 
  
Examples of salt substitutes containing potassium that patient cannot be using  
 
Morton Salt Substitute 
NoSalt 
Nu-Salt 
Morton Lite Salt 
(Herb blends such as Mrs. Dash are OK, not based on potassium substitution.)  
 

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15. Consenting process and plan  
 
In normal practice, patients are evaluated for low back pain. The formulation of a 
treatment plan may involve administration of a lumbar epidural steroid injection. 
Providers at the aforementioned clinics have agreed to allow recruitment of patients and 
will identify eligible subjects during the course of clinic visits.   A one page summary of 
the study for providers will be made available at the clinics.  Study personnel will also 
review the clinic schedule to identify additional potential subjects who have been 
scheduled to have an epidural steroid injection.  The study nurse will contact these 
potential subjects by phone to inform them of the study.  We have applied for an IRB 
waiver to do a preliminary research screening in the medical record, to avoid 
approaching potential subjects outside the age range or excluded conditions.  The 
research will not alter the standard of care related to low back pain.  
 
A one page invitation to participate in the study will be available for patients referred for 
epidural steroid injections.  If patients are interested in participating, the research nurse 
will contact them to obtain consent, review risks and benefits, administer the pain 
inventory assessment. This process will be initiated during the initial evaluation 
appointment, or by phone (during the interval between evaluation/referral and the actual 
epidural injection),  and consenting will be completed at the time of procedure and blood 
draw.  A prescreening document will be used to note the information obtained from 
patients approached in the study, to document the reasons for screening failures.  
These documents will be stored with the consent documents. 
 
16. Compensation:  
 
Participants will be compensated with a $35 gift card for every questionnaire completed 
– at 4 weeks, 3 months, 6 months, and one year following.  Patients who are referred 
for a second epidural injection (typically 4 – 6 weeks after the first) will complete an 
additional questionnaire at the time of the second injection and receive an additional 
$35 gift card. Payments will be made using the Greenphire system. 
 
 
17. Subject costs:  
 
There is no additional cost expected from the subjects. No extra clinic visits outside the 
standard of care are required. 
 
 

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