Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial
Phase: PHASE4
Conditions: Pain, Radiating
Sponsor: OrthoCarolina Research Institute, Inc.

 
 
 
 
 
 
 
 
 
 
 
 
 
Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical 
Radicular Pain (SPIES): a Randomized, Controlled Trial  
 
 
 
 
NCT02226159  
 
 
Document Date:  April 17, 2015

Title: Surgery Prevention by Transforaminal Injection of Epidural Steroids for 
Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial 
Protocol Version #4  
Date: 4/17/15 
 
Background and Rationale 
Cervical radicular pain is a common cause of disability and pain in the upper extremity 
and neck with an annual incidence of 83.2/100,000 (1).  The initial treatment is 
conservative and includes relative rest, use of anti-inflammatory and analgesic 
medication, as well as physical therapy and home exercise.  For patients who have 
persistent and significant symptoms, interventional pain management and surgical 
management are considered.  Cervical epidural injections are the mainstay of the 
interventional, non-surgical modalities.  They can be considered to provide short and 
long-term relief when disc herniation, foraminal stenosis or central canal stenosis 
pathology is identified.   
 
Cervical epidural injections can be performed by two different approaches, 
transforaminal and interlaminar. Transforaminal epidural injections allow delivery of 
medication to the ventral epidural space, while the interlaminar approach reaches the 
ventral epidural space in only 28% of injections (2-4).  The results of cervical epidural 
injections remain controversial and their efficacy in decreasing the need for surgery in 
patients who would otherwise be operative candidates has not been thoroughly 
investigated.  Studies have been limited by small sample sizes, lack of control groups, 
and lack of randomization.  Kolstad et al reported that 23% (5/21) of patients waiting for 
cervical disc surgery cancelled surgery when assessed at four months after having a 
series of two cervical epidural injections (6).  Lin et al reported that 63% (44/70) of 
patients who were deemed to be surgical candidates were able to avoid surgery with an 
average of 13-month follow up (7).  Lee et al reported that over 80% of 98 patients 
evaluated with cervical radiculopathy were able to avoid surgery with a 2-year follow-up 
(8).  Anderberg et al reported that there was no short-term difference in symptoms of 
cervical radiculopathy between patients who received transforaminal injections of 
steroid with local anesthetic versus saline with local anesthetic. However, this study did 
not evaluate whether the injections were successful in the patients avoiding surgery 
(11). 
 
In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that 
steroid injections obviated the need for surgery in patients with lumbar radiculopathy. 
Moreover, Reiw et al showed that steroid combined with local anesthetic was more 
effective than local anesthetic alone in a prospective, randomized, controlled, double-
blinded study (9).  Riew et al later studied the efficacy of cervical transforaminal epidural 
injections in the same fashion, but the findings were not statistically significant (p<0.35) 
and not published (10).   
 
We are not aware of any published prospective, randomized, controlled, double-blinded 
studies demonstrating the efficacy of cervical transforaminal epidural steroid injections.  
However, the North American Spine Society (NASS) Review and Recommendation 
Statement states that based on the literature and expert opinion, a minimum of one or 

two cervical epidural steroid injections would be very appropriate in the treatment of a 
specific episode of cervical radicular pain. This literature also suggests that a maximum 
of four injections can be used within six months, assuming there was a positive 
response and improvement seen with the previous injections. 
 
Study Design 
This is a randomized, double-blinded clinical trial. The total enrollment goal is 60 
patients (30 per treatment group) 
 
 
Objective 
The purpose of this study is to determine the effectiveness of cervical transforaminal 
epidural steroid injections in decreasing the need for an operation in patients with 
cervical radicular pain, otherwise considered to be operative candidates. 
 
Treatment Groups: 
Patients will be randomized in a 1:1 fashion to one of the following treatment arms: 
1. Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline 
2. Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of 
Dexamethasone (10 mg/cc) 
 
Primary/Secondary Outcome Variables 
 
Primary Outcome Variables: The primary outcome variable is the avoidance of 
surgery. Treatment success is defined as the avoidance of surgery, while treatment 
failure is defined as having surgery due to failure of the injection treatment to alleviate 
pain and improve function over the 12 months they are being followed for purposes of 
this study. 
 
Secondary Outcome Variables: Secondary outcome variables include: 
 Decreased disability as measured by the validated outcome measure tool, the 
Neck Disability Index (NDI).  
 Decreased neck pain and radicular pain as measured by a numerical pain rating, 
Verbal Numeric Pain Score with 0 being no pain and 10 being the worst pain 
imaginable 
 Patient Satisfaction as measured by a numerical pain rating, Verbal Numeric 
Pain Score with 0 being completely unsatisfied and 100 completely satisfied 
 
Patient Selection and Treatment Plan 
Patients deemed to be surgical candidates for the treatment of cervical radicular pain at 
OrthoCarolina, PA will be screened for eligibility and asked to participate in the study.  
Potential subjects will meet with a research coordinator to discuss the details of the 
study.  Those who choose to participate will be consented accordingly. 

 
Inclusion Criteria:  
1. Subjects who have cervical radicular pain without significant neurologic deficit 
(neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT 
findings of neural compression (neural compression is defined as disc herniation 
or central or foraminal spinal stenosis),  
2. Failed 6 weeks of conservative treatment (conservative treatment is defined as 
relative rest, home exercise, physical therapy, and use of anti-inflammatory 
and/or analgesic medications),  
3. Deemed to be good operative candidates by spine surgeons (patients with 
MRI/CT findings of neural compression with concordant symptoms) and had 
agreed to possible operative intervention 
 
Exclusion Criteria:  
1. History of  
a. acute trauma,  
b. diabetic neuropathy,  
c. active infection,  
2. Active progressive neurological deficit (neurologic is deficit defined as manual 
muscle testing less than 3/5), 
3. Medical condition that may affect the cervical spine neurological exam and/or 
pain assessment (e.g. peripheral neuropathy),  
4. More than one cervical level requiring injection, 
5. Previous cervical fusion surgery, 
6. Bleeding disorders or other medical contraindications to the injection 
procedure, 
7. Absence of substantial radicular pain (radicular pain is defined as arm pain 
greater than neck pain),  
8. Involvement in workers' compensation claim, or any litigation related to neck 
injury. 
9. Patients who are pregnant, or who plan to become pregnant in the next 12 
months 
 
Data Collection and Treatment Administration 
 
Data Collection 
 
Screening Visit 
The primary operator or blinded investigator and/or designee will screen patients for 
potential participation in the study.  The following data points will be collected for all 
patients: 
 
 Informed Consent 
 Patient demographics (medical record number, age, gender, ethnicity, body 
mass index (BMI), 

 Patient medical history (smoking history, acute trauma, diabetes (type I or type 
II), active infection, active progressive neurological deficit, bilateral disease, 
bleeding disorders or other medical contraindications to the injection procedure, 
presence of radicular pain) 
 NDI questionnaire (disease specific measure), Verbal Numeric Pain Score, Pain 
Medication Use, and Neurological Exam 
 
Blinding 
This is a double-blind study (i.e., the patient and the blinded investigator are both 
unaware of the specific study treatment being administered).   
 
This protocol requires two types of investigators: primary operators and blinded 
investigators.  The principal investigator and co-investigator(s) will determine who 
serves as primary operator and blinded investigator for each site. The site must clearly 
designate these roles prior to initiation of the study. 
 
The primary operator will perform the primary study procedure.  The primary operator 
is not blind to study treatment as he/she has to deliver the assigned therapy. 
 
The blinded investigator will be blinded to study treatment and will perform all follow-
up medical evaluations.   
 
Methods used to preserve blinding are described in the relevant sections below. 
 
Randomization  
After obtaining informed consent, patients will be randomized by independent party to 
one of the two treatment groups. Patients will be randomized to either receive Cervical 
transforaminal injections with 1.0 cc of preservative-free lidocaine 1.0% and 1.0 cc of 
normal saline, or to receive Cervical transforaminal injections with 1.0cc of preservative-
free Lidocaine and Dexamethasone (10mg/cc).  A 1:1 randomization schedule will be 
followed. A random number generator will be used to determine the randomization 
schedule.  
 
Within the operating room, staff will open the sealed Randomization Envelope (which 
has been prepared for the site in sequential order).  Envelopes will be opened in the 
order for which patients are treated.  The staff will notify the primary operator as 
necessary. Do NOT call out the randomization; show the primary operator the 
randomization sheet within the envelope. The randomization sheet will be filed in the 
patient’s surgery center records and the primary operator will be instructed to dictate 
that the patient had a study injection and will not disclose the randomization.  
 
Treatment Administration 
 
Subjects will be scheduled to receive up to four cervical transforaminal injections after 
randomization. The injections will be scheduled at least 14 days apart and they will 

receive no more than four injections within the 12 month period per the North American 
Spine Society (NASS) Review and Recommendation Statement. 
 
The study procedure is performed by the primary operator. The blinded investigator 
must not be present.  
  
Standardized procedure to be performed by OrthoCarolina physiatrists, using a 
technique similar to the following: 
 
Patient will be sterilely prepped with a triple scrub of Betadine solution and sterilely 
draped.  Careful attention will be paid to aseptic technique throughout the procedure.  
The appropriate cervical neural foramen will be identified under fluoroscopic guidance.  
The overlying skin and subcutaneous tissues will be anesthetized with approximately 
1.0-3.0 cc of 1% Lidocaine.  A spinal needle will be inserted down to the neuroforamen 
and into the epidural space.  Approximately 1.0-3.0 cc of iodinated contrast will be 
infiltrated under real-time fluoroscopy and digital subtraction angiography to 
demonstrate satisfactory spread along the exiting spinal nerve and tracking into the 
epidural space without vascular uptake. This will be verified by spot films. A solution 
containing either a) 1.0 cc of preservative-free Lidocaine 1.0% and 1.0 cc of normal 
saline, or b) 1.0 cc of preservative-free Lidocaine 1.0% and 1.0 cc of solution (non-
particulate) Dexamethasone (10 mg/cc) will be slowly infiltrated around the spinal nerve 
and into the epidural space under real-time fluoroscopy.  There should be good contrast 
washout.  The needle will be removed.   
 
The primary operator will not have any further contact with the patient unless in the case 
of a medical emergency.  All post-procedure assessments will be completed by the 
blinded follow-up physician (or designated blinded study personnel) as directed in the 
protocol.  This includes the neurological exam and blinding assessment questionnaire. 
 
Follow-up Phone Calls to Patient/Additional Injections 
Patients will be scheduled for two (2) injections initially; these will be at least 14 days 
apart. One week (± 3 days) after the first injection subjects will be contacted by phone. 
The study coordinator will tell the subject their baseline, pre-procedure Verbal Numeric 
Pain Rating (a verbal assessment of pain using an 11-point scale of 0 – 10, with 0 = No 
Pain, and 10 = Worst Pain Imaginable) for radicular pain, and ask the subject to rate 
their current radicular pain intensity. Patients will also be asked to rate their overall 
satisfaction with their treatment and their current narcotic medication use. In the event 
that the subject wishes to decline the additional injection(s), the following steps will be 
taken: 
 
Refusal of second injection:   
If the subject’s pain rating score has decreased and the subject reports satisfaction with 
the results of the first injection, the second injection may be cancelled after review and 
approval by the investigator. The patient will continue to follow-up at the remaining 
study intervals (i.e., 4 weeks, 12 weeks, 6 months, 12 months). If the patient requires 

another injection at a later date (i.e., the pain relief from the first injection was 
temporary), then they may receive up to 3 additional injections within a 12 month period.  
 
If the subject’s pain rating score has increased or the subject reports dissatisfaction with 
the results of the first injection, the second injection may be cancelled after review and 
approval by the investigator and the patient will be referred back to the surgeon to 
proceed with the procedure. 
 
Third and Fourth Injections (as needed) 
Patients may schedule a third and fourth injection as needed. The study coordinator will 
call the patient one week (± 3 days) after the subsequent injection(s). The study 
coordinator will tell the subject their baseline, pre-procedure Verbal Numeric Pain 
Rating (a verbal assessment of pain using an 11-point scale of 0 – 10, with 0 = No Pain, 
and 10 = Worst Pain Imaginable) for radicular pain, and ask the subject to rate their 
current radicular pain intensity.  
 
Refusal of fourth injection:   
If the subject’s pain rating score has decreased and the subject reports satisfaction with 
the results of the third injection, the fourth injection may not be scheduled. The patient 
will continue to follow-up at the remaining study intervals (i.e., 4 weeks, 12 weeks, 6 
months, 12 months). If the patient requires another injection at a later date (i.e., the pain 
relief from the third injection was temporary), then they may receive up to 1 additional 
injection within a 12 month period.  
 
If the subject’s pain rating score has increased or the subject reports dissatisfaction with 
the results of the third injection, the patient may be referred back to the surgeon to 
proceed with the procedure. 
 
Study patients can elect to abandon the injection treatment and elect to undergo 
surgical treatment at any point during the course of the study. It is defined as treatment 
failure if a study patient elects to undergo surgical treatment. Patients who elect to 
undergo surgery will be discontinued from the study and no further effectiveness 
evaluations will be performed. Patients, referring physicians, and evaluating physician 
assistants are blinded to the treatment group. The treating physiatrist will not be blinded 
to the medications but will not be performing any clinical follow-up exams.  
 
Follow-up Office Visits 
Patients will be asked to return to the clinic 4 weeks, 12 weeks, 6 months, 12 months 
(following their first injection date) and the following data points will be collected for both 
groups: 
 
 NDI questionnaire (disease specific measure), Verbal Numeric Pain Score, 
Blinding Assessment (patient and investigator), Pain Medication Use, 
Neurological Exam, and Subject satisfaction. 
 

In the event that the patient receives their second, third, or fourth injection within 1 week 
prior to one of their follow-up office visits, the post injection phone call data will be 
collected at that visit. The study coordinator will tell the subject their baseline, pre-
procedure Verbal Numeric Pain Rating and ask the subject to rate their current radicular 
pain intensity. Patients will also be asked to rate their overall satisfaction with their 
treatment and their current narcotic medication use. 
The full schedule of assessments is shown in study flow chart below. 
 
Study Flow Chart: 
 
Study procedure 
Screening 
0 (day of 
procedure, 
injection 
#1) 
Phone 
Call  
Injection 
#2 (At 
least 14-
21 days 
after #1) 
4 weeks 
post 
injection 
12 
weeks 
post 
injection 
6 
months 
post 
injection 
12 
months 
post 
injection 
Informed Consent 
x 
  
  
  
  
  
  
  
Inclusion/Exclusion 
x 
  
  
  
  
  
  
  
Verbal Numeric Pain Score** 
x 
  
x 
  
 x 
 x 
 x 
 x 
NDI 
x 
  
  
  
x 
x 
x 
x 
Neuro Exam 
x 
  
  
  
x 
x 
x 
x 
Injection* 
  
x 
  
x 
  
  
  
  
Blinding Assessment -
Patient 
 
 
 
 
X 
X 
X 
X 
Blinding Assessment -
Investigator 
 
 
 
 
X 
X 
X 
X 
Pain Medication Use 
x 
x 
x 
x 
x 
x 
x 
x 
Subject satisfaction  
  
  
x 
  
x 
x 
x 
x 
Adverse Events 
  
  
x 
x 
x 
x 
x 
x 
* Patients may receive up to four injections within the 12 month period. Injections will be 
scheduled at least 14 days apart. 
** Patients will be called one week after injection 1, 3 (as needed), and 4 (as needed) 
***If an injection occurs within 1 week prior to follow-up visits, patient will not be called. Verbal 
Numeric Pain Scale, Pain Medication Use, Subject Satisfaction and Adverse Events will be 
recorded during the follow-up visit. 
 
Unblinding Procedures  
Patients will not be unblinded to their study treatment. Unblinding of patients will only 
occur by the data manager and statisticians in the event of an SAE that is deemed 
possibly or probably related. Subjects that have been “blind-broken” must be 
discontinued from the study and no further effectiveness evaluations will be performed. 
However, the SAE will continue to be followed up until resolution.  
 
Sample Size 
Sample size calculations are based on the study by Riew et al. (2000). We estimate that 
30% patients randomized to Lidocaine will avoid surgery compared to 70% of the 
patients randomized to Lidocaine with Dexamethasone. With a level of significance of 
0.05 and power of 80%, 23 patients are needed in each group. To account for a 30% 
attrition rate, 30 patients are needed in each group. The total enrollment goal is 60 
patients. 

 
Risks 
As with all medications, side effects may include an allergic reaction.  Allergic reactions 
may range from minor reactions, such as itching or rash, to major, life-threatening 
reactions which can result in death. 
 
Risks associated with cervical transforaminal injections include, but are not limited to: 
 
Likely 
 Spinal headache;  
 
Less Likely 
 Nerve irritation;  
 Nerve injury;  
 The risk of bleeding and/or infection into the spinal area;  
 Reaction to medications;  
 
Rare, but Serious 
 Lung collapse;  
 Seizures 
 Paralysis 
 Loss of vision 
 Stroke 
 Death.   
 
 
Risks of general anesthesia or moderate sedation include, but are not limited to: 
 
The most common side effects may include: 
 Headache  
 Adverse reaction to medications 
 
Less common side effects of may include: 
 Bleeding sufficient to cause anemia or require transfusion 
 Hematoma (bleeding from the procedure) 
 Pseudoaneurysm (injury to a blood vessel) 
 Seroma (a collection of fluid under the skin) 
 Blood vessel injury 
 Pneumonia 
 
Rarely, side effects may include: 
 Hypotension (drop in blood pressure) 
 Cardiopulmonary arrest (heart attack) 
 Stroke 
 Pulmonary embolism (a blood clot to your lungs) 

 Death 
 
Risks associated with contrast agents that are used in the procedure include, but are 
not limited to: 
 Allergic reaction 
 Anaphylaxis 
 Death   
Risks associated with the Lidocaine (anesthetic medication) that is used in the 
procedure include, but are not limited to: 
 temporary numbness of arm 
 seizures 
 
Risks associated with the Dexamethasone (steroid medication) that may be used in the 
procedure include, but are not limited to: 
 Hypersensitivity 
 Transient jitters 
 Flushing 
 Elevated Blood Sugars 
 Headache 
 
Long-term and chronic use is associated with Dexamethasone use includes: avascular 
necrosis, osteoporosis (condition where your bones become brittle and may break 
easier), weight gain, or Cushing's syndrome. 
 
Additional risks include the potential for a breach of confidentiality.  The research 
involves the collection or study of existing data, documents, and/or records (for medical 
history purposes) at OrthoCarolina and Charlotte Surgery Center. Once the data is 
collected, the data set will be de-identified for the data analysis and manuscript. The 
data will be handled by OrthoCarolina/OrthoCarolina Research Institute staff and 
physicians and will not be shared with any external parties. 
 
Data Management 
All case report forms (CRF) will be completed and submitted for review to the Study 
Manager within a reasonable time frame. After approval, completed CRF’s will be 
entered into a password protected, secure REDCap database (http://project-
redcap.org/) by the data management team of OrthoCarolina Research Institute, on at 
least a weekly basis. REDCap is a secure web application designed exclusively to 
support data capture for research studies. It allows users to build and manage online 
surveys and databases quickly and securely with site and personnel specific usernames 
and passwords. REDCap provides audit trails for tracking data manipulation and user 
activity, as well as automated export procedures for seamless data downloads to Excel, 
PDF, and common statistical packages like SPSS, SAS, and Stata. Completed CRF’s 
and other identifiable study documents will be stored securely in a locked filing cabinet 
in a locked office. 
 
 

 
Statistical analysis 
Normality testing will be conducted for all continuous variables. Standard descriptive 
statistics will be calculated for patient demographic variables as well as the primary and 
secondary outcome variables. For variables measure at the ordinal level (i.e. categorical 
data) frequencies and percentages will be reported. Mean and standard deviation will 
be reported for all normally distributed data measured as intervals or ratios (i.e. 
continuous data). Median and interquartile range will be reported for continuous 
variables that are skewed. The incidence of surgery avoidance will be calculated. 
Bivariate analyses will be conducted to determine the associations between surgery 
avoidance and age, gender, pain, function, pain medicine consumption, BMI and 
subject satisfaction. Chi-Square tests will be used for categorical data and t-test or the 
nonparametric equivalent will be used for continuous data. 
 
Adverse Event Reporting 
Adverse events such as, death or any other complication will be reported to the IRB.  
 
Subjects will be instructed to report any "Serious Adverse Event" immediately to the 
investigator.  
 
"Serious Adverse Event" is defined as any event that: 
 Results in death 
 Is life-threatening 
 Results in persistent or significant disabling/incapacity 
 Requires inpatient hospitalization or prolongation of hospitalization 
 Is a congenital abnormality/birth defect 
 Requires medical or surgical intervention to prevent permanent impairment or 
damage 
 
Serious adverse events will be reported to Presbyterian Healthcare Institutional 
Review Board within 24 hours of the event. This report may be done by phone 
initially and will follow with an adverse event report form.  
 
Data Safety Monitoring  
A Data Safety Monitoring Board will review data for integrity. 
 
Robert Anderson, M.D., Chairman, Research Committee will serve as the safety 
monitor. A data safety monitoring board (DSMB) will review data on a bi-monthly basis 
or as needed. The DSMB are members of the OrthoCarolina Research Institute (OCRI) 
Research Advisory Committee.   
 
Data Safety Monitoring Plan 
Serious adverse events (SAEs) that are “related,” “probably related” or have an 
“unknown” relatedness to the study procedure, will be reported to the data safety 
monitoring board via email as they occur. The data safety monitoring board meets every 

other month. At each meeting the study will be reviewed for adverse events, serious 
adverse events, and overall feasibility issues. 
 
Ethical and Regulatory Considerations 
 Informed Consent 
Informed consent will be obtained for each patient.  One copy of the informed 
consent will be given to each patient, a copy will be placed in the medical 
records, and the original signed copy will be retained in the investigator’s 
study records. The protocol and the patient informed consent will have the 
approval of a properly constituted IRB responsible for approving clinical 
studies.  Any changes to the protocol will be approved by the IRB and any 
changes to the informed consent must be approved by the IRB. 
 Applicable regulations 
This is an Investigator Initiated Research Study and will be conducted in 
compliance with the protocol approved by the Institutional Review Board, and 
according to Good Clinical Practice standards.  No deviation from the protocol 
will be implemented without the prior review and approval of the IRB except 
where it may be necessary to eliminate an immediate hazard to a research 
subject.  In such case, the deviation will be reported to the IRB as soon as 
possible. 
 
Records Retention 
All patient records including written informed consent forms, the protocol, and IRB 
correspondence will be kept for a minimum of three years from the date of termination 
of this study. 
 
Data Collection forms 
See Attached forms 
 
Definition of Subject Completion, Withdrawal, and Premature Discontinuation 
Subject completion 
A subject will be considered to be completed if the patient completes all study 
procedures and follow-up. 
 
Withdrawal and Premature Discontinuation 
Patients may be withdrawn or prematurely discontinued from the study of their own 
volition or at the discretion of the investigator. Any patient may decide to withdraw from 
the study at any time without being penalized. The investigator and/or anesthesiologist 
will discontinue the patient from the study, if, for any reason, he/she feels that the 
continued participation would not be in the best interest of the patient.  
 
Study Completion and Termination 
The study is completed when the desired sample size of patients have completed the 
study or if the investigator feels that the study should no longer continue. The 
institutional review board will be notified of study completion and/or termination. 
 

 
 
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