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Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain

Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02226159
Acronym
SPIES
Enrollment
65
Registered
2014-08-27
Start date
2014-08-31
Completion date
2024-12-31
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Radiating

Keywords

cervical, radicular pain, transforaminal epidural steroid injections

Brief summary

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. 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. 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.

Detailed description

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.

Interventions

DRUGLidocaine
DRUGLidocaine with Dexamethasone

Sponsors

Charlotte Surgery Center
CollaboratorOTHER
OrthoCarolina Research Institute, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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), * 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), * 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

* History of 1. acute trauma, 2. diabetes (type I or type II), 3. active infection * Active progressive neurological deficit (neurologic is deficit defined as manual muscle testing less than 3/5), * Medical condition that may affect the cervical spine neurological exam and/or pain assessment (e.g. peripheral neuropathy), * Bilateral disease, * More than one cervical level requiring injection, * Bleeding disorders or other medical contraindications to the injection procedure, * Absence of substantial radicular pain (radicular pain is defined as arm pain greater than neck pain), * Involvement in workers' compensation claim, or any litigation related to neck injury. * Patients who are pregnant, or who plan to become pregnant in the next 12 months

Design outcomes

Primary

MeasureTime frameDescription
Avoidance of Neck Surgery12 months after the first injectionThe 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. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.

Secondary

MeasureTime frameDescription
Disability4 weeksNeck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
Numeric Pain Scre4 weeksVerbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Patient Satisfaction4 weeksPatient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
Numeric Pain Score12 weeksVerbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain

Countries

United States

Participant flow

Participants by arm

ArmCount
Lidocaine
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline Lidocaine
27
Lidocaine With Dexamethasone
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc) Lidocaine with Dexamethasone
26
Total53

Baseline characteristics

CharacteristicTotalLidocaineLidocaine With Dexamethasone
Age, Continuous52 years50 years53.5 years
Ethnicity (NIH/OMB)
Hispanic or Latino
50 Participants26 Participants24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants2 Participants
Neck Disability Index34 units on a scale33 units on a scale35 units on a scale
Patient Satisfaction3.5 units on a scale5 units on a scale3 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
12 Participants9 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
38 Participants16 Participants22 Participants
Region of Enrollment
United States
53 participants27 participants26 participants
Sex: Female, Male
Female
32 Participants17 Participants15 Participants
Sex: Female, Male
Male
21 Participants10 Participants11 Participants
Verbal Numeric Pain Score6.5 units on a scale5 units on a scale7 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 26
other
Total, other adverse events
3 / 279 / 26
serious
Total, serious adverse events
0 / 270 / 26

Outcome results

Primary

Avoidance of Neck Surgery

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. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.

Time frame: 12 months after the first injection

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
LidocaineAvoidance of Neck SurgeryNo(had surgery)24 Participants
LidocaineAvoidance of Neck SurgeryYes (Did not have surgery)3 Participants
Lidocaine With DexamethasoneAvoidance of Neck SurgeryNo(had surgery)20 Participants
Lidocaine With DexamethasoneAvoidance of Neck SurgeryYes (Did not have surgery)6 Participants
Secondary

Disability

Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
LidocaineDisability25.2 units on a scaleStandard Deviation 14.1
Lidocaine With DexamethasoneDisability22.8 units on a scaleStandard Deviation 17.2
Secondary

Disability

Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).

Time frame: 12 Months

ArmMeasureValue (MEAN)Dispersion
LidocaineDisability16.4 units on a scaleStandard Deviation 14.4
Lidocaine With DexamethasoneDisability15.4 units on a scaleStandard Deviation 10.2
Secondary

Disability

Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
LidocaineDisability25.1 units on a scaleStandard Deviation 15.3
Lidocaine With DexamethasoneDisability18.3 units on a scaleStandard Deviation 18.4
Secondary

Disability

Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
LidocaineDisability19.4 units on a scaleStandard Deviation 14
Lidocaine With DexamethasoneDisability16.3 units on a scaleStandard Deviation 17.5
Secondary

Numeric Pain Score

Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain

Time frame: 12 Months

ArmMeasureValue (MEAN)Dispersion
LidocaineNumeric Pain Score2.9 score on a scaleStandard Deviation 2.8
Lidocaine With DexamethasoneNumeric Pain Score3.2 score on a scaleStandard Deviation 3.1
Secondary

Numeric Pain Score

Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
LidocaineNumeric Pain Score3.6 score on a scaleStandard Deviation 2.4
Lidocaine With DexamethasoneNumeric Pain Score3.4 score on a scaleStandard Deviation 3
Secondary

Numeric Pain Score

Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
LidocaineNumeric Pain Score3.0 score on a scaleStandard Deviation 2.4
Lidocaine With DexamethasoneNumeric Pain Score2.2 score on a scaleStandard Deviation 2.8
Secondary

Numeric Pain Scre

Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
LidocaineNumeric Pain Scre3.7 score on a scaleStandard Deviation 2.8
Lidocaine With DexamethasoneNumeric Pain Scre3.8 score on a scaleStandard Deviation 2.9
Secondary

Patient Satisfaction

Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
LidocainePatient Satisfaction7.0 score on a scaleStandard Deviation 2.4
Lidocaine With DexamethasonePatient Satisfaction7.8 score on a scaleStandard Deviation 2.8
Secondary

Patient Satisfaction

Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
LidocainePatient Satisfaction6.4 score on a scaleStandard Deviation 2.4
Lidocaine With DexamethasonePatient Satisfaction6.6 score on a scaleStandard Deviation 3
Secondary

Patient Satisfaction

Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction

Time frame: 4 weeks

ArmMeasureValue (MEAN)Dispersion
LidocainePatient Satisfaction6.3 score on a scaleStandard Deviation 2.8
Lidocaine With DexamethasonePatient Satisfaction6.2 score on a scaleStandard Deviation 2.9
Secondary

Patient Satisfaction

Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
LidocainePatient Satisfaction7.2 score on a scaleStandard Deviation 2.8
Lidocaine With DexamethasonePatient Satisfaction6.8 score on a scaleStandard Deviation 3.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026