Trial Outcomes & Findings for Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (NCT NCT02226159)
NCT ID: NCT02226159
Last Updated: 2025-08-11
Results Overview
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.
COMPLETED
PHASE4
65 participants
12 months after the first injection
2025-08-11
Participant Flow
Participant milestones
| Measure |
Lidocaine
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
Baseline characteristics by cohort
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
53.5 years
n=107 Participants
|
52 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
26 participants
n=107 Participants
|
53 participants
n=206 Participants
|
|
Verbal Numeric Pain Score
|
5 units on a scale
n=99 Participants
|
7 units on a scale
n=107 Participants
|
6.5 units on a scale
n=206 Participants
|
|
Neck Disability Index
|
33 units on a scale
n=99 Participants
|
35 units on a scale
n=107 Participants
|
34 units on a scale
n=206 Participants
|
|
Patient Satisfaction
|
5 units on a scale
n=99 Participants
|
3 units on a scale
n=107 Participants
|
3.5 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Avoidance of Neck Surgery
No(had surgery)
|
24 Participants
|
20 Participants
|
|
Avoidance of Neck Surgery
Yes (Did not have surgery)
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 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).
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Disability
|
25.2 units on a scale
Standard Deviation 14.1
|
22.8 units on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: 4 weeksVerbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Numeric Pain Scre
|
3.7 score on a scale
Standard Deviation 2.8
|
3.8 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 4 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
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Patient Satisfaction
|
6.3 score on a scale
Standard Deviation 2.8
|
6.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 12 weeksNeck 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).
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Disability
|
25.1 units on a scale
Standard Deviation 15.3
|
18.3 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 6 MonthsNeck 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).
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Disability
|
19.4 units on a scale
Standard Deviation 14.0
|
16.3 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 12 MonthsNeck 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).
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Disability
|
16.4 units on a scale
Standard Deviation 14.4
|
15.4 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 12 weeksVerbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Numeric Pain Score
|
3.6 score on a scale
Standard Deviation 2.4
|
3.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 MonthsVerbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Numeric Pain Score
|
3.0 score on a scale
Standard Deviation 2.4
|
2.2 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 12 MonthsVerbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Numeric Pain Score
|
2.9 score on a scale
Standard Deviation 2.8
|
3.2 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 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
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Patient Satisfaction
|
6.4 score on a scale
Standard Deviation 2.4
|
6.6 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 6 monthsPatient 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
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Patient Satisfaction
|
7.0 score on a scale
Standard Deviation 2.4
|
7.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 12 monthsPatient 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
Outcome measures
| Measure |
Lidocaine
n=27 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 Participants
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
Patient Satisfaction
|
7.2 score on a scale
Standard Deviation 2.8
|
6.8 score on a scale
Standard Deviation 3.1
|
Adverse Events
Lidocaine
Lidocaine With Dexamethasone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine
n=27 participants at risk
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Lidocaine
|
Lidocaine With Dexamethasone
n=26 participants at risk
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Lidocaine with Dexamethasone
|
|---|---|---|
|
General disorders
Numbness and tingling
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Fever
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
0.00%
0/26 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Flu-like symptoms
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
0.00%
0/26 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Headache
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
11.5%
3/26 • Number of events 3 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
Musculoskeletal and connective tissue disorders
Increased arm/neck pain
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
26.9%
7/26 • Number of events 7 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
chest pain
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Dizziness
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Nausea
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
7.7%
2/26 • Number of events 2 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
hot/flushed feeling
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
|
General disorders
Pain at injection site
|
0.00%
0/27 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
3.8%
1/26 • Number of events 1 • Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place