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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02226159
Recruitment Status : Active, not recruiting
First Posted : August 27, 2014
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Charlotte Surgery Center an affiate of SCA
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain, Radiating
Interventions Drug: Lidocaine
Drug: Lidocaine with Dexamethasone
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Period Title: Overall Study
Started 33 32
Completed 27 26
Not Completed 6 6
Arm/Group Title Lidocaine Lidocaine With Dexamethasone Total
Hide Arm/Group Description

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Total of all reporting groups
Overall Number of Baseline Participants 27 26 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 27 participants 26 participants 53 participants
50
(44 to 58)
53.5
(46 to 62)
52
(45 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Female
17
  63.0%
15
  57.7%
32
  60.4%
Male
10
  37.0%
11
  42.3%
21
  39.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
Hispanic or Latino
26
  96.3%
24
  92.3%
50
  94.3%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.7%
2
   7.7%
3
   5.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 26 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   7.4%
0
   0.0%
2
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  33.3%
3
  11.5%
12
  22.6%
White
16
  59.3%
22
  84.6%
38
  71.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.8%
1
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 26 participants 53 participants
27 26 53
Verbal Numeric Pain Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 26 participants 53 participants
5
(5 to 7)
7
(5 to 8)
6.5
(5 to 8)
[1]
Measure Description: On a scale of 1-10 with 10 indicating the greatest among of pain
Neck Disability Index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 26 participants 53 participants
33
(26 to 40)
35
(24 to 48)
34
(26 to 44)
[1]
Measure Description: Scored from 0-50, with 50 indicating the greatest amount of disability
Patient Satisfaction   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 27 participants 26 participants 53 participants
5
(3 to 5)
3
(2 to 5)
3.5
(2 to 5)
[1]
Measure Description: Scored from 0-10 with 10 indicating the greatest among of patient satisfaction
1.Primary Outcome
Title Avoidance of Neck Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Measure Type: Count of Participants
Unit of Measure: Participants
No(had surgery)
24
  88.9%
20
  76.9%
Yes (Did not have surgery)
3
  11.1%
6
  23.1%
2.Secondary Outcome
Title Disability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.2  (14.1) 22.8  (17.2)
3.Secondary Outcome
Title Numeric Pain Scre
Hide Description Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.7  (2.8) 3.8  (2.9)
4.Secondary Outcome
Title Patient Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.3  (2.8) 6.2  (2.9)
5.Secondary Outcome
Title Disability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.1  (15.3) 18.3  (18.4)
6.Secondary Outcome
Title Disability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.4  (14.0) 16.3  (17.5)
7.Secondary Outcome
Title Disability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.4  (14.4) 15.4  (10.2)
8.Secondary Outcome
Title Numeric Pain Score
Hide Description Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.6  (2.4) 3.4  (3.0)
9.Secondary Outcome
Title Numeric Pain Score
Hide Description Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.0  (2.4) 2.2  (2.8)
10.Secondary Outcome
Title Numeric Pain Score
Hide Description Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.9  (2.8) 3.2  (3.1)
11.Secondary Outcome
Title Patient Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.4  (2.4) 6.6  (3.0)
12.Secondary Outcome
Title Patient Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.0  (2.4) 7.8  (2.8)
13.Secondary Outcome
Title Patient Satisfaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description:

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.2  (2.8) 6.8  (3.1)
Time Frame Adverse Events (AEs) are collected at weeks 1, 2, 3, 4, and 12, then at 6 months and 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lidocaine Lidocaine With Dexamethasone
Hide Arm/Group Description

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline

Lidocaine

Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)

Lidocaine with Dexamethasone

All-Cause Mortality
Lidocaine Lidocaine With Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/26 (0.00%)    
Hide Serious Adverse Events
Lidocaine Lidocaine With Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lidocaine Lidocaine With Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/27 (11.11%)      9/26 (34.62%)    
General disorders     
Numbness and tingling *  1/27 (3.70%)  1 1/26 (3.85%)  1
Fever *  1/27 (3.70%)  1 0/26 (0.00%)  0
Flu-like symptoms *  1/27 (3.70%)  1 0/26 (0.00%)  0
Headache *  1/27 (3.70%)  1 3/26 (11.54%)  3
chest pain *  0/27 (0.00%)  0 1/26 (3.85%)  1
Dizziness *  0/27 (0.00%)  0 1/26 (3.85%)  1
Nausea *  0/27 (0.00%)  0 2/26 (7.69%)  2
hot/flushed feeling *  0/27 (0.00%)  0 1/26 (3.85%)  1
Pain at injection site *  0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders     
Increased arm/neck pain *  1/27 (3.70%)  1 7/26 (26.92%)  7
Respiratory, thoracic and mediastinal disorders     
shortness of breath *  0/27 (0.00%)  0 1/26 (3.85%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Odum
Organization: OrthoCarolina Research Institute
Phone: 7049457710
EMail: susan.odum@orthocarolina.com
Publications:
Layout table for additonal information
Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02226159    
Other Study ID Numbers: 9086-14019
First Submitted: August 25, 2014
First Posted: August 27, 2014
Results First Submitted: September 1, 2020
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020