Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain

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: NCT02095197
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Radicular; Neuropathic, Cervical
Neck Pain
Intervention Drug: Triamcinolone 80mg
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Period Title: Overall Study
Started 40 39
Completed 40 36
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             3
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery Total
Hide Arm/Group Description

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Total of all reporting groups
Overall Number of Baseline Participants 40 36 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 36 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  92.5%
32
  88.9%
69
  90.8%
>=65 years
3
   7.5%
4
  11.1%
7
   9.2%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 40 participants 36 participants 76 participants
47
(39 to 56)
50
(45 to 60)
49
(42 to 58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 36 participants 76 participants
Female
25
  62.5%
20
  55.6%
45
  59.2%
Male
15
  37.5%
16
  44.4%
31
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 36 participants 76 participants
40 36 76
1.Primary Outcome
Title Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
Hide Description

The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period.

Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain).

Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description:

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Overall Number of Participants Analyzed 38 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60
(45 to 75)
72
(57 to 87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Catheter Delivery, Catheter Targeted Delivery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)
Hide Description The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject’s medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description:

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Overall Number of Participants Analyzed 40 36
Measure Type: Count of Participants
Unit of Measure: Participants
13
  32.5%
9
  25.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Catheter Delivery, Catheter Targeted Delivery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Patient Global Impression of Change Score (PGIC) Less Than 3
Hide Description

PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as:

1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse.

A PGIC score less than 3 means the patient reported "much improved" to "very much improved."

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description:

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Overall Number of Participants Analyzed 40 36
Measure Type: Count of Participants
Unit of Measure: Participants
22
  55.0%
24
  66.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Catheter Delivery, Catheter Targeted Delivery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score
Hide Description This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Both demonstrate a difference from pretreatment baseline (P=0.05).
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description:

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Overall Number of Participants Analyzed 40 36
Measure Type: Count of Participants
Unit of Measure: Participants
23
  57.5%
24
  66.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Catheter Delivery, Catheter Targeted Delivery
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Catheter Delivery Catheter Targeted Delivery
Hide Arm/Group Description

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

No Catheter Delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Catheter targeted delivery will be used to deliver the medication.

Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

All-Cause Mortality
No Catheter Delivery Catheter Targeted Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Catheter Delivery Catheter Targeted Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Catheter Delivery Catheter Targeted Delivery
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/36 (0.00%) 
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: David Walega, MD
Organization: Northwestern University, Feinberg School of Medicine
Phone: 312-695-2500
EMail: d-walega@northwestern.edu
Layout table for additonal information
Responsible Party: David Walega, Northwestern University
ClinicalTrials.gov Identifier: NCT02095197     History of Changes
Other Study ID Numbers: STU00089080
STU00089080 ( Other Identifier: Northwestern University IRB )
First Submitted: March 20, 2014
First Posted: March 24, 2014
Results First Submitted: September 22, 2016
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017