Trial Outcomes & Findings for Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach (NCT NCT03382821)
NCT ID: NCT03382821
Last Updated: 2022-11-25
Results Overview
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
120 participants
Primary outcome timeframe
1 month follow up
Results posted on
2022-11-25
Participant Flow
Participant milestones
| Measure |
Transforaminal ESI With Dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Transforaminal Catheter-targeted ESI With Triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Transforaminal ESI With Dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Transforaminal Catheter-targeted ESI With Triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
Overall Study
Did not receive allocated intervention.
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transforaminal ESI With Dexamethasone
n=60 Participants
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Interlaminar Catheter-targeted ESI With Triamcinolone
n=57 Participants
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=117 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=60 Participants
|
48 Participants
n=57 Participants
|
99 Participants
n=117 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=60 Participants
|
9 Participants
n=57 Participants
|
18 Participants
n=117 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=60 Participants
|
32 Participants
n=57 Participants
|
66 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=60 Participants
|
25 Participants
n=57 Participants
|
51 Participants
n=117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
57 participants
n=57 Participants
|
117 participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 1 month follow upPopulation: \>50% Pain Reduction scored with 95% Confidence Interval.
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
Outcome measures
| Measure |
Transforaminal ESI With Dexamethasone
n=60 Participants
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Interlaminar Catheter-targeted ESI With Triamcinolone
n=57 Participants
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
|
49.1 percentage of participants
Interval 36.4 to 62.0
|
68.5 percentage of participants
Interval 54.9 to 79.5
|
SECONDARY outcome
Timeframe: 1 month, 3 month, 6 month, and 1 year follow upPopulation: Analysis was done for different timelines of one month, three months, six months, and one year.
Percentage of patients with \>30% improvement in Neck Disability Index-5 score.
Outcome measures
| Measure |
Transforaminal ESI With Dexamethasone
n=60 Participants
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Interlaminar Catheter-targeted ESI With Triamcinolone
n=57 Participants
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
Neck Disability Index-5
One month
|
48 percentage of participants
Interval 35.0 to 61.0
|
62 percentage of participants
Interval 49.0 to 75.0
|
|
Neck Disability Index-5
Three month
|
56 percentage of participants
Interval 43.0 to 69.0
|
58 percentage of participants
Interval 45.0 to 72.0
|
|
Neck Disability Index-5
Six month
|
55 percentage of participants
Interval 41.0 to 69.0
|
56 percentage of participants
Interval 43.0 to 69.0
|
|
Neck Disability Index-5
One year
|
47 percentage of participants
Interval 33.0 to 61.0
|
60 percentage of participants
Interval 47.0 to 74.0
|
SECONDARY outcome
Timeframe: 1 month, 3 month, 6 month, and 1 year follow upPopulation: Analysis was done for different timelines of one month, three months, six months, and one year.
The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents.
Outcome measures
| Measure |
Transforaminal ESI With Dexamethasone
n=60 Participants
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Interlaminar Catheter-targeted ESI With Triamcinolone
n=57 Participants
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
One month
|
16 percentage of participants
Interval 6.0 to 25.0
|
19 percentage of participants
Interval 8.0 to 29.0
|
|
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
Three month
|
20 percentage of participants
Interval 9.0 to 31.0
|
17 percentage of participants
Interval 7.0 to 27.0
|
|
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
Six month
|
15 percentage of participants
Interval 5.0 to 24.0
|
19 percentage of participants
Interval 8.0 to 29.0
|
|
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
One year
|
7 percentage of participants
Interval 4.0 to 22.0
|
8 percentage of participants
Interval 6.0 to 27.0
|
SECONDARY outcome
Timeframe: 1 month, 3 month, 6 month, and 1 year follow upPopulation: Analysis was done for different timelines of one month, three months, six months, and one year.
Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved")
Outcome measures
| Measure |
Transforaminal ESI With Dexamethasone
n=60 Participants
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
|
Interlaminar Catheter-targeted ESI With Triamcinolone
n=57 Participants
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
|
|---|---|---|
|
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
Three months
|
42 percentage of participants
Interval 28.0 to 56.0
|
57 percentage of participants
Interval 43.0 to 70.0
|
|
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
Six months
|
55 percentage of participants
Interval 40.0 to 69.0
|
53 percentage of participants
Interval 39.0 to 67.0
|
|
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
One year
|
57 percentage of participants
Interval 42.0 to 73.0
|
61 percentage of participants
Interval 45.0 to 76.0
|
|
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
One month
|
41 percentage of participants
Interval 28.0 to 54.0
|
59 percentage of participants
Interval 46.0 to 72.0
|
Adverse Events
Transforaminal ESI With Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interlaminar Catheter-targeted ESI With Triamcinolone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Zachary McCormick
University of Utah, Department of Physical Medicine and Rehabilitation
Phone: 801-587-5432
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place