Trial Outcomes & Findings for CESI With Low Dose Lidocaine and Transient Weakness (NCT NCT03127137)
NCT ID: NCT03127137
Last Updated: 2023-02-10
Results Overview
Change in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
123 participants
Primary outcome timeframe
30 minutes after the CESI procedure
Results posted on
2023-02-10
Participant Flow
159 subjects were assessed for eligibility. 27 declined to participate. 2 could not perform pre-study strength testing. 7 requested sedation for the injection.
Participant milestones
| Measure |
Experimental Group 1
Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2
Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Experimental Group 1
Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2
Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
|---|---|---|
|
Overall Study
Requested sedation after consent
|
1
|
0
|
|
Overall Study
Malfunction in electronic data collection
|
1
|
0
|
|
Overall Study
Post procedure testing could not be obtained
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group 1 With Lidocaine
n=60 Participants
Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2 With Saline
n=60 Participants
Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Years
|
56.6 years
STANDARD_DEVIATION 14 • n=60 Participants
|
56.3 years
STANDARD_DEVIATION 13.4 • n=60 Participants
|
56.5 years
STANDARD_DEVIATION 13.6 • n=120 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=60 Participants
|
26 Participants
n=60 Participants
|
56 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=60 Participants
|
34 Participants
n=60 Participants
|
64 Participants
n=120 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
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
|
Body Mass Index (kg/m^2)
|
26.5 BMI (kg/m^2)
STANDARD_DEVIATION 4.9 • n=60 Participants
|
29.2 BMI (kg/m^2)
STANDARD_DEVIATION 6.1 • n=60 Participants
|
27.8 BMI (kg/m^2)
STANDARD_DEVIATION 5.5 • n=120 Participants
|
|
Number of Participants with radicular pain based on myotome location
c 5 myotome
|
15 Participants
n=60 Participants
|
13 Participants
n=60 Participants
|
28 Participants
n=120 Participants
|
|
Number of Participants with radicular pain based on myotome location
c 6 myotome
|
29 Participants
n=60 Participants
|
30 Participants
n=60 Participants
|
59 Participants
n=120 Participants
|
|
Number of Participants with radicular pain based on myotome location
c 7 myotome
|
12 Participants
n=60 Participants
|
9 Participants
n=60 Participants
|
21 Participants
n=120 Participants
|
|
Number of Participants with radicular pain based on myotome location
c 8 myotome
|
0 Participants
n=60 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=120 Participants
|
|
Number of Participants with radicular pain based on myotome location
Missing myotome location
|
4 Participants
n=60 Participants
|
7 Participants
n=60 Participants
|
11 Participants
n=120 Participants
|
|
Numerical rating score(NRS) for pain
|
4.9 score on a scale
STANDARD_DEVIATION 2.3 • n=60 Participants
|
5.4 score on a scale
STANDARD_DEVIATION 2.4 • n=60 Participants
|
5.2 score on a scale
STANDARD_DEVIATION 2.3 • n=120 Participants
|
|
Number of participants with unilateral or bilateral symptoms
Unilateral
|
47 participants
n=60 Participants
|
47 participants
n=60 Participants
|
94 participants
n=120 Participants
|
|
Number of participants with unilateral or bilateral symptoms
Bilateral
|
13 participants
n=60 Participants
|
11 participants
n=60 Participants
|
24 participants
n=120 Participants
|
|
Number of participants with unilateral or bilateral symptoms
Missing
|
1 participants
n=60 Participants
|
1 participants
n=60 Participants
|
2 participants
n=120 Participants
|
|
Physical exam- weakness in any myotome, freq (%)
Yes weakness
|
3 participants
n=60 Participants
|
12 participants
n=60 Participants
|
15 participants
n=120 Participants
|
|
Physical exam- weakness in any myotome, freq (%)
No weakness
|
54 participants
n=60 Participants
|
47 participants
n=60 Participants
|
101 participants
n=120 Participants
|
|
Physical exam- weakness in any myotome, freq (%)
Missing data
|
3 participants
n=60 Participants
|
1 participants
n=60 Participants
|
4 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after the CESI procedureChange in strength in both groups greater than or equal to 20% weakness in one or more myotomes 30 minutes after CESI using a hand held Dynamometer.
Outcome measures
| Measure |
Experimental Group 1 With Lidocaine
n=60 Participants
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2 With Saline
n=60 Participants
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
|---|---|---|
|
Change in Strength in Both Groups After CESI.
Yes, greater or equal to 20% weakness in greater or equal to 1 or more myotome
|
25 Participants
|
30 Participants
|
|
Change in Strength in Both Groups After CESI.
No, greater or equal to 20% weakness in greater or equal to 1 or more myotome
|
35 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after the CESI procedure.Population: Patients whose baseline and post-NRS scores were both zero were excluded from this analysis.
A greater than or equal to 50% reduction in change in average pain score before and after the CESI procedure.
Outcome measures
| Measure |
Experimental Group 1 With Lidocaine
n=59 Participants
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2 With Saline
n=57 Participants
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
|---|---|---|
|
Number of Participants With Pain Reduction Post Procedure
Experienced greater than or equal to 50% reduction in pain
|
19 Participants
|
12 Participants
|
|
Number of Participants With Pain Reduction Post Procedure
Less than 50% reduction in pain
|
40 Participants
|
45 Participants
|
Adverse Events
Experimental Group 1 With Lidocaine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Experimental Group 2 With Saline
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group 1 With Lidocaine
n=60 participants at risk
Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
Experimental Group 1 triamcinolone and lidocaine: Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
|
Experimental Group 2 With Saline
n=60 participants at risk
Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
Experimental Group 2 triamcinolone and saline: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
|
|---|---|---|
|
Nervous system disorders
Vasovagal
|
1.7%
1/60 • Number of events 1 • 24 hours after the procedure.
|
3.3%
2/60 • Number of events 2 • 24 hours after the procedure.
|
|
Cardiac disorders
Cardiac rhythm changes
|
3.3%
2/60 • Number of events 2 • 24 hours after the procedure.
|
0.00%
0/60 • 24 hours after the procedure.
|
|
Nervous system disorders
Pain at injection site
|
1.7%
1/60 • Number of events 1 • 24 hours after the procedure.
|
1.7%
1/60 • Number of events 1 • 24 hours after the procedure.
|
|
Nervous system disorders
Paraesthesia/numbness
|
3.3%
2/60 • Number of events 2 • 24 hours after the procedure.
|
6.7%
4/60 • Number of events 4 • 24 hours after the procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place