Trial Outcomes & Findings for Effect of the Temperature Used in Thermal Radiofrequency Ablation (NCT NCT02148003)
NCT ID: NCT02148003
Last Updated: 2024-03-19
Results Overview
The primary outcome was the Visual Analog Scale (VAS) pain score at 30-day follow-up visit, which was collected by patients marking a position on a strip to indicate the intensity of their pain. The locations patients marked are translated into a score from 0-100, with 0 being no pain and 100 corresponding to the worst imaginable pain.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
30 days after the procedure
Results posted on
2024-03-19
Participant Flow
Participant milestones
| Measure |
RFA at 90 Degrees Celsius
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
RFA at 80 Degrees Celsius
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
RFA at 90 Degrees Celsius
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
RFA at 80 Degrees Celsius
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
|---|---|---|
|
Overall Study
Failed inclusion criteria
|
1
|
0
|
|
Overall Study
Met exclusion criteria
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race data was not collected..
Baseline characteristics by cohort
| Measure |
RFA at 90 Degrees Celsius
n=59 Participants
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
RFA at 80 Degrees Celsius
n=58 Participants
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 year
STANDARD_DEVIATION 13 • n=59 Participants
|
61 year
STANDARD_DEVIATION 14 • n=58 Participants
|
58 year
STANDARD_DEVIATION 13 • n=117 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=59 Participants
|
34 Participants
n=58 Participants
|
68 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=59 Participants
|
24 Participants
n=58 Participants
|
49 Participants
n=117 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
Asian
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
White
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
0 Participants
Race data was not collected..
|
|
Body mass index
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=59 Participants
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=58 Participants
|
28 kg/m^2
STANDARD_DEVIATION 4 • n=117 Participants
|
|
Smoking history
Yes
|
19 Participants
n=59 Participants
|
15 Participants
n=58 Participants
|
34 Participants
n=117 Participants
|
|
Smoking history
No
|
40 Participants
n=59 Participants
|
43 Participants
n=58 Participants
|
83 Participants
n=117 Participants
|
|
Diabetes history
Yes
|
6 Participants
n=59 Participants
|
12 Participants
n=58 Participants
|
18 Participants
n=117 Participants
|
|
Diabetes history
No
|
53 Participants
n=59 Participants
|
46 Participants
n=58 Participants
|
99 Participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 30 days after the procedureThe primary outcome was the Visual Analog Scale (VAS) pain score at 30-day follow-up visit, which was collected by patients marking a position on a strip to indicate the intensity of their pain. The locations patients marked are translated into a score from 0-100, with 0 being no pain and 100 corresponding to the worst imaginable pain.
Outcome measures
| Measure |
RFA at 90 Degrees Celsius
n=59 Participants
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
RFA at 80 Degrees Celsius
n=58 Participants
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
|---|---|---|
|
Visual Analog Scale (VAS) Pain Score 30-day After Procedure
|
50.4 units on a scale
Standard Deviation 31.4
|
47.2 units on a scale
Standard Deviation 30.5
|
Adverse Events
RFA at 90 Degrees Celsius
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RFA at 80 Degrees Celsius
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RFA at 90 Degrees Celsius
n=59 participants at risk
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 90 degrees Celsius
RFA at 90 degrees Celsius: Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
RFA at 80 Degrees Celsius
n=58 participants at risk
Radiofrequency ablation (RFA) of the lumbar facets nerve supply will be performed at 80 degrees Celsius
RFA at 80 degrees Celsius: Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
C-arm guided 20-gauge radiofrequency needle: Needles will be adjusted to optimize sensory and motor stimulation.
|
|---|---|---|
|
Surgical and medical procedures
Persistent Parethesia
|
0.00%
0/59 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
0.00%
0/58 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
|
Surgical and medical procedures
Nerve injuries
|
0.00%
0/59 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
0.00%
0/58 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
|
Surgical and medical procedures
Bleeding
|
0.00%
0/59 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
0.00%
0/58 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
|
Surgical and medical procedures
Infection
|
0.00%
0/59 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
0.00%
0/58 • Adverse events data were collected from the end of procedure to the 1-year follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place