Trial Outcomes & Findings for Cryoneurolysis for Facet Mediated Chronic Low Back Pain (NCT NCT06016127)
NCT ID: NCT06016127
Last Updated: 2024-12-06
Results Overview
Safety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
0-12 months
Results posted on
2024-12-06
Participant Flow
Participant milestones
| Measure |
Cryoneurolysis
Subjects received iovera° cryoneurolysis to the medial branch nerves of the lumbar spine
iovera system: The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip will be used in this study.
|
Radiofrequency Ablation
Subjects received RFA to the medial branch nerves of the lumbar spine
Radiofrequency ablation: The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Cryoneurolysis
Subjects received iovera° cryoneurolysis to the medial branch nerves of the lumbar spine
iovera system: The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip will be used in this study.
|
Radiofrequency Ablation
Subjects received RFA to the medial branch nerves of the lumbar spine
Radiofrequency ablation: The RFA system consists of a Cosman, G4 Generator. The needles used are 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman, is placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
Cryoneurolysis for Facet Mediated Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Cryoneurolysis
n=15 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=15 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
NRS
|
6.1 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
ODI
|
18.5 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 5.9 • n=7 Participants
|
18.6 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsSafety will be assessed as the number of subjects with reported treatment-related adverse related to cryoneurolysis or RFA.
Outcome measures
| Measure |
Cryoneurolysis
n=11 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=12 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Safety of Cryoneurolysis as Compared to Radiofrequency Ablation (RFA)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Subjects who received the study intervention and completed 12-month study follow-up.
Subjects will evaluate their pain in the low back region using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain. Subjects will evaluate how much pain they are currently experiencing and their average pain level over the past 24 hours.
Outcome measures
| Measure |
Cryoneurolysis
n=11 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=12 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Pain Intensity as Measured by 11-point Numeric Rating Scale (NRS) at 12 Month Follow up
|
3.04 units on a scale
Standard Error 0.77
|
6.13 units on a scale
Standard Error 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-12 monthsFunction disability will be measured by the Oswestry Disability Index. The score ranges from 0-50, with lower scores reflecting milder disability.
Outcome measures
| Measure |
Cryoneurolysis
n=11 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=12 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Functional Disability Index at 12 Month Follow up
|
10.15 score on a scale
Interval 6.0 to 14.3
|
20.61 score on a scale
Interval 16.47 to 24.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsThe Patients' Global Impression of Change (PGIC) is an 11-point self-report scale assessing overall changes in activity limitations, symptoms, emotions, and quality of life, ranging from 0 to 10, where higher values indicate worse outcomes.
Outcome measures
| Measure |
Cryoneurolysis
n=11 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=12 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Patients' Global Impression of Change at 12 Month Follow up
|
1.74 score on a scale
Interval 0.7 to 2.77
|
4.38 score on a scale
Interval 3.34 to 5.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Subjects who received the study intervention and completed the 12-month follow-up.
Subject satisfaction with pain management as measured on a scale ranging from 1) extremely dissatisfied 2) dissatisfied 3) neither satisfied nor dissatisfied 4) satisfied 5) extremely satisfied.
Outcome measures
| Measure |
Cryoneurolysis
n=11 Participants
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=12 Participants
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Satisfaction With Pain Management
Dissatisfied
|
0 participants
|
0 participants
|
|
Satisfaction With Pain Management
Neither satisfied nor dissatisfied
|
1 participants
|
4 participants
|
|
Satisfaction With Pain Management
Satisfied
|
10 participants
|
8 participants
|
Adverse Events
Cryoneurolysis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Radiofrequency Ablation
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 |
Cryoneurolysis
n=15 participants at risk
The iovera° system consists of a reusable, portable Handpiece, along with single patient use sterile Smart Tips (i.e., cryoprobes) and disposable nitrous oxide (N2O) cartridges. The iovera° system produces the desired effect through initiation of a cooling cycle. Each cooling cycle is initiated by fully inserting the Smart Tip into the selected procedure site and activating the cryogen flow. The Smart Tip needles are made of stainless steel and have a closed tip, fully enclosing the cryogen. The "190" Smart Tip was used in this study.
|
Radiofrequency Ablation
n=15 participants at risk
The RFA system consisted of a Cosman, G4 Generator. The needles used were 20-gauge, 10cm long with a 10mm active tip manufactured by Cosman. A grounding pad, also manufactured by Cosman was placed on the upper thigh for each procedure and connected to the G4 Generator.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
Additional Information
Kasandra Cliff
Albany Saratoga Centers for Pain Management
Phone: 518-371-6772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place