Trial Outcomes & Findings for Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis (NCT NCT05330611)
NCT ID: NCT05330611
Last Updated: 2026-04-24
Results Overview
Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Daily numeric pain score is collected on the day the patient is discharged from the hospital.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
At time of discharge from hospital (up to 1 month)
Results posted on
2026-04-24
Participant Flow
Patients were pre-screened by research staff to determine if the inclusion criteria were met and then discussed with investigators. If investigators approved them, they were approached by research staff for in-person consent at Stanford Healthcare (SHC).
Participant milestones
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Baseline
STARTED
|
24
|
19
|
|
Baseline
COMPLETED
|
21
|
19
|
|
Baseline
NOT COMPLETED
|
3
|
0
|
|
1-month follow-up
STARTED
|
21
|
19
|
|
1-month follow-up
COMPLETED
|
16
|
15
|
|
1-month follow-up
NOT COMPLETED
|
5
|
4
|
|
3-month follow-up
STARTED
|
21
|
18
|
|
3-month follow-up
COMPLETED
|
14
|
12
|
|
3-month follow-up
NOT COMPLETED
|
7
|
6
|
|
12-month follow-up
STARTED
|
21
|
18
|
|
12-month follow-up
COMPLETED
|
9
|
9
|
|
12-month follow-up
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Baseline
Screen failure
|
3
|
0
|
|
1-month follow-up
Lost to Follow-up
|
5
|
3
|
|
1-month follow-up
Incarcerated
|
0
|
1
|
|
3-month follow-up
Lost to Follow-up
|
7
|
6
|
|
12-month follow-up
Incarcerated
|
1
|
0
|
|
12-month follow-up
Lost to Follow-up
|
10
|
9
|
|
12-month follow-up
Death
|
1
|
0
|
Baseline Characteristics
Treatment of Adult Traumatic Rib Fractures With Percutaneous Cryoneurolysis
Baseline characteristics by cohort
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
|
Standard-of-Care : Group B
n=19 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=2 Participants
|
53 years
n=1 Participants
|
53 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=2 Participants
|
15 Participants
n=1 Participants
|
31 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=2 Participants
|
12 Participants
n=1 Participants
|
23 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
|
Highest pain score in first 24 hours
|
8.76 score on a scale
STANDARD_DEVIATION 1.34 • n=2 Participants
|
8.26 score on a scale
STANDARD_DEVIATION 1.28 • n=1 Participants
|
8.53 score on a scale
STANDARD_DEVIATION 1.32 • n=3 Participants
|
|
Daily opioid equivalents before intervention
|
96.5 MME/day
n=2 Participants
|
42.63 MME/day
n=1 Participants
|
59 MME/day
n=3 Participants
|
PRIMARY outcome
Timeframe: At time of discharge from hospital (up to 1 month)Patients will be asked to verbalize their numeric pain score, measured on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain. Daily numeric pain score is collected on the day the patient is discharged from the hospital.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=19 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Daily Numeric Pain Score
|
7.48 score on a scale
Standard Deviation 2.11
|
6.47 score on a scale
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Collected at discharge (up to 1 month), 1, 3, 12 months post dischargePopulation: Participants with MME values recorded in their charts at each time point were analyzed.
Morphine Milligram Equivalents (MME)
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=19 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Daily Narcotic Equivalents
Discharge
|
60 MME/day
Interval 15.65 to 94.5
|
15 MME/day
Interval 0.0 to 60.0
|
|
Daily Narcotic Equivalents
1-month follow-up
|
0 MME/day
Interval 0.0 to 10.0
|
0 MME/day
Interval 0.0 to 0.0
|
|
Daily Narcotic Equivalents
3-month follow-up
|
0 MME/day
Interval 0.0 to 0.0
|
0 MME/day
Interval 0.0 to 0.0
|
|
Daily Narcotic Equivalents
12-month follow-up
|
0 MME/day
Interval 0.0 to 0.0
|
0 MME/day
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargePopulation: All participants with available data were analyzed.
Number of patients who died within 30 days of discharge, obtained from chart review.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=20 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=18 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Number of Patients With 30-day Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargeWill be obtained from chart review after discharge
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=19 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Need for ICU Admission
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 month after hospital dischargePopulation: Participants with available data were analyzed.
Patients with at least one rib-specific readmission (delayed hemothorax, pneumothorax, pneumonia, pain) within 30 days of discharge
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=18 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Number of Patients With a 30-day Rib-specific Admission
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Collected 1, 3, 12 months (post hospital discharge)Population: The analysis population includes everyone who has at least 1 McGill score reported at any follow-up timepoint. Since follow-up was conducted by phone and the McGill visual analogue scale requires an in-person assessment, no patients had a visual analogue score.
The McGill Pain Questionnaire (MPQ) is a validated 20 question instrument to quantify subjective pain and the scoring system yields a Pain Rating Index (PRI) score between Mild, Moderate or Severe. The questionnaire will be administered to the patient by study/clinical staff during follow up. Using these questionnaires, McGill Present Pain Intensity (PPI), Sensory, Affective, and Visual Analogue Scale (VAS) sub scores will be calculated and reported. PPI and Visual Analogue Scale scores are on a scale of 0-10, Sensory scores are on a scale of 0-33, and Affective scores are on a scale of 0-12. For all McGill pain scores, a higher score indicates a worse outcome.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
PPI at 1-month follow-up
|
3.19 scores on a scale
Standard Deviation 2.69
|
2.07 scores on a scale
Standard Deviation 2.25
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Sensory at 3-month follow-up
|
1.64 scores on a scale
Standard Deviation 2.27
|
0.75 scores on a scale
Standard Deviation 1.22
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Sensory at 1-month follow-up
|
2.19 scores on a scale
Standard Deviation 1.60
|
1.53 scores on a scale
Standard Deviation 1.68
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Affective at 1-month follow-up
|
0.19 scores on a scale
Standard Deviation 0.54
|
0 scores on a scale
Standard Deviation 0
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
PPI at 3-month follow-up
|
2.07 scores on a scale
Standard Deviation 2.76
|
0.92 scores on a scale
Standard Deviation 1.51
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Affective at 3-month follow-up
|
0.50 scores on a scale
Standard Deviation 1.87
|
0 scores on a scale
Standard Deviation 0
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
PPI at 12-month follow-up
|
0.67 scores on a scale
Standard Deviation 1.00
|
0.67 scores on a scale
Standard Deviation 1.32
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Sensory at 12-month follow-up
|
0.56 scores on a scale
Standard Deviation 1.33
|
0.22 scores on a scale
Standard Deviation 0.67
|
|
The McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Sub Scores
Affective at 12-month follow-up
|
0 scores on a scale
Standard Deviation 0
|
0.11 scores on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Collected 1, 3, 12 months post hospital dischargePopulation: Participants who had GOS-E data at any follow-up time point are included. Deaths were not included.
The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category: 1. Death (D) 2. Vegetative state (VS) 3. Lower severe disability (SD -) 4. Upper severe disability (SD +) 5. Lower moderate disability ( MD -) 6. Upper moderate disability ( MD +) 7. Lower good recovery (GR -) 8. Upper good recovery (GR +) The questionnaire will be administered to the patient by study/clinical staff during follow up.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · MD+
|
1 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · SD-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · SD-
|
1 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · MD-
|
8 Participants
|
5 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · GR-
|
2 Participants
|
3 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
1-month follow-up · GR+
|
4 Participants
|
5 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · MD-
|
3 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · MD+
|
3 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · GR-
|
1 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
3-month follow-up · GR+
|
7 Participants
|
8 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · SD-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · MD-
|
1 Participants
|
2 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · MD+
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · GR-
|
0 Participants
|
0 Participants
|
|
The Glasgow Outcome Scale Extended (GOS-E) Score
12-month follow-up · GR+
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Collected 1, 3, 12 months (post hospital discharge)Population: Participants with available SF-12 scores at any follow-up time point were included.
The 12-Item Short-Form Health Survey is a widely used composite score used to gauge overall health. The composite score is based on 8 domains scores contained in the SF-12 questionnaire, which will be administered to the patient by study/clinical staff during follow up. The composite score is split into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Both PCS and MCS are standardized scores on a 0-100 scale based on the US population, with a mean of 50 and a standard deviation of 10. Higher PCS or MCS scores indicate better health, while lower scores indicate worse health.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=17 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 PCS at 1-month follow-up
|
34.28 scores on a scale
Interval 23.01 to 42.3
|
32.04 scores on a scale
Interval 24.72 to 49.98
|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 MCS at 1-month follow-up
|
53.60 scores on a scale
Interval 48.08 to 57.38
|
51.74 scores on a scale
Interval 49.41 to 57.72
|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 PCS at 3-month follow-up
|
40.89 scores on a scale
Interval 28.38 to 54.18
|
54.55 scores on a scale
Interval 39.21 to 57.13
|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 MCS at 3-month follow-up
|
56.01 scores on a scale
Interval 47.1 to 59.59
|
51.82 scores on a scale
Interval 50.36 to 54.29
|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 PCS at 12-month follow-up
|
52.77 scores on a scale
Interval 40.7 to 55.19
|
53.13 scores on a scale
Interval 47.89 to 55.73
|
|
Short Form (SF-12) Health Survey Scale Summary Scores
SF-12 MCS at 12-month follow-up
|
59.26 scores on a scale
Interval 52.51 to 61.15
|
53.47 scores on a scale
Interval 49.4 to 55.87
|
SECONDARY outcome
Timeframe: Up to 1 month from ED arrivalThe length of hospital stay will be obtained from the patient's chart after discharge.
Outcome measures
| Measure |
Ultrasound-guided Cryoneurolysis: Group A
n=21 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Standard-of-Care : Group B
n=19 Participants
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Length of Hospital Stay
|
4 days
Interval 3.0 to 7.0
|
3 days
Interval 2.0 to 4.0
|
Adverse Events
Standard-of-Care : Group B
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Ultrasound-guided Cryoneurolysis: Group A
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard-of-Care : Group B
n=19 participants at risk
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Ultrasound-guided Cryoneurolysis: Group A
n=21 participants at risk
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
General disorders
Readmission for Polytrauma Injury Follow Up
|
21.1%
4/19 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
14.3%
3/21 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
|
Respiratory, thoracic and mediastinal disorders
Chest Wall Related Readmission
|
0.00%
0/19 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
9.5%
2/21 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
Other adverse events
| Measure |
Standard-of-Care : Group B
n=19 participants at risk
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to Standard of Care which typically includes multi-modal pain therapy and pulmonary toilet.
Standard of Care: Patients will be provided regular standard of care at the Stanford Hospital with short- or long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
Standard of care for patients with rib fractures that are not eligible for surgical stabilization includes multi-modal pain therapy and pulmonary toilet.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
Ultrasound-guided Cryoneurolysis: Group A
n=21 participants at risk
Patients who are admitted to the Emergency Department after a traumatic injury. Patients will have rib fractures in any of ribs 3-9. Patients will be 18-64 years of age and will be randomized (1:1) to the ultrasound-guided cryoneurolysis group within 72 hours of admission to the ED.
Intervention is ultrasound-guided cryoneurolysis of intercostal nerves creating lost lasting pain relief. Device used for cryoneurolysis is Iovera Smart tip 190
Cryoneurolysis of Intercostal Nerves: Patients will be offered a minimally invasive intervention procedure for pain control called cryoneurolysis using an ultrasound-guided device called the Iovera Smart Tip 190.
The direct application of cold to the intercostal nerves via Iovera device produces lesions in peripheral nervous tissue to block the pain caused by rib fractures.
This procedure is particularly beneficial for patients who are not candidates for surgical stabilization of their rib fractures.
Application of cryoneurolysis as an analgesic will reduce the amount of narcotics patients might need and instead provide them short- or long-term pain control with minimal risk.
Follow up includes pain surveys administered in Chest Wall clinic or via telephone at 30, 90, 365 days post discharge.
|
|---|---|---|
|
Cardiac disorders
Tachycardia and atrial fibrillation
|
5.3%
1/19 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
9.5%
2/21 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Adverse Events
|
15.8%
3/19 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
19.0%
4/21 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
|
Gastrointestinal disorders
Gastrointestinal AEs
|
5.3%
1/19 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
4.8%
1/21 • From inpatient enrollment in trial until the end of follow-up, 12 months later
Prospective and retrospective
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place