Your session is about to expire
← Back to Search
Other
Cryoablation for Rib Fracture Pain Control
N/A
Recruiting
Led By Joseph D Forrester, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients greater than 65 years with any acute rib fracture
Pain score equal to or greater than 5 with deep inspiration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is studying a long-term pain control method for elderly patients with rib fractures. The goal is to help them heal without complications and return to their normal level of function.
Who is the study for?
This trial is for elderly patients over 65 with acute rib fractures who experience significant pain (score of 5 or higher) when taking deep breaths. They must be admitted to Stanford Emergency Department and have no metastasis to ribs, severe coagulation issues, very low GCS scores, or specific rib fracture locations that make them unsuitable for the treatment.Check my eligibility
What is being tested?
The study is testing a procedure called cryoneurolysis against standard care in managing pain after rib fractures in elderly patients. The goal is to see if this technique can provide long-term relief and help patients return to their normal activities by minimizing complications.See study design
What are the potential side effects?
Potential side effects may include localized pain at the site of cryoablation, temporary numbness or tingling, skin changes like bruising or frostbite-like effects, and risks associated with cold therapy on nerves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 65 and have a recent rib fracture.
Select...
I experience significant pain when taking a deep breath.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Pain Assessed by Numeric Pain Score
Length of hospital stay
Secondary outcome measures
30-day mortality
30-day rib-specific readmission
Number of participants requiring ICU admission
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Image-guided percutaneous ICN (pICN): Group AExperimental Treatment1 Intervention
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to percutaneous image-guided cryoneurolysis (pICN) group within 72 hours of presentation.
Group II: Standard-of Care : Group BActive Control1 Intervention
Patients who were admitted after a traumatic injury, with rib fractures identified, who are >= 65 years of age will be randomized to standard-of-care group within 72 hours of presentation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoneurolysis
2018
N/A
~240
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,082 Total Patients Enrolled
5 Trials studying Rib Fractures
240 Patients Enrolled for Rib Fractures
Joseph D Forrester, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Rib Fractures
40 Patients Enrolled for Rib Fractures
Nishita Kothary, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only certain ribs (1, 2, 10, 11, 12) being broken will exclude you from participating.My rib fracture is close to my spine.Your Glasgow Coma Scale (GCS) score is less than 13, which means you may have severe brain injury or impairment.I am over 65 and have a recent rib fracture.I am undergoing spinal stabilization surgery.I experience significant pain when taking a deep breath.The doctor in charge may decide not to perform cryoablation for reasons that they think are not suitable for you.
Research Study Groups:
This trial has the following groups:- Group 1: Image-guided percutaneous ICN (pICN): Group A
- Group 2: Standard-of Care : Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants may enroll in this clinical trial?
"Confirmed. The information posted on the clinicaltrials.gov website shows that this research program is actively seeking participants, which began recruitment in June 2021 and was last modified in October 2022. 110 individuals are needed to join from a single medical site."
Answered by AI
What objectives are hoped to be achieved by this clinical experiment?
"This medical trial, which will be closely monitored for a duration of 12 months, has Length of hospital stay as its primary outcome. Secondary goals involve 30-day rib-specific readmission rate recorded via chart review after discharge, McGill Pain Questionnaire (MPQ) and Pain Rating Index (PRI) Scale Score administered by study/ clinical staff during patient discharge; in addition to the number of participants needing ICU admission being observed."
Answered by AI
Is recruitment for this investigation still open?
"Affirmative. Clinicaltrials.gov lists the trial as currently in progress with a first posting on June 1st 2021 and most recent edit on October 19th 2022. The study requires 110 patients from one site for participation."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger