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Cryoneurolysis first, then optional sham crossover treatment for Phantom Limb Pain

N/A
Waitlist Available
Led By Brian M Ilfeld, MD, MS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4 months later (difference between the two is the primary end point)
Awards & highlights

Summary

This trial is testing whether freezing the nerve where an amputation occurred can help with phantom limb pain.

Eligible Conditions
  • Phantom Limb Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 4 months after the initial and crossover treatments as well as 12 months after the initial treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 4 months after the initial and crossover treatments as well as 12 months after the initial treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Average Daily Phantom Pain Intensity
Secondary outcome measures
Average Daily Phantom Pain Intensity
Beck Depression Inventory
Brief Pain Inventory Interference Subscale
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cryoneurolysis first, then optional sham crossover treatmentActive Control2 Interventions
Initial treatment: Cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis. Optional sham crossover treatment: Sham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis.
Group II: Sham Comparator first, then optional cryoneurolysis treatmentPlacebo Group2 Interventions
Initial treatment: Sham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis. Optional cryoneurolysis treatment: Cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,157 Previous Clinical Trials
1,571,275 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,334 Total Patients Enrolled
Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity California San Diego Department of Anesthesiology
20 Previous Clinical Trials
1,516 Total Patients Enrolled
~19 spots leftby Sep 2025
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