← Back to Search

Procedure

Cryoanalgesia for Phantom Limb Pain

N/A

Recruiting

Led By Brian 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

Experiencing at least moderate phantom limb pain-defined as a 4 or higher on the Numeric Rating Scale (NRS; 0-10, 0= no pain; 10=worst imaginable pain)-at least daily for the previous 2 months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 1

Awards & highlights

Study Summary

This trial will test if freezing nerves in amputees with intractable phantom limb pain can block bad signals to the brain and reverse abnormal changes that cause phantom pain.

Who is the study for?

This trial is for adults over 18 who have had an above-knee amputation at least 12 weeks ago and suffer from moderate to severe phantom limb pain daily. Participants should not change their pain medication or undergo elective surgeries from one month before until four months after the initial treatment.Check my eligibility

What is being tested?

The study tests cryoanalgesia, a prolonged nerve block achieved by freezing nerves, against a sham procedure to see if it can provide long-term relief from phantom limb pain in individuals with above-knee amputations. Each participant may receive both treatments over the course of the study.See study design

What are the potential side effects?

Potential side effects could include discomfort at the treatment site, temporary numbness or tingling, swelling, bruising, and skin changes due to cold exposure during cryoneurolysis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience daily phantom limb pain rated 4 or higher for the last 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average pain intensity change from baseline 1 month post-intervention

Secondary outcome measures

Average Daily Phantom Pain intensity change from baseline

Average Daily Residual Limb Pain intensity change from baseline

Brief Pain Inventory (interference sub scale), initial intervention

+29 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham Comparator first, then optional cryoneurolysis treatmentExperimental Treatment2 Interventions

Initial treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis. Optional active crossover treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis.

Group II: Cryoneurolysis first, then optional sham crossover treatmentExperimental Treatment2 Interventions

Initial treatment: Cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost with helium (Varian) or 2 cycles of 2-minute gas activation with an active probe separated by a 30-60 second defrost (Epimed). For active treatment, the gas will be deployed to the probe tip where a drop in temperature will result in cryoneurolysis. Optional sham crossover treatment: Sham cryoneurolysis of the major nerves of the thigh in the residual limb: The cryoneurolysis device will be triggered using 1 cycle of 5.5-minute argon activation followed by a 30-60 second defrost period with helium (Varian) or 2 cycles of 2-minute gas activation with a sham probe separated by a 30-60 second defrost (Epimed). However, for sham treatment, the gas is NOT deployed to the probe tip and therefore there is NO drop in temperature with NO resulting cryoneurolysis.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Epimed InternationalUNKNOWN

1 Previous Clinical Trials

99 Total Patients Enrolled

Varian Medical SystemsIndustry Sponsor

59 Previous Clinical Trials

3,759 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,521,024 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the current trial have open enrollment for participants?

"As reflected on clinicaltrials.gov, this medical experiment is currently recruiting participants. It was first advertised on October 1st 2023 and its most recent update also dates back to the same month of October in the year 2023."

Answered by AI

What is the number of individuals engaged in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment is presently accepting participants. It was originally published on October 1st 2023 and has been updated as recently as the same date. The trial is searching for a total of 20 patients from one centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation

Brian M. Ilfeld, MD, MS 2024. "Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071715.