Status:
COMPLETED
Cryoanalgesia to Treat Phantom Limb Pain Following Above-Knee Amputation
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Amputation, Surgical
Amputation, Traumatic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted in...
Detailed Description
Subjects will be asked to make no changes to their analgesic regimen for at least 1 month prior to the cryoneurolysis procedure and continuing for 4 months until the measurement of the primary end poi...
Eligibility Criteria
Inclusion
- Adult patients of at least 18 years of age
- Trans-femoral traumatic or surgical amputation at least 12 weeks prior to enrollment distal to the hip (femoral head remaining)
- 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
- willing to avoid both changes to their analgesic regimen as well as elective surgical procedures from 1 month prior to and at least 4 months following the initial cryoneurolysis procedure.
Exclusion
- allergy to amide local anesthetics
- pregnancy
- incarceration
- inability to communicate with the investigators
- morbid obesity (body mass index \> 40 kg/m2)
- possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06071715
Start Date
February 12 2024
End Date
October 9 2025
Last Update
October 20 2025
Active Locations (1)
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1
University of California San Diego
La Jolla, California, United States, 92037