Status:
COMPLETED
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
United States Department of Defense
Conditions:
Post-Amputation Phantom Limb Pain
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
- with a lower limb traumatic or surgical amputation at least 12 weeks prior to enrollment distal to the hip (femoral head remaining)
- who experience at least moderate phantom limb pain-defined as a 3 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.
- accepting of a cryoneurolysis procedure
- 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 :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03449667
Start Date
March 23 2018
End Date
March 17 2022
Last Update
February 17 2023
Active Locations (6)
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1
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
University California San Diego
San Diego, California, United States, 92103
3
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
4
University of Florida
Gainesville, Florida, United States, 32610