The purpose of this study is to determine if treatment with percutaneous cryoablation yields
significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).
This study aims to treat Phantom Limb Syndrome (PLS) with cryoablation of the remaining
nerve stumps. The rationale is that because the pain in PLS follows the known distribution
of nerves, and because the amputated nerves are known to undergo changes after the surgery
that may lead to excessive "firing," that interruption of the nerve impulses will reduce
- Subjects are status post (s/p) amputation of an upper or lower limb. That is, the
amputation is not congenital.
- Refractory pain symptoms, following tissue healing(postoperatively, or post injury)
are related to amputation as determined by referring physician and investigator, to
include: stump pain, phantom pain, unpleasant phantom sensations, and/or undesirable
and/or life-limiting kinesthetic sensations. The character, frequency, location,
description, and exacerbation or relieving elements will be recorded.
Patients will be questioned as to the location of their sensation, be it pain, movement,
burning, tingling, or other. The location of their pain will be correlated with the
corresponding proximal nerve stump.
- Positive anesthetic/steroid block, as performed under CT guidance in an analogous
fashion to the cryoablation procedure.
- Absence of infection
- Absence of coagulopathy
- Ability and willingness of patient to provide written informed consent
- Active infection
- Underlying congenital segmentation or other spinal anomalies that result in
differential nerve root pressures
- Significant spinal stenosis interpreted as "severe" on any cross sectional imaging
- Pregnant or planning to become pregnant
- History or laboratory results indicative of any significant cardiac, endocrine,
hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary,
gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder
that in the opinion of the Principal Investigator would preclude the safe performance
- Uncorrectable coagulopathies
- Concurrent participation in another investigational trial involving systemic
administration of agents or within the previous 30 days.
- Have undergone a previous surgical intervention - post amputation - that may have
altered the target nerve.