Cryoablation for Phantom Limb Pain

Completed · Not applicable

Conditions studied: Phantom Limb Syndrome

In brief

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).

Key facts

Study ID

NCT02366832

Run by

Emory University

People needed

23

Starts

2015-02-01

Expected to finish

2016-12-16

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 study
• Pregnant or planning to become pregnant
• Immunosuppression
• 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 of cryoablation.
• 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.

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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