Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Atlanta, Georgia 30322


Purpose:

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).


Study summary:

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 patient pain.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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.


NCT ID:

NCT02366832


Primary Contact:

Principal Investigator
John D Prologo, MD
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.