Clinical trial NCT02366832: Cryoablation for Phantom Limb Pain
Official title: Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Syndrome
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2015-02-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully
timeFrame: Post-Cryoablation
measure: Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).
timeFrame: 56 days
Secondary outcomes:
measure: Change in pain scores on visual analogue scale (VAS )
timeFrame: Baseline, day 56
measure: Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)
timeFrame: Baseline, day 56
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: John D Prologo, MD
role: PRINCIPAL_INVESTIGATOR
References: