Cryoablation for Phantom Limb Pain

NCT ID: NCT02366832

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-12-16

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.

Conditions

Phantom Limb Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cryoablation

Amputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation

Group Type: EXPERIMENTAL

Cryoablation

Intervention Type: PROCEDURE

Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle.

17g Galil Medical Ice Sphere cryoablation needle

Intervention Type: DEVICE

Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained.

Interventions

Cryoablation

Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle.

Intervention Type: PROCEDURE

17g Galil Medical Ice Sphere cryoablation needle

Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained.

Intervention Type: DEVICE

Other Intervention Names

Cryotherapy; Cryosurgery

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

John Prologo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John D Prologo, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Related Links

https://youtu.be/ORQKe7tTyFo

YouTube Video

Other Identifiers

IRB00078008

Identifier Type: -

Identifier Source: org_study_id