Cryoablation for Phantom Limb Pain

• ClinicalTrials.gov Identifier: NCT02366832
• Recruitment Status: Completed
• First Posted: February 19, 2015
• Last Update Posted: March 22, 2017
• Sponsor: Emory University
• Collaborator: Boston Scientific Corporation
• Information provided by (Responsible Party): John Prologo, Emory University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Phantom Limb Syndrome	Procedure: Cryoablation; Device: 17g Galil Medical Ice Sphere cryoablation needle	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain
• Actual Study Start Date: February 2015
• Actual Primary Completion Date: December 16, 2016
• Actual Study Completion Date: December 16, 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: Cryoablation; Amputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation

Procedure: 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.; Other Names: Cryotherapy; Cryosurgery; Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully [ Time Frame: Post-Cryoablation ]
   Feasibility, defined by number of participants, in which cryoablation was performed successfully
2. Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs). [ Time Frame: 56 days ]
   Safety is measured by the number of subjects that had cryoablation procedure events (CPEs). CPEs are device- or procedure-related serious adverse events (SAE) or adverse events (AE) categorized as clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), nerve pain worsening, or toxicity of any kind (confusion, seizure).

Secondary Outcome Measures :

1. Change in pain scores on visual analogue scale (VAS ) [ Time Frame: Baseline, day 56 ]
   Change in pain score will be calculated by subtracting the day 56 pain score from the baseline pain score.The pain scores are on a continuous visual analogue scale of 0 to 100 mm. 0 mm = no pain and 100 mm = worst possible pain. The VAS is scored simply by measuring the distance, in mm, from the patient's mark to one of the ends of the line.
2. Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ) [ Time Frame: Baseline, day 56 ]
   Quality of life will be measured using Roland-Morris Disability Questionnaire (RDQ); it is a validated measure of physical disability due to low back pain.The best score is 0 (no disability) and worst is 24 (maximum disability).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Georgia

Emory University Hospital

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Boston Scientific Corporation

Investigators

• Principal Investigator: John D Prologo, MD; Emory University

More Information

Additional Information:

YouTube Video 

• Responsible Party: John Prologo, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02366832
• Other Study ID Numbers: IRB00078008
• First Posted: February 19, 2015
• Last Update Posted: March 22, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Phantom Limb; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain