Cryoablation for Phantom Limb Pain

Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain

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 Overview

• Status: Completed
• Conditions: Phantom Limb Syndrome
• Intervention / Treatment: Procedure: Cryoablation; Device: 17g Galil Medical Ice Sphere cryoablation needle

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully	Feasibility, defined by number of participants, in which cryoablation was performed successfully	Post-Cryoablation
Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).	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).	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores on visual analogue scale (VAS )	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.	Baseline, day 56
Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)	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).	Baseline, day 56

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: John D Prologo, MD, Emory University

Publications and helpful links

Helpful Links

• YouTube Video

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 16, 2016
• Study Completion (Actual): December 16, 2016

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: IRB00078008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No