Cryoablation for Phantom Limb Pain

NCT02366832 | Completed

• 1 other identifier: IRB00078008
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Phantom Limb Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in pain scores on visual analogue scale (VAS )

  Baseline, day 56

• Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)

  Baseline, day 56

Study Arms (1)

Cryoablation

EXPERIMENTAL

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

Procedure: Cryoablation; Device: 17g Galil Medical Ice Sphere cryoablation needle

Interventions

Cryoablation 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.

Also known as: Cryotherapy, Cryosurgery

Cryoablation

17g Galil Medical Ice Sphere cryoablation needle 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.

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Links

• YouTube Video

MeSH Terms

Conditions

Phantom Limb

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Study Officials

• John D Prologo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)