Back to results

Cryoablation for Phantom Limb Pain

Primary Purpose

Phantom Limb Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cryoablation

17g Galil Medical Ice Sphere cryoablation needle

About this trial

This is an interventional supportive care trial for Phantom Limb Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Emory University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation

Arm Description

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

Outcomes

Primary Outcome Measures

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

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).

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT02366832

First Posted

February 9, 2015

Last Updated

March 21, 2017

Sponsor

Emory University

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02366832

Brief Title

Cryoablation for Phantom Limb Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (Actual)

Primary Completion Date

December 16, 2016 (Actual)

Study Completion Date

December 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phantom Limb Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryoablation

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Cryoablation

Other Intervention Name(s)

Cryotherapy, Cryosurgery

Intervention Description

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

Device

Intervention Name(s)

17g Galil Medical Ice Sphere cryoablation needle

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully

Description

Feasibility, defined by number of participants, in which cryoablation was performed successfully

Time Frame

Post-Cryoablation

Title

Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).

Description

Time Frame

56 days

Secondary Outcome Measure Information:

Title

Change in pain scores on visual analogue scale (VAS )

Description

Time Frame

Baseline, day 56

Title

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

Description

Time Frame

Baseline, day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D Prologo, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Links:

URL

https://youtu.be/ORQKe7tTyFo

Description

YouTube Video

Learn more about this trial

Cryoablation for Phantom Limb Pain

We'll reach out to this number within 24 hrs