Cryoablation for Phantom Limb Pain

Phantom Limb Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366832
• Other study ID #: IRB00078008
• Status: Completed
• Phase: N/A
• First received: February 9, 2015
• Last updated: March 21, 2017
• Start date: February 2015
• Est. completion date: December 16, 2016

Study information

• Verified date: March 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 16, 2016
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Galil Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

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