Cryoablation for Phantom Limb Pain
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|ClinicalTrials.gov Identifier: NCT02366832|
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : March 22, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Syndrome||Procedure: Cryoablation Device: 17g Galil Medical Ice Sphere cryoablation needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|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|
Amputee subjects experiencing phantom limb syndrome (PLS) will receive 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.
- 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
- 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).
- 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.
- 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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366832
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||John D Prologo, MD||Emory University|
|Responsible Party:||John Prologo, Assistant Professor, Emory University|
|Other Study ID Numbers:||
|First Posted:||February 19, 2015 Key Record Dates|
|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|
Nervous System Diseases