Phantom Limb SyndromeNCT02366832
Cryoablation for Phantom Limb Pain
A study testing Cryoablation and 17g Galil Medical Ice Sphere cryoablation needle in people with Phantom Limb Syndrome, run by Emory University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Syndrome
- What is being tested?
- Cryoablation and 17g Galil Medical Ice Sphere cryoablation needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 16 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Phantom Limb Syndrome
- Being tested
- Cryoablation, 17g Galil Medical Ice Sphere cryoablation needle
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Also called Cryotherapy, Cryosurgery
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.
17g Galil Medical Ice Sphere cryoablation needleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Experimental | Amputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation Receives: Procedure: Cryoablation; Device: 17g Galil Medical Ice Sphere cryoablation needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 56 days
Secondary outcomes (2)
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.
Measured: 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).
Measured: Baseline, day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb SyndromeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, John Prologo, Emory University
- Investigators
- John D Prologo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366832
- Sponsor's protocol ID
- IRB00078008
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT02366832
- Acronym / sponsor ID
- IRB00078008
- Conditions
- Phantom Limb Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2015 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Procedure: Cryoablation, Device: 17g Galil Medical Ice Sphere cryoablation needleAmputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationAlso: Cryotherapy, CryosurgerySubjects 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. | Procedure or surgery | Cryoablation |
| 17g Galil Medical Ice Sphere cryoablation needleUnder 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. | Device | Cryoablation |
Primary outcome
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).
2 secondary outcomes
Change in pain scores on visual analogue scale (VAS )
Time frame: Baseline, day 56
Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)
Time frame: Baseline, day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- YouTube VideoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Phantom Limb Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Prologo, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and 17g Galil Medical Ice Sphere cryoablation needle in people with Phantom Limb Syndrome, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully (time frame: Post-Cryoablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.