Cryolesion in Treatment of Phantom Limb Pain
Primary Purpose
Phantom Limb Pain, Stump Neuralgia, Pain, Phantom
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cryoablation
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring cryoablation
Eligibility Criteria
Inclusion Criteria:
- Status post amputation of a lower or upper limb
- Pain related to amputation as determined by referring physician and investigator
- Informed consent of patient to enter the study
- Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure
Exclusion Criteria:
- Pregnancy
- Active infection in the area of the planned intervention
- Blood coagulation disorders
- Immunosuppression
- Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
- Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
- Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
- No reduction of pain after the diagnostic block of the relevant main peripheral nerves
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cryoablation
Arm Description
peripheral nerve cryoablation
Outcomes
Primary Outcome Measures
Reduction of pain
Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale).
Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from '0' (minimum, "no pain") to '10' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.
Secondary Outcome Measures
The quality of life (SF-36)
Assessment of the quality of life pre- and post - cryoablation on SF-36. 36-Item Short Form Survey (SF-36) is a 36-item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).
The quality of life (AIS)
Assessment of the quality of life pre- and post - cryoablation on AIS. The Acceptance of Illness Scale (AIS) consists of eight statements describing negative impact of poor health status and its consequences for patients' functioning. The scoring for each statement varies from 1 (poor adaptation to the disease) to 5 (full acceptance of the disease). The total score ranges between 8 and 40. The lower score, the poorer acceptance of disease and more severe restrictions caused by condition. A high score means acceptance of patient's own health status and lack of negative emotions related to illness.
Full Information
NCT ID
NCT03415360
First Posted
January 13, 2018
Last Updated
September 21, 2018
Sponsor
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03415360
Brief Title
Cryolesion in Treatment of Phantom Limb Pain
Official Title
Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Institute od Medicine National Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.
Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.
Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.
24 hours after the procedure - assessment of pain intensity and quality of life
7 days after the procedure - assessment of pain intensity
30 days after the procedure - assessment of pain intensity and quality of life
3 months after the procedure - assessment of pain intensity
6 months after the procedure - assessment of pain intensity and quality of
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Stump Neuralgia, Pain, Phantom
Keywords
cryoablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryoablation
Arm Type
Other
Arm Description
peripheral nerve cryoablation
Intervention Type
Procedure
Intervention Name(s)
cryoablation
Intervention Description
cryoablation of nerve responsible for phantom limb pain
Primary Outcome Measure Information:
Title
Reduction of pain
Description
Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale).
Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from '0' (minimum, "no pain") to '10' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.
Time Frame
T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.
Secondary Outcome Measure Information:
Title
The quality of life (SF-36)
Description
Assessment of the quality of life pre- and post - cryoablation on SF-36. 36-Item Short Form Survey (SF-36) is a 36-item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).
Time Frame
A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
Title
The quality of life (AIS)
Description
Assessment of the quality of life pre- and post - cryoablation on AIS. The Acceptance of Illness Scale (AIS) consists of eight statements describing negative impact of poor health status and its consequences for patients' functioning. The scoring for each statement varies from 1 (poor adaptation to the disease) to 5 (full acceptance of the disease). The total score ranges between 8 and 40. The lower score, the poorer acceptance of disease and more severe restrictions caused by condition. A high score means acceptance of patient's own health status and lack of negative emotions related to illness.
Time Frame
A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Status post amputation of a lower or upper limb
Pain related to amputation as determined by referring physician and investigator
Informed consent of patient to enter the study
Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure
Exclusion Criteria:
Pregnancy
Active infection in the area of the planned intervention
Blood coagulation disorders
Immunosuppression
Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
No reduction of pain after the diagnostic block of the relevant main peripheral nerves
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dariusz Tomaszewski, MD PhD
Phone
00 48501 190 386
Email
dtomaszewski@wim.mil.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Jaroslaw J Les, MD PhD
Phone
00 48 695 926 026
Email
jles@wim.mil.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariusz Tomaszewski
Organizational Affiliation
Military Institute of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
ZIP/Postal Code
04141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Les, MD, PhD
Phone
+48 216816895
Email
jles@wim.mil.pl
12. IPD Sharing Statement
Learn more about this trial
Cryolesion in Treatment of Phantom Limb Pain
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