Cryolesion in Treatment of Phantom Limb Pain

September 21, 2018 updated by: Dariusz Tomaszewski, Military Institute of Medicine, Poland

Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jaroslaw J Les, MD PhD
  • Phone Number: 00 48 695 926 026
  • Email: jles@wim.mil.pl

Study Locations

  • Poland
      • Warsaw, Poland, 04141
        • Recruiting
        • Military Institute of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: cryoablation
peripheral nerve cryoablation
Procedure: cryoablation
cryoablation of nerve responsible for phantom limb pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of pain
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.

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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The quality of life (SF-36)
Time Frame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.

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).
A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
The quality of life (AIS)
Time Frame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
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.
A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Military Institute of Medicine, Poland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dariusz Tomaszewski, Military Institute of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 681006-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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