Cryoneurolysis for Cutaneous Neuropathic Pain

June 2, 2021 updated by: Aarhus University Hospital

The Effect of Ultrasound-guided Cryoneurolysis on Persistent Cutaneous Neuropathic Pain After Surgery and Trauma

Feasibility study with 25 patients investigating the effect of cryoneurolysis on persistent cutaneous neuropathic pain after surgery and trauma. All patients receive active treatment (cryoneurolysis). The study design is unblinded, non-randomized, non-controlled.

Study Overview

Status

Status

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

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.
25

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.
  • Name: Thomas F Bendtsen, MD, PhD
  • Phone Number: +4576484809
  • Email: tfb@dadlnet.dk

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Thomas F Bendtsen, MD, PhD
          • Phone Number: +4576484809
          • Email: tfb@dadlnet.dk

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:

  • Age > 17 years
  • ASA (American Society of Anesthesiologists) physical status classification system I-III
  • Informed consent
  • Capable of subjective evaluation of pain
  • Capable of reading and understanding Danish and informed written consent
  • Average pain intensity >49/100 on VAS in the primary focal pain area for a minimum of 6 months at the time of inclusion
  • Relevant injury (surgery or trauma) of peripheral nerves
  • Plausible cutaneous location of pain
  • In the area of pain, at least one of the following (1-8): (1) Hypo/anesthesia for touch/brush (2) Hypo/anesthesia for cold (3) Hypo/anesthesia for warmth (4) Hypo/anesthesia for pinprick (5) Allodynia for touch/brush (6) Allodynia for cold (7) Allodynia for warmth (8) Hyperalgesia for pinprick
  • Neuropathic pain score (Douleur Neuropathique en 4 Questions, DN-4) >3/10
  • Definitive diagnosis of neuropathic pain (Finnerup et al 2016)

Exclusion Criteria:

  • Inability to cooperate
  • Inability to understand Danish
  • Allergy to local anesthetic
  • Infection in the area of cryo probe insertion
  • Significant competitive chronic pain
  • Progressive neurologic disease
  • Increased risk at needle insertion and cold exposure (e.g. Raynaud, coagulopathies)
  • Uncontrolled severe systemic disease
  • Implanted electronic devices unless approved by the relevant medical specialist
  • Previous cryoneurolysis with no relevant effect for the same neuropathic pain
  • Previous interventional pain therapy (e.g. spinal cord stimulation) with no relevant effect for the same neuropathic pain
  • Expected duration of life < 2 years
  • Pregnancy
  • Abuse of alcohol, narcotics or medicine
  • Current psychiatric disease
  • Inclusion in other clinical trials
  • Ongoing patient complaint
  • Body mass index < 18.5 or > 34.9 kg/m2
  • Change of pain therapy within the last 28 days prior to inclusion

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.
Experimental: Cryoneurolysis
All 25 patients will receive cryoneurolysis
Device: Cryoneurolysis
Cryoneurolysis

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
Success of cryoneurolysis
Time Frame: 1 hour after cryoneurolysis
Frequency of patients with > 50% reduction of neuropathic pain
1 hour after cryoneurolysis

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
Axonal loss estimated before cryoneurolysis
Time Frame: Maximum one year prior to the cryoneurolysis procedure
Maximum one year prior to the cryoneurolysis procedure
Hyperalgesia for pinprick
Time Frame: 1 hour after cryo procedure compared to baseline
Visual Analogue Scale (VAS) score (0-100)
1 hour after cryo procedure compared to baseline
Allodynia for brush
Time Frame: 1 hour after cryo procedure compared to baseline
VAS score (0-100)
1 hour after cryo procedure compared to baseline
Frequency of NRS score < 4
Time Frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Numeric Rating Scale (NRS) score (0-10)
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Pain score
Time Frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
NRS score (0-10)
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
Duration of freedom of pain (number of days after the cryoneurolysis procedure)
Time Frame: Maximum follow-up until 12 months after cryoneurolysis procedure
NRS < 4
Maximum follow-up until 12 months after cryoneurolysis procedure
Change of neuropathic pain score DN-4
Time Frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
DN-4 = Douleur Neuropathique en 4 Questions
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Patient satisfaction at completion of cryo procedure
Time Frame: From skin insertion of cryo probe to withdrawal of cryo probe
NRS score (0-10)
From skin insertion of cryo probe to withdrawal of cryo probe
Change in muscle strength of relevant muscle groups
Time Frame: 1 hour after cryoneurolysis compared to baseline
Handheld dynamometer
1 hour after cryoneurolysis compared to baseline
Procedure time for cryoneurolysis
Time Frame: From skin insertion of cryo probe to withdrawal of cryo probe
From skin insertion of cryo probe to withdrawal of cryo probe
Pain related medication
Time Frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
PGIC
Time Frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Patient Global Impression of Change
2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Adverse events
Time Frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure

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.
Aarhus University Hospital

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.
  • Principal Investigator: Thomas F Bendtsen, MD, PhD, Aarhus University Hospital

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 (Anticipated)

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.
June 7, 2021

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.
January 1, 2023

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, 2023

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).
May 19, 2021

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.
June 2, 2021

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.
June 3, 2021

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.
June 3, 2021

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.
June 2, 2021

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.
May 1, 2021

More Information

Terms related to this study

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.
  • Cryo_210510_V02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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