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Cryoneurolysis for Cutaneous Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cryoneurolysis
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoneurolysis

Arm Description

All 25 patients will receive cryoneurolysis

Outcomes

Primary Outcome Measures

Success of cryoneurolysis
Frequency of patients with > 50% reduction of neuropathic pain

Secondary Outcome Measures

Axonal loss estimated before cryoneurolysis
Hyperalgesia for pinprick
Visual Analogue Scale (VAS) score (0-100)
Allodynia for brush
VAS score (0-100)
Frequency of NRS score < 4
Numeric Rating Scale (NRS) score (0-10)
Pain score
NRS score (0-10)
Duration of freedom of pain (number of days after the cryoneurolysis procedure)
NRS < 4
Change of neuropathic pain score DN-4
DN-4 = Douleur Neuropathique en 4 Questions
Patient satisfaction at completion of cryo procedure
NRS score (0-10)
Change in muscle strength of relevant muscle groups
Handheld dynamometer
Procedure time for cryoneurolysis
Pain related medication
PGIC
Patient Global Impression of Change
Adverse events

Full Information

First Posted
May 19, 2021
Last Updated
June 2, 2021
Sponsor
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04911569
Brief Title
Cryoneurolysis for Cutaneous Neuropathic Pain
Official Title
The Effect of Ultrasound-guided Cryoneurolysis on Persistent Cutaneous Neuropathic Pain After Surgery and Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 7, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-blinded, non-randomized, non-controlled
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryoneurolysis
Arm Type
Experimental
Arm Description
All 25 patients will receive cryoneurolysis
Intervention Type
Device
Intervention Name(s)
Cryoneurolysis
Intervention Description
Cryoneurolysis
Primary Outcome Measure Information:
Title
Success of cryoneurolysis
Description
Frequency of patients with > 50% reduction of neuropathic pain
Time Frame
1 hour after cryoneurolysis
Secondary Outcome Measure Information:
Title
Axonal loss estimated before cryoneurolysis
Time Frame
Maximum one year prior to the cryoneurolysis procedure
Title
Hyperalgesia for pinprick
Description
Visual Analogue Scale (VAS) score (0-100)
Time Frame
1 hour after cryo procedure compared to baseline
Title
Allodynia for brush
Description
VAS score (0-100)
Time Frame
1 hour after cryo procedure compared to baseline
Title
Frequency of NRS score < 4
Description
Numeric Rating Scale (NRS) score (0-10)
Time Frame
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Title
Pain score
Description
NRS score (0-10)
Time Frame
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
Title
Duration of freedom of pain (number of days after the cryoneurolysis procedure)
Description
NRS < 4
Time Frame
Maximum follow-up until 12 months after cryoneurolysis procedure
Title
Change of neuropathic pain score DN-4
Description
DN-4 = Douleur Neuropathique en 4 Questions
Time Frame
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Title
Patient satisfaction at completion of cryo procedure
Description
NRS score (0-10)
Time Frame
From skin insertion of cryo probe to withdrawal of cryo probe
Title
Change in muscle strength of relevant muscle groups
Description
Handheld dynamometer
Time Frame
1 hour after cryoneurolysis compared to baseline
Title
Procedure time for cryoneurolysis
Time Frame
From skin insertion of cryo probe to withdrawal of cryo probe
Title
Pain related medication
Time Frame
2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Title
PGIC
Description
Patient Global Impression of Change
Time Frame
2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Title
Adverse events
Time Frame
1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas F Bendtsen, MD, PhD
Phone
+4576484809
Email
tfb@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F Bendtsen, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas F Bendtsen, MD, PhD
Phone
+4576484809
Email
tfb@dadlnet.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Cryoneurolysis for Cutaneous Neuropathic Pain

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