Cryoneurolysis for Cutaneous Neuropathic Pain

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: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: Cryoneurolysis

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryoneurolysis; All 25 patients will receive cryoneurolysis	Device: Cryoneurolysis; Cryoneurolysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 7, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID 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