Cryoneurolysis for Cutaneous Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911569
• Other study ID #: Cryo_210510_V02
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: Thomas F Bendtsen, MD, PhD
• Phone: +4576484809
• Email: tfb[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Cryoneurolysis
Cryoneurolysis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of cryoneurolysis	Frequency of patients with > 50% reduction of neuropathic pain	1 hour after cryoneurolysis
Secondary	Axonal loss estimated before cryoneurolysis		Maximum one year prior to the cryoneurolysis procedure
Secondary	Hyperalgesia for pinprick	Visual Analogue Scale (VAS) score (0-100)	1 hour after cryo procedure compared to baseline
Secondary	Allodynia for brush	VAS score (0-100)	1 hour after cryo procedure compared to baseline
Secondary	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
Secondary	Pain score	NRS score (0-10)	1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
Secondary	Duration of freedom of pain (number of days after the cryoneurolysis procedure)	NRS < 4	Maximum follow-up until 12 months after cryoneurolysis procedure
Secondary	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
Secondary	Patient satisfaction at completion of cryo procedure	NRS score (0-10)	From skin insertion of cryo probe to withdrawal of cryo probe
Secondary	Change in muscle strength of relevant muscle groups	Handheld dynamometer	1 hour after cryoneurolysis compared to baseline
Secondary	Procedure time for cryoneurolysis		From skin insertion of cryo probe to withdrawal of cryo probe
Secondary	Pain related medication		2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Secondary	PGIC	Patient Global Impression of Change	2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Secondary	Adverse events		1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure