Clinical trial NCT04911569: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-blinded, non-randomized, non-controlled
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Success of cryoneurolysis
timeFrame: 1 hour after cryoneurolysis
Secondary outcomes:
measure: Axonal loss estimated before cryoneurolysis
timeFrame: Maximum one year prior to the cryoneurolysis procedure
measure: Hyperalgesia for pinprick
timeFrame: 1 hour after cryo procedure compared to baseline
measure: Allodynia for brush
timeFrame: 1 hour after cryo procedure compared to baseline
measure: Frequency of NRS score < 4
timeFrame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
measure: Pain score
timeFrame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
measure: Duration of freedom of pain (number of days after the cryoneurolysis procedure)
timeFrame: Maximum follow-up until 12 months after cryoneurolysis procedure
measure: Change of neuropathic pain score DN-4
timeFrame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
measure: Patient satisfaction at completion of cryo procedure
timeFrame: From skin insertion of cryo probe to withdrawal of cryo probe
measure: Change in muscle strength of relevant muscle groups
timeFrame: 1 hour after cryoneurolysis compared to baseline
measure: Procedure time for cryoneurolysis
timeFrame: From skin insertion of cryo probe to withdrawal of cryo probe
measure: Pain related medication
timeFrame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
measure: PGIC
timeFrame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
measure: Adverse events
timeFrame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midtjylland
Study officials:
affiliation: Aarhus University Hospital
name: Thomas F Bendtsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: