Status:
UNKNOWN
Cryoneurolysis for Cutaneous Neuropathic Pain
Lead Sponsor:
Aarhus University Hospital
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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)....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04911569
Start Date
June 7 2021
End Date
January 1 2023
Last Update
June 3 2021
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8000