Cryoneurolysis for Cutaneous Neuropathic Pain

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    25
  • sponsor
    Aarhus University Hospital
Updated on 14 June 2021
anesthesia
hyperalgesia

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.

Details
Condition Peripheral Neuropathy, Post-Surgical Pain, Pain, Neuralgia, Pain (Pediatric), neuropathic pain
Treatment Cryoneurolysis
Clinical Study IdentifierNCT04911569
SponsorAarhus University Hospital
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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