Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2021-06-07
2023-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cryoneurolysis
All 25 patients will receive cryoneurolysis
Cryoneurolysis
Cryoneurolysis
Interventions
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Cryoneurolysis
Cryoneurolysis
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Principal Investigators
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Thomas F Bendtsen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Cryo_210510_V02
Identifier Type: -
Identifier Source: org_study_id
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