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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoneurolysis | Experimental | All 25 patients will receive cryoneurolysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoneurolysis | Device | Cryoneurolysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of cryoneurolysis | Frequency of patients with > 50% reduction of neuropathic pain | 1 hour after cryoneurolysis |
| Measure | Description | Time Frame |
|---|---|---|
| Axonal loss estimated before cryoneurolysis | Maximum one year prior to the cryoneurolysis procedure | |
| Hyperalgesia for pinprick | Visual Analogue Scale (VAS) score (0-100) | 1 hour after cryo procedure compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas F Bendtsen, MD, PhD | Contact | +4576484809 | tfb@dadlnet.dk |
| Name | Affiliation | Role |
|---|---|---|
| Thomas F Bendtsen, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Central Jutland | 8000 | Denmark |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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Non-blinded, non-randomized, non-controlled
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| Allodynia for brush | VAS score (0-100) | 1 hour after cryo procedure compared to baseline |
| 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 |
| Pain score | NRS score (0-10) | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure |
| Duration of freedom of pain (number of days after the cryoneurolysis procedure) | NRS < 4 | Maximum follow-up until 12 months after cryoneurolysis procedure |
| 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 |
| Patient satisfaction at completion of cryo procedure | NRS score (0-10) | From skin insertion of cryo probe to withdrawal of cryo probe |
| Change in muscle strength of relevant muscle groups | Handheld dynamometer | 1 hour after cryoneurolysis compared to baseline |
| Procedure time for cryoneurolysis | From skin insertion of cryo probe to withdrawal of cryo probe |
| Pain related medication | 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure |
| PGIC | Patient Global Impression of Change | 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure |
| Adverse events | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |