NCT04911569

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

May 19, 2021

Last Update Submit

June 2, 2021

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Success of cryoneurolysis

    Frequency of patients with \> 50% reduction of neuropathic pain

    1 hour after cryoneurolysis

Secondary Outcomes (13)

  • Axonal loss estimated before cryoneurolysis

    Maximum one year prior to the cryoneurolysis procedure

  • Hyperalgesia for pinprick

    1 hour after cryo procedure compared to baseline

  • Allodynia for brush

    1 hour after cryo procedure compared to baseline

  • Frequency of NRS score < 4

    1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure

  • Pain score

    1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure

  • +8 more secondary outcomes

Study Arms (1)

Cryoneurolysis

EXPERIMENTAL

All 25 patients will receive cryoneurolysis

Device: Cryoneurolysis

Interventions

CryoneurolysisDEVICE

Cryoneurolysis

Cryoneurolysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas F Bendtsen, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas F Bendtsen, MD, PhD

CONTACT

+4576484809tfb@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Non-blinded, non-randomized, non-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 3, 2021

Study Start

June 7, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)