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Status unknownNCT04911569Updated Jun 3, 2021

Cryoneurolysis for Cutaneous Neuropathic Pain

An interventional study of Cryoneurolysis in Neuropathic Pain, sponsored by Aarhus University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-03.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neuropathic Pain

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 25 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Cryoneurolysis

    All 25 patients will receive cryoneurolysis

    Device: Cryoneurolysis

Interventions

  • DeviceCryoneurolysis

    Cryoneurolysis

06

What researchers measure

Primary outcomes

  1. Success of cryoneurolysis

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

    Time frame: 1 hour after cryoneurolysis

Secondary outcomes

  1. Axonal loss estimated before cryoneurolysis

    Time frame: Maximum one year prior to the cryoneurolysis procedure

  2. Hyperalgesia for pinprick

    Visual Analogue Scale (VAS) score (0-100)

    Time frame: 1 hour after cryo procedure compared to baseline

  3. Allodynia for brush

    VAS score (0-100)

    Time frame: 1 hour after cryo procedure compared to baseline

  4. Frequency of NRS score < 4

    Numeric Rating Scale (NRS) score (0-10)

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

  5. Pain score

    NRS score (0-10)

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

  6. Duration of freedom of pain (number of days after the cryoneurolysis procedure)

    NRS \< 4

    Time frame: Maximum follow-up until 12 months after cryoneurolysis procedure

  7. Change of neuropathic pain score DN-4

    DN-4 = Douleur Neuropathique en 4 Questions

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

  8. Patient satisfaction at completion of cryo procedure

    NRS score (0-10)

    Time frame: From skin insertion of cryo probe to withdrawal of cryo probe

  9. Change in muscle strength of relevant muscle groups

    Handheld dynamometer

    Time frame: 1 hour after cryoneurolysis compared to baseline

  10. Procedure time for cryoneurolysis

    Time frame: From skin insertion of cryo probe to withdrawal of cryo probe

  11. Pain related medication

    Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure

  12. PGIC

    Patient Global Impression of Change

    Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure

  13. Adverse events

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

07

Study locations

1 of 1 sites recruiting
  • Aarhus University Hospital
    Aarhus, Region Midtjylland 8000, Denmark
    • Thomas F Bendtsen, MD, PhD · Contact · tfb@dadlnet.dk · +4576484809
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04911569
Lead sponsor
Aarhus University Hospital
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
Jun 7, 2021 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Jun 3, 2021

Study contacts

Thomas F Bendtsen, MD, PhD
Contact
tfb@dadlnet.dk
+4576484809
Thomas F Bendtsen, MD, PhD
principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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