Neuropathic PainNCT04911569
Cryoneurolysis for Cutaneous Neuropathic Pain
A study testing Cryoneurolysis in people with Neuropathic Pain, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Cryoneurolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jun 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8000
Thomas F Bendtsen, MD, PhD, +4576484809, tfb@dadlnet.dk
About this study
Official title: The Effect of Ultrasound-guided Cryoneurolysis on Persistent Cutaneous Neuropathic Pain After Surgery and Trauma
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.
- Conditions
- Neuropathic Pain
- Being tested
- Cryoneurolysis
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisDevice
Cryoneurolysis
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis | Experimental | All 25 patients will receive cryoneurolysis Receives: Device: Cryoneurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of cryoneurolysis
Frequency of patients with > 50% reduction of neuropathic pain
Measured: 1 hour after cryoneurolysis
Secondary outcomes (13)
Axonal loss estimated before cryoneurolysis
Measured: Maximum one year prior to the cryoneurolysis procedure
Hyperalgesia for pinprick
Visual Analogue Scale (VAS) score (0-100)
Measured: 1 hour after cryo procedure compared to baseline
Allodynia for brush
VAS score (0-100)
Measured: 1 hour after cryo procedure compared to baseline
Frequency of NRS score < 4
Numeric Rating Scale (NRS) score (0-10)
Measured: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Pain score
NRS score (0-10)
Measured: 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
Measured: Maximum follow-up until 12 months after cryoneurolysis procedure
Change of neuropathic pain score DN-4
DN-4 = Douleur Neuropathique en 4 Questions
Measured: 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)
Measured: From skin insertion of cryo probe to withdrawal of cryo probe
Change in muscle strength of relevant muscle groups
Handheld dynamometer
Measured: 1 hour after cryoneurolysis compared to baseline
Procedure time for cryoneurolysis
Measured: From skin insertion of cryo probe to withdrawal of cryo probe
Pain related medication
Measured: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
PGIC
Patient Global Impression of Change
Measured: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Adverse events
Measured: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start7 Jun 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-blinded, non-randomized, non-controlled
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas F Bendtsen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911569
- Sponsor's protocol ID
- Cryo_210510_V02
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Cryoneurolysis on Persistent Cutaneous Neuropathic Pain After Surgery and Trauma
- ClinicalTrials.gov ID
- NCT04911569
- Acronym / sponsor ID
- Cryo_210510_V02
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-blinded, non-randomized, non-controlled
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis | Experimental | Device: CryoneurolysisAll 25 patients will receive cryoneurolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- Inability to cooperate
- Inability to understand Danish
- Allergy to local anesthetic
- Infection in the area of cryo probe insertion
- Significant competitive chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisCryoneurolysis | Device | Cryoneurolysis |
Primary outcome
Success of cryoneurolysis
Time frame: 1 hour after cryoneurolysis
Frequency of patients with > 50% reduction of neuropathic pain
13 secondary outcomes
Axonal loss estimated before cryoneurolysis
Time frame: Maximum one year prior to the cryoneurolysis procedure
Hyperalgesia for pinprick
Time frame: 1 hour after cryo procedure compared to baseline
Allodynia for brush
Time frame: 1 hour after cryo procedure compared to baseline
Frequency of NRS score < 4
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Pain score
Time frame: 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)
Time frame: Maximum follow-up until 12 months after cryoneurolysis procedure
Change of neuropathic pain score DN-4
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Patient satisfaction at completion of cryo procedure
Time frame: From skin insertion of cryo probe to withdrawal of cryo probe
Change in muscle strength of relevant muscle groups
Time frame: 1 hour after cryoneurolysis compared to baseline
Procedure time for cryoneurolysis
Time frame: From skin insertion of cryo probe to withdrawal of cryo probe
Pain related medication
Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
PGIC
Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Adverse events
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F Bendtsen, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurolysis in people with Neuropathic Pain, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas F Bendtsen, MD, PhD (+4576484809, tfb@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of cryoneurolysis (time frame: 1 hour after cryoneurolysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.