Neuropathic Pain
Conditions
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.
Interventions
DEVICECryoneurolysis
Cryoneurolysis
Sponsors
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-blinded, non-randomized, non-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of cryoneurolysis | 1 hour after cryoneurolysis | Frequency of patients with \> 50% reduction of neuropathic pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperalgesia for pinprick | 1 hour after cryo procedure compared to baseline | Visual Analogue Scale (VAS) score (0-100) |
| Allodynia for brush | 1 hour after cryo procedure compared to baseline | VAS score (0-100) |
| Frequency of NRS score < 4 | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure | Numeric Rating Scale (NRS) score (0-10) |
| Pain score | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure | NRS score (0-10) |
| Duration of freedom of pain (number of days after the cryoneurolysis procedure) | Maximum follow-up until 12 months after cryoneurolysis procedure | NRS \< 4 |
| Change of neuropathic pain score DN-4 | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure | DN-4 = Douleur Neuropathique en 4 Questions |
| Axonal loss estimated before cryoneurolysis | Maximum one year prior to the cryoneurolysis procedure | — |
| Change in muscle strength of relevant muscle groups | 1 hour after cryoneurolysis compared to baseline | Handheld dynamometer |
| 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 | 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure | Patient Global Impression of Change |
| Adverse events | 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure | — |
| Patient satisfaction at completion of cryo procedure | From skin insertion of cryo probe to withdrawal of cryo probe | NRS score (0-10) |
Countries
Denmark
Contacts
Primary ContactThomas F Bendtsen, MD, PhD
Outcome results
None listed