To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.
Diagnosis of chronic pain (generally pain duration of at least 3-6 months) localized to an anatomical region appropriate for cryoneurolysis as determined by the treating physician.
Planned cryoneurolysis procedure as part of standard clinical care.
Ability to provide written informed consent.
Ability and willingness to complete baseline and follow-up questionnaires.
Cryoneurolysis performed as part of a separate investigational trial in which data sharing is not permitted.
Active infection or other clinical contraindication to the procedure as determined by the treating clinician.
Life expectancy of less than 12 months in the judgment of the treating clinician.
Any condition that, in the investigator's opinion, would interfere with study participation or completion of follow-up, such as severe psychiatric instability or active substance use that precludes reliable follow-up
Adults aged 18 years or older with chronic pain localized to an anatomical region considered appropriate for cryoneurolysis by the treating physician and scheduled to undergo cryoneurolysis as standard clinical care.
Cohort
Prospective
Not listed
Percentage of participants with improvement in pain
Percentage of participants achieving a clinically meaningful improvement in pain. Pain improvement measured as a ≥2-point reduction on the 0-10 Numeric Rating Scale (NRS). NRS is a widely used, validated 0-10, tool for measuring subjective pain intensity, where 0 represents "no pain" and 10 represents "the worst pain imaginable".
Change in Pain Disability Index (PDI) score
PDI is a 7-item self-report questionnaire used to measure how chronic pain interferes with various aspects of a person's life, with total scores ranging from 0 (no disability) to 70 (maximum disability).
Number of pain-related hospital admissions
Number of pain-related hospital admissions in the 12 months before versus the 12 months after cryoneurolysis.
Number of pain-related emergency department visits
Number of pain-related emergency department visits in the 12 months before versus the 12 months after cryoneurolysis.
Number of pain-related medication refills
Number of pain-related medication refills in the 12 months before versus the 12 months after cryoneurolysis.
Number of responders
Responders are participants reporting 'much improved' or 'very much improved' using the Patient Global Impression of Change (PGIC).
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