NCT07639060 · Yale University
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
What this study is about
To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.
View original scientific description
To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.
Primary outcome measures
Percentage of participants with improvement in pain
Time frame: 6 and 12 months
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
Time frame: 6 and 12 months
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- Old Saybrook, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations