Causalgia, Cervical Spondylosis, Chronic Hip Pain, Chronic Low Back Pain, Chronic Neck Pain, Chronic Pain, Chronic Pain Syndrome, Hip Osteoarthritis, Knee Osteoarthritis, Lumbar Spondylosis, Occipital Neuralgia, PERIPHERAL NEUROPATHY, Shoulder Arthritis, Spasticity
Conditions
Brief summary
To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.
Interventions
None listed
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with improvement in pain | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of pain-related hospital admissions | up to 12 months post cryoneurolysis | Number of pain-related hospital admissions in the 12 months before versus the 12 months after cryoneurolysis. |
| Number of pain-related emergency department visits | up to 12 months post cryoneurolysis | Number of pain-related emergency department visits in the 12 months before versus the 12 months after cryoneurolysis. |
| Number of pain-related medication refills | up to 12 months post cryoneurolysis | Number of pain-related medication refills in the 12 months before versus the 12 months after cryoneurolysis. |
| Number of responders | 6 and 12 month | Responders are participants reporting 'much improved' or 'very much improved' using the Patient Global Impression of Change (PGIC). |
Countries
United States
Contacts
CONTACTCharles A Odonkor, MD
CONTACTMuhammad U Siddique, MD
PRINCIPAL_INVESTIGATORCharles A Odonkor, MD
Yale University
Outcome results
None listed