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To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing cryoneurolysis | Participants undergoing cryoneurolysis for chronic pain as part of standard clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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". | 6 and 12 months |
| 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). | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pain-related hospital admissions | Number of pain-related hospital admissions in the 12 months before versus the 12 months after cryoneurolysis. | up to 12 months post cryoneurolysis |
| Number of pain-related emergency department visits |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles A Odonkor, MD | Contact | 203-767-1555 | charles.odonkor@yale.edu | |
| Muhammad U Siddique, MD | Contact | 203-668-2772 | muhammad.siddique@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charles A Odonkor, MD | Yale University | Principal Investigator |
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Number of pain-related emergency department visits in the 12 months before versus the 12 months after cryoneurolysis.
| up to 12 months post cryoneurolysis |
| Number of pain-related medication refills | Number of pain-related medication refills in the 12 months before versus the 12 months after cryoneurolysis. | up to 12 months post cryoneurolysis |
| Number of responders | Responders are participants reporting 'much improved' or 'very much improved' using the Patient Global Impression of Change (PGIC). | 6 and 12 month |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010523 | Peripheral Nervous System Diseases |
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| D009128 | Muscle Spasticity |
| D055009 | Spondylosis |
| D002422 | Causalgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D020918 | Complex Regional Pain Syndromes |
| D001342 | Autonomic Nervous System Diseases |
| D009437 | Neuralgia |
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