Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain

To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Knee Osteoarthritis; Chronic Low Back Pain; Hip Osteoarthritis; Chronic Neck Pain; Chronic Pain Syndrome; Cervical Spondylosis; Spasticity; Causalgia; Shoulder Arthritis; Lumbar Spondylosis; Chronic Hip Pain; Occipital Neuralgia; PERIPHERAL NEUROPATHY

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Charles A Odonkor, MD; Phone Number: 203-767-1555; Email: charles.odonkor@yale.edu
• Study Contact Backup: Name: Muhammad U Siddique, MD; Email: muhammad.siddique@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants undergoing cryoneurolysis; Participants undergoing cryoneurolysis for chronic pain as part of standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Charles A Odonkor, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Spinal Diseases; Osteoarthritis; Autonomic Nervous System Diseases; Neuralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Complex Regional Pain Syndromes; Muscle Spasticity; Osteoarthritis, Knee; Chronic Pain; Peripheral Nervous System Diseases; Spondylosis; Osteoarthritis, Hip; Causalgia
• Other Study ID Numbers: 2000042295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No