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

NCT07639060 | Not Yet Recruiting

• 1 other identifier: 2000042295
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; PERIPHERAL NEUROPATHY; Occipital Neuralgia; Chronic Hip Pain; Hip Osteoarthritis; Knee Osteoarthritis; Spasticity; Chronic Low Back Pain; Causalgia; Lumbar Spondylosis; Cervical Spondylosis; Shoulder Arthritis; Chronic Pain Syndrome; Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of pain-related hospital admissions

  up to 12 months post cryoneurolysis

• Number of pain-related emergency department visits

  up to 12 months post cryoneurolysis

• Number of pain-related medication refills

  up to 12 months post cryoneurolysis

• Number of responders

  6 and 12 month

Study Arms (1)

Participants undergoing cryoneurolysis

Participants undergoing cryoneurolysis for chronic pain as part of standard clinical care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Chronic Pain; Peripheral Nervous System Diseases; Osteoarthritis, Hip; Osteoarthritis, Knee; Muscle Spasticity; Spondylosis; Causalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Spinal Diseases; Bone Diseases; Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Neuralgia

Study Officials

• Charles A Odonkor, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles A Odonkor, MD

CONTACT

203-767-1555; charles.odonkor@yale.edu

Muhammad U Siddique, MD

CONTACT

muhammad.siddique@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share