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NCT Number: NCT07639060

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.

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Key information

Conditions

Chronic Pain Arthritis Autonomic Nervous System Diseases Bone Diseases Causalgia Cervical Spondylosis Chronic Hip Pain Chronic Low Back Pain Chronic Neck Pain Chronic Pain Syndrome Complex Regional Pain Syndromes Hip Osteoarthritis Joint Diseases Knee Osteoarthritis Lumbar Spondylosis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Occipital Neuralgia Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathy Rheumatic Diseases Shoulder Arthritis Signs and Symptoms Spasticity Spinal Diseases Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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".

  2. 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).

Secondary outcomes

  1. Number of pain-related hospital admissions

    Time frame: up to 12 months post cryoneurolysis

    Number of pain-related hospital admissions in the 12 months before versus the 12 months after cryoneurolysis.

  2. Number of pain-related emergency department visits

    Time frame: up to 12 months post cryoneurolysis

    Number of pain-related emergency department visits in the 12 months before versus the 12 months after cryoneurolysis.

  3. Number of pain-related medication refills

    Time frame: up to 12 months post cryoneurolysis

    Number of pain-related medication refills in the 12 months before versus the 12 months after cryoneurolysis.

  4. Number of responders

    Time frame: 6 and 12 month

    Responders are participants reporting 'much improved' or 'very much improved' using the Patient Global Impression of Change (PGIC).

Study contacts

Contact information is provided by the study sponsor or research team.

Charles A Odonkor, MD

CONTACT

[email protected]

203-767-1555

Muhammad U Siddique, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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