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RecruitingNCT07639060Updated Aug 21, 2026

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

An observational study in Chronic Pain, PERIPHERAL NEUROPATHY and Occipital Neuralgia, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain
  • PERIPHERAL NEUROPATHY
  • Occipital Neuralgia
  • Chronic Hip Pain
  • Hip Osteoarthritis
  • Knee Osteoarthritis
  • Spasticity
  • Chronic Low Back Pain
  • Lumbar Spondylosis
  • Cervical Spondylosis
  • Shoulder Arthritis
  • Causalgia
  • Chronic Pain Syndrome
  • Chronic Neck Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants undergoing cryoneurolysis

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

05

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 6 and 12 months

  2. 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).

    Time frame: 6 and 12 months

Secondary outcomes

  1. Number of pain-related hospital admissions

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

    Time frame: up to 12 months post cryoneurolysis

  2. 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.

    Time frame: up to 12 months post cryoneurolysis

  3. Number of pain-related medication refills

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

    Time frame: up to 12 months post cryoneurolysis

  4. Number of responders

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

    Time frame: 6 and 12 month

06

Study locations

1 of 1 sites recruiting
  • Yale New Haven Health Old Saybrook Medical Center
    Old Saybrook, Connecticut 06475, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07639060
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Jun 10, 2026
Start date
Jun 20, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Charles A Odonkor, MD
Contact
charles.odonkor@yale.edu
203-767-1555
Muhammad U Siddique, MD
Contact
muhammad.siddique@yale.edu
Charles A Odonkor, MD
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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