Chronic PainNCT07639060
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
An observational study of Chronic Pain and PERIPHERAL NEUROPATHY, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, PERIPHERAL NEUROPATHY, Occipital Neuralgia
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Muhammad U Siddique, MD contact
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Health Old Saybrook Medical Center
Old Saybrook, Connecticut, 06475
About this study
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
- Medical subject headings
- Chronic Pain, Peripheral Nervous System Diseases, Osteoarthritis, Hip, Osteoarthritis, Knee, Muscle Spasticity, Spondylosis, Causalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing cryoneurolysis | Participants undergoing cryoneurolysis for chronic pain as part of standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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).
Measured: 6 and 12 months
Secondary outcomes (4)
Number of pain-related hospital admissions
Number of pain-related hospital admissions in the 12 months before versus the 12 months after cryoneurolysis.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start20 Jun 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles A Odonkor, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639060
- Sponsor's protocol ID
- 2000042295
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
- ClinicalTrials.gov ID
- NCT07639060
- Acronym / sponsor ID
- 2000042295
- Conditions
- Chronic Pain, PERIPHERAL NEUROPATHY, Occipital Neuralgia, Chronic Hip Pain, Hip Osteoarthritis, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants undergoing cryoneurolysis | – | –Participants undergoing cryoneurolysis for chronic pain as part of standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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".
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).
4 secondary outcomes
Number of pain-related hospital admissions
Time frame: up to 12 months post cryoneurolysis
Number of pain-related emergency department visits
Time frame: up to 12 months post cryoneurolysis
Number of pain-related medication refills
Time frame: up to 12 months post cryoneurolysis
Number of responders
Time frame: 6 and 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad U Siddique, MD contact
Charles A Odonkor, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and PERIPHERAL NEUROPATHY, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles A Odonkor, MD (203-767-1555, charles.odonkor@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with improvement in pain (time frame: 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.