Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06837857
Eligibility Criteria:
Inclusion Criteria:
* 65 years of age or older
* Pain for longer than 3 months (chronic)
* Moderate to severe pain nearly every day (averaged PEG score \>5)
* Persistent pain despite use of \>1 analgesic (Tylenol, Ibuprofen, lidocaine patch, etc)
Exclusion Criteria:
* Untreated severe/uncontrolled Mental health (schizophrenia, bipolar disorder, psychosis, history of suicidality, depression or anxiety, PTSD)
* Severe liver (cirrhosis) or kidney disease (ESRD on dialysis or GFR\< 30)
* Cognitive impairment (Kokmen Short Test of Mental Status score \< 29)
* Life expectancy \< 12 months
* Contraindications to MRI
* Non-English speaking
* Opioid use within the past 6 months
* Contraindications or previous intolerance to prescription opioids
* Substance use disorder or high-risk for opioid-related adverse effects (Opioid Risk Tool ≥ 8)
* Residence outside of Minnesota or Wisconsin during opioid intervention period
* Another pain generator that is greater than their knee or shoulder or low back pain
* Anticipated surgery for joint replacement (Knee or shoulder) sooner than 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06837857
Study Brief:
Protocol Section:
NCT06837857