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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT06171659
Eligibility Criteria:
Inclusion Criteria: Persistent Post-Surgical Pain Patients
* 18-85 years old
* Presents with persistent pain with pain score of ≥4 on Numerical Rating Scale \[0:10\] for at least 6 months following joint arthroplasty or arthroscopy.
* Able and willing to provide informed consent
* Willing and able to undergo PET/MRI (arthroplasty and arthroscopy participants) and PET/CT (arthroplasty participants only)
Inclusion Criteria: Asymptomatic controls
* 18-85 years old
* Asymptomatic (pain score of ≤2 on the NRS) for at least 6 months following joint arthroplasty or arthroscopy.
* Able and willing to provide informed consent
* Willing and able to undergo PET/MRI
Exclusion Criteria:
* Inability to understand and communicate with the investigators to complete the study-related questionnaires.
* Any co-morbidity which results in severe systemic disease limiting function as defined by the American Society of Anesthesiology (ASA) physical status classification \> 3, such as the presence of current or past (6 months) pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to chronic pain.
* Pregnant or breastfeeding. (Individuals with childbearing potential will be asked to verbally confirm they are not pregnant. If they cannot confirm, they will have a urine pregnancy test either at the imaging study visit or within 7 days prior to the imaging study visit.)
* Subject with contraindication(s) to or inability to undergo PET/MRI
* Current diagnosis of malignancy of any kind. Participants in remission for at least two years and not undergoing any treatment may be considered per investigator discretion
* Current enrollment in a scientific interventional or treatment study.
* Subject unable or unwilling to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06171659
Study Brief:
Protocol Section:
NCT06171659