FDG PET/MR Imaging of Peripheral Pain Generators

Launched by UNIVERSITY OF WISCONSIN, MADISON · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether a specialized imaging technique called FDG PET/MRI can help doctors find the exact source of chronic pain in patients. By accurately identifying where the pain is coming from, the goal is to improve treatment options for people suffering from persistent pain. The study will include about 128 participants who are either experiencing ongoing pain after surgery or who have not had any pain.

To be eligible for the study, participants must be between 18 and 85 years old. Those with chronic pain should have a pain level of 4 or higher on a scale from 0 to 10 for at least six months after joint surgery. Asymptomatic participants should have minimal pain (2 or lower on the same scale) for the same period. If you join the study, you can expect to be involved for up to 12 months, during which you will undergo imaging tests to help researchers gather valuable information about your pain. It's important to note that certain health conditions or situations, like being pregnant or having severe systemic diseases, may disqualify someone from participating.

Gender

ALL

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