Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee

Launched by PALO ALTO VETERANS INSTITUTE FOR RESEARCH · Jan 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how chronic pain in the shoulder, hip, and knee might be connected to unusual blood flow around these joints. Researchers are particularly interested in veterans who have been living with pain in these areas for at least a year and have tried other treatments, like physical therapy or pain medications, without success. If a participant shows abnormal blood flow through a special type of MRI called perfusion MRI, they may qualify for a new treatment called joint embolization aimed at reducing their pain.

To be eligible, participants must be veterans receiving care in the VA system, have mild to moderate joint damage visible on previous imaging, and have a history of chronic pain. Those who choose not to have the treatment will still be part of the study, allowing researchers to learn more about how this abnormal blood flow relates to ongoing pain over time. This trial is currently recruiting participants and welcomes all eligible veterans, regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Both Arms):
• • 1. Participants must be Veterans who receive care in the VA system.
• • 2. Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.
• • 3. Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).
• • 4. Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).
• • 5. Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.
• Inclusion Criteria (Therapeutic Arm):
• • 1. Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint.
• • 2. Participants must have evidence of peri-articular hypervascularity on their perfusion MR exams. This will be determined by the study PIs.
• Exclusion Criteria (Diagnostic Arm):
• • 1. Acute injury in the last 12 weeks.
• • 2. Age under 25.
• • 3. Severe degenerative changes of painful joint (shoulder, hip or knee).
• • 4. History of arthroplasty or metallic implant within the painful joint.
• • 5. Severe gadolinium contrast allergy.
• • 6. Severe renal disease or ongoing dialysis.
• • 7. History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis.
• • 8. Current pregnancy.
• • 9. Formal diagnosis of cognitive impairment.
• Exclusion Criteria (Therapeutic Arm):
• • 1. Severe iodinated contrast allergy.
• • 2. Severe coronary or peripheral arterial disease.
• • 3. Coagulopathy.
• • 4. Uncontrolled type 2 diabetes or diabetic neuropathy.
• • 5. History of seizures or other severe complication from conscious sedation.
• • 6. Prior upper or lower extremity arterial bypass.
• • 7. Ongoing participation in another interventional (therapeutic) trial for chronic joint pain.
• • 8. Lack of peri-articular hypervascularity on initial perfusion MRI.
• • 9. All exclusion criteria for the Diagnostic Arm.