Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
Recruiting · NCT05700682 · Observational (researchers observe without assigning treatment) · Lead sponsor: Palo Alto Veterans Institute for Research
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.
Who can take part
Inclusion criteria
- Both Arms):
- Participants must be Veterans who receive care in the VA system.
- Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.
- Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).
- Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).
- Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.
- Inclusion Criteria (Therapeutic Arm):
- Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint.
- 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):
- Acute injury in the last 12 weeks.
- Age under 25.
- Severe degenerative changes of painful joint (shoulder, hip or knee).
- History of arthroplasty or metallic implant within the painful joint.
- Severe gadolinium contrast allergy.
- Severe renal disease or ongoing dialysis.
- History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis.
- Current pregnancy.
- Formal diagnosis of cognitive impairment.
- Exclusion Criteria (Therapeutic Arm):
- Severe iodinated contrast allergy.
- Severe coronary or peripheral arterial disease.
- Coagulopathy.
- Uncontrolled type 2 diabetes or diabetic neuropathy.
- History of seizures or other severe complication from conscious sedation.
- Prior upper or lower extremity arterial bypass.
- Ongoing participation in another interventional (therapeutic) trial for chronic joint pain.
- Lack of peri-articular hypervascularity on initial perfusion MRI.
- All exclusion criteria for the Diagnostic Arm.
Where it is running
1 location listed across 1 US state.
- VA Palo Alto Healthcare System - Palo Alto, California, United States