NCT05700682 · Palo Alto Veterans Institute for Research
Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
(MRI)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Shoulder/Hip/Knee Embolization with Embozene Microspheres
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.
Primary outcome measures
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)
Time frame: Score obtained at follow-up visit 6 months after intervention
Composite WOMAC survey score
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)
Time frame: Score obtained at follow-up visit 6 months after intervention
Composite WORC survey score
Primary Imaging Outcome (Therapeutic Arm Only)
Time frame: Research MRI obtained 3 months after intervention
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Palo Alto, California
Collaborators
Varian Medical Systems
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2025 · Source of record for eligibility and locations