Actively Recruiting
Perfusion MRI-targeted Joint Embolization to Diagnose and Treat Neovascularity Associated With Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee: A Prospective Cohort Study
Led by Palo Alto Veterans Institute for Research · Updated on 2025-08-07
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
P
Palo Alto Veterans Institute for Research
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the connection between chronic musculoskeletal pain and abnormal blood flow, called neovascularity, around the shoulder, hip, and knee joints in Veterans. This study focuses on individuals with a history of chronic joint pain lasting at least one year and mild to moderate joint degeneration, aiming to better understand how these blood flow changes relate to pain. The research includes both diagnostic evaluation and a pilot treatment study using joint embolization. Participants undergo perfusion magnetic resonance imaging (MRI) to detect abnormal blood flow around the painful joint. Those without abnormal blood flow remain in the Diagnostic Arm, completing surveys and follow-up MRIs over one year to observe natural changes. Participants with abnormal blood flow may join the Therapeutic Arm, receiving embolization treatment using Embozene microspheres to block abnormal vessels under fluoroscopic guidance. Follow-up visits and MRI scans occur over the following year to track symptoms and imaging outcomes. Throughout the study, participants complete pain surveys (WOMAC or WORC) and undergo imaging at scheduled intervals. The Therapeutic Arm includes clinical visits at 1, 3, 6, and 12 months after treatment, with MRIs at 3 and 12 months. Those in the Diagnostic Arm complete surveys at 6 months and 1 year, plus an MRI at 1 year. Researchers will assess clinical pain scores and imaging markers to evaluate the relationship between joint blood flow and pain, with total study participation lasting approximately 2.5 to 3 years including recruitment and data analysis.
CONDITIONS
Brief Title
Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be a Veteran receiving care in the VA system
- History of chronic pain in the shoulder, hip, or knee for at least 1 year
- Mild to moderate degenerative changes in the painful joint shown on prior imaging (X-ray, CT, or MRI)
- At least one failed primary treatment for chronic pain, such as physical therapy, NSAIDs, or steroid injection
- An MRI of the painful joint ordered by a clinical provider
- For Therapeutic Arm: must have undergone perfusion MRI and have peri-articular hypervascularity on imaging
You will not qualify if you...
- Acute injury within the past 12 weeks
- Age under 25 years
- Severe degenerative changes in the painful joint
- History of arthroplasty or metallic implant in the painful joint
- Severe allergy to gadolinium contrast
- Severe kidney disease or ongoing dialysis
- History of cancer with life expectancy less than one year or bone metastasis
- Current pregnancy
- Formal diagnosis of cognitive impairment
- Severe allergy to iodinated contrast
- Severe coronary or peripheral arterial disease
- Blood clotting disorders
- Uncontrolled type 2 diabetes or diabetic neuropathy
- History of seizures or severe reaction to conscious sedation
- Prior arterial bypass surgery in upper or lower extremities
- Participation in another interventional trial for chronic joint pain
- Lack of peri-articular hypervascularity on initial perfusion MRI
- All exclusion criteria for the Diagnostic Arm apply to Therapeutic Arm participants
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person) coinciding with the clinical MRI exam
Duration - 1 year
Participants undergo perfusion MRI and cartilage parameter mapping as an add-on to their clinical MRI exam, and complete baseline pain surveys. Participants without neovascularity remain in this arm for follow-up.
Baseline MRI visit; follow-up surveys at 6 months and 12 months; research MRI at 12 months
Duration - Outpatient procedure with follow-up over 1 year
Participants with neovascularity who enroll in the Therapeutic Arm undergo fluoroscopically-guided arterial embolization of the affected joint using Embozene microspheres.
1 outpatient embolization visit; 1 clinic follow-up visit at 2 weeks post-procedure
Duration - 12 months post-treatment
Following embolization, participants complete symptom surveys and undergo research MRIs to monitor treatment effects.
Symptom surveys at 1, 3, 6, and 12 months post-treatment; research MRIs at 3 and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
VA Palo Alto Healthcare System
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
E
Eric Bultman, MD, PhD
S
Sirish Kishore, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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