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

NCT ID
NCT05700682
Registry status
Recruiting
Study type
Observational
Sponsor
Palo Alto Veterans Institute for Research
Conditions
Osteo Arthritis Shoulders, Osteoarthritis, Hip, Osteoarthritis, Knee, Pain, Chronic, Synovitis, Synovitis of Knee, Synovitis/Tenosynovitis - Hip

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 120 participants (Estimated).

What is being studied

  • Device: Shoulder/Hip/Knee Embolization with Embozene Microspheres

Who may be eligible

Ages
25 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • California, United States: 1

Sample of listed locations

  • VA Palo Alto Healthcare System — Palo Alto, California, 94304, United States — Recruiting

Study details

Start date
July 15, 2023
Primary completion date
March 1, 2026
Completion date
August 1, 2026
First posted
January 26, 2023
Collaborators
Varian Medical Systems

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05700682
Registry last updated
August 7, 2025
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT05700682 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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