RecruitingNCT05700682

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

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


Sponsor

Palo Alto Veterans Institute for Research

Enrollment

120 participants

Start Date

Jul 15, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 25 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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.
  • 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 Criteria17

  • 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.
  • 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.

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Interventions

DEVICEShoulder/Hip/Knee Embolization with Embozene Microspheres

Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.


Locations(1)

VA Palo Alto Healthcare System

Palo Alto, California, United States

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NCT05700682


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