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.
1. Joint MRI (shoulder, hip, knee) is ordered by a clinical provider due to ongoing/chronic joint pain. At the time of MR exam protocoling, investigators review prior imaging and determine that the patient has mild-moderate osteoarthritis. Patient is identified as a potential participant and is sent a letter by physical mail or e-mail (signed by PIs) discussing the research project. Subsequently, the clinical research coordinator reaches out to the potential participant by phone 7-14 days before the date of the MR exam to assess interest in the study. 2. Participant is interested and enrolls in the Diagnostic Arm of the study. Upon enrollment, the participant will undergo perfusion MRI and cartilage parameter mapping at the time of the initial MR exam (a 15-minute "add on" scan with Multihance intravenous contrast at the end of the standard clinical MRI). The participant will also complete a WOMAC (knee/hip) or WORC (shoulder) survey to document the baseline characteristics of their pain. 3. If there is NO neovascularity on the perfusion MRI, the participant will remain in the Diagnostic Arm of the study. Participants who remain in the Diagnostic Arm will undergo follow-up WOMAC surveys at 6 months / 1 year; and a research perfusion MR at one year. Follow-up data from the 1-year visit will represent the primary clinical and imaging endpoints of the Diagnostic Arm. 4. If neovascularity is present, the participant will be offered enrollment into the Therapeutic Arm. Participants not interested in the Therapeutic Arm will remain in the Diagnostic Arm. 5. Participants who elect to enroll in the Therapeutic Arm of the study are referred to the study investigators, who will screen for exclusion criteria. Importantly, if the participant has risk factors for or confirmed peripheral arterial disease (PAD), they must undergo CT angiography of the relevant anatomy (abdomen/pelvis with or without lower extremity runoff). If the participant does not meet any exclusion criteria, they will be scheduled for embolization therapy of their painful joint (shoulder, hip or knee). The participant will undergo embolization under fluoroscopic guidance using Embozene microspheres. Briefly, the relevant arterial vessels supplying the joint of interest will be accessed with an arterial catheter. The presence of abnormal peri-articular vessels seen on MRI will be confirmed during fluoroscopic imaging with injection of contrast material (Omnipaque). These abnormal vessels will then be embolized via careful injection of bland embolic particles (Embozene microspheres). After embolization, participant will attend one clinic follow-up visit at 2 weeks to screen for side effects or complications. The participant will be surveyed for their symptoms (WOMAC/WORC) at 1, 3, 6 and 12-months post-treatment. They will undergo research MR exams perfusion and cartilage parameter mapping at 3- and 12-months post-treatment. 6. Recruitment will occur over 1.5 years. Follow-up in both Arms will occur over 1 year. After completion of the study, the investigators anticipate approximately 3-4 months will be required for data analysis and manuscript preparation. Total study duration will therefore be 2.5 to 3 years.
Study Type
OBSERVATIONAL
Enrollment
120
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.
VA Palo Alto Healthcare System
Palo Alto, California, United States
RECRUITINGPrimary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)
Composite WOMAC survey score
Time frame: Score obtained at follow-up visit 6 months after intervention
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)
Composite WORC survey score
Time frame: Score obtained at follow-up visit 6 months after intervention
Primary Imaging Outcome (Therapeutic Arm Only)
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Time frame: Research MRI obtained 3 months after intervention
Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)
Composite WOMAC survey score
Time frame: Score obtained at follow-up visit after 12 months
Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)
Composite WORC survey score
Time frame: Score obtained at follow-up visit after 12 months
Secondary Imaging Outcome (Diagnostic Arm Only)
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Time frame: Research MRI obtained after 12 months of follow-up
Secondary Imaging Outcome 2 (Diagnostic Arm Only)
Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)
Time frame: Research MRI obtained after 12 months of follow-up
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