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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | The investigators will target VA patients with clinically-ordered knee, hip and shoulder MRIs for recruitment (40 for each joint). Patients who elect to participate will undergo perfusion MRI add-on sequence at the end of their clinical MRI. Arterial-phase maximum intensity projection images from the perfusion MR data will be generated, and the presence of abnormal vascularity about each joint will be assessed by the study principal investigators. Participants who have focal or generalized peri-articular hypervascularity will be offered enrollment in the Therapeutic Arm of the study. Those participants who decline enrollment into the Therapeutic Arm, and those without significant peri-articular vascularity on perfusion MRI, will be asked to return for follow-up clinical and imaging visits so that the natural history of pain/imaging parameters in the absence of treatment can be evaluated. | ||
| Therapeutic | Of 40 participants enrolled for each joint, the investigators anticipate 20 will choose to enroll in an embolization pilot study. Participants must have peri-articular hypervascularity on perfusion MRI and must have failed at least one first line therapy for their pain to be eligible. Embolization will be performed as an outpatient procedure under conscious sedation. Further description of this procedure is available in the study protocol and literature. Technical success will be defined as selective embolization of at least one abnormal peri-articular artery. After embolization, participants will return for clinical follow-up at 1, 3, 6 and 12 months with perfusion MRI performed at the 3- and 12-month visits. Clinical follow-up at 3, 6 and 12 months will consist only of surveys (WOMAC/WORC). Participants will be instructed to avoid additional treatments for their joint pain when possible, and if a second treatment is initiated to report it to the study investigators. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder/Hip/Knee Embolization with Embozene Microspheres | Device | Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only) | Composite WOMAC survey score | Score obtained at follow-up visit 6 months after intervention |
| Primary Clinical Outcome (Shoulder, Therapeutic Arm Only) | Composite WORC survey score | 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) | Research MRI obtained 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only) | Composite WOMAC survey score | Score obtained at follow-up visit after 12 months |
| Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only) |
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Inclusion Criteria (Both Arms):
Inclusion Criteria (Therapeutic Arm):
Exclusion Criteria (Diagnostic Arm):
Exclusion Criteria (Therapeutic Arm):
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Participants will be veterans eligible for care at the VA. Anticipated age range is 25-80. Gender will be predominantly male (approximately 90%), concordant with demographic information of the VA population. Pregnant women, children, vulnerable subjects, study personnel and students will not be eligible for enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Bultman, MD, PhD | Contact | 560-493-5000 | 61502 | eric.bultman1@va.gov |
| Sirish Kishore, MD | Contact | 650-493-5000 | sirish.kishore@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Sirish Kishore, MD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Healthcare System | Recruiting | Palo Alto | California | 94304 | United States |
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Composite WORC survey score
| 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) | 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) | Research MRI obtained after 12 months of follow-up |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D013585 | Synovitis |
| D059350 | Chronic Pain |
| D009389 | Neovascularization, Pathologic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
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