Recruiting

Perfusion MRI

Sponsor:

Palo Alto Veterans Institute for Research

Code:

NCT05700682

Conditions

Osteoarthritis, Knee

Osteoarthritis, Hip

Osteo Arthritis Shoulders

Synovitis of Knee

Synovitis/Tenosynovitis - Hip

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Shoulder/Hip/Knee Embolization with Embozene Microspheres

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Osteoarthritis, Hip

Osteo Arthritis Shoulders

Synovitis of Knee

Synovitis/Tenosynovitis - Hip

Study ID

NCT05700682

Start date

Jul 15, 2023

Status verified date

Aug, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Shoulder/Hip/Knee Embolization with Embozene Microspheres

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

Primary outcome measure

  • Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only) [ Time Frame: Score obtained at follow-up visit 6 months after intervention ]
  • Primary Clinical Outcome (Shoulder, Therapeutic Arm Only) [ Time Frame: Score obtained at follow-up visit 6 months after intervention ]
  • Primary Imaging Outcome (Therapeutic Arm Only) [ Time Frame: Research MRI obtained 3 months after intervention ]

Central Contacts and Locations

Central contacts

Eric Bultman, MD, PhD

560-493-5000eric.bultman1@va.gov

Sirish Kishore, MD

650-493-5000sirish.kishore@va.gov

Locations

VA Palo Alto Healthcare System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Eric Bultman, MD/PhD

650-493-5000eric.bultman1@va.gov

Sirish Kishore, MD

sirish.kishore@va.gov

Principal Investigator:

Sirish Kishore, MD

More Information

Sponsor

Palo Alto Veterans Institute for Research

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • joint
  • embolization
  • neovascularity
  • pain
  • knee
  • hip
  • shoulder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research on 2025-08-07.