Targeting abnormal blood flow to treat chronic joint pain in veterans

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

This study is testing if treating abnormal blood flow in the joints can help veterans with chronic pain and osteoarthritis feel better.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 25 Years to 80 Years
• Sex: All
• Sponsor: Palo Alto Veterans Institute for Research (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT05700682 on ClinicalTrials.gov

What this trial studies

This study investigates the connection between chronic musculoskeletal pain and abnormal blood flow around the shoulder, hip, and knee in veterans. Participants with a history of chronic pain and mild to moderate osteoarthritis will undergo perfusion MRI to assess blood flow in their joints. Those with abnormal blood flow may be offered a joint embolization treatment, while others will be monitored over time to understand the natural progression of their condition. The study aims to gather data that could lead to new treatment options for chronic joint pain.

Who should consider this trial

Good fit: Ideal candidates are veterans with chronic shoulder, hip, or knee pain and mild to moderate degenerative changes who have not responded to standard treatments.

Not a fit: Patients with acute injuries or those without evidence of abnormal blood flow on MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for veterans suffering from chronic joint pain.

How similar studies have performed: While the approach of targeting neovascularity is innovative, similar studies have shown promise in treating chronic pain through embolization techniques.

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.

Where this trial is running

Palo Alto, California

• VA Palo Alto Healthcare System — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Sirish Kishore, MD — VA Palo Alto Health Care System
• Study coordinator: Eric Bultman, MD, PhD

Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders, Synovitis of Knee, Synovitis/Tenosynovitis - Hip, Synovitis, Pain, Chronic, joint