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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
VA Palo Alto Healthcare System
RECRUITING
Palo Alto
Contact Information
Primary
Eric Bultman, MD, PhD
eric.bultman1@va.gov
560-493-5000
Backup
Sirish Kishore, MD
sirish.kishore@va.gov
650-493-5000
Time Frame
Start Date:2023-07-15
Estimated Completion Date:2026-08-01
Participants
Target number of participants:120
Treatments
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.