NCT05700682 Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
| NCT ID | NCT05700682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Palo Alto Veterans Institute for Research |
| Condition | Osteoarthritis, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-07-15 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sirish Kishore, MD
PRINCIPAL INVESTIGATOR
VA Palo Alto Health Care System
Frequently Asked Questions
Who can join the NCT05700682 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 80 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05700682 currently recruiting?
Yes, NCT05700682 is actively recruiting participants. Contact the research team at eric.bultman1@va.gov for enrollment information.
Where is the NCT05700682 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05700682 clinical trial?
NCT05700682 is sponsored by Palo Alto Veterans Institute for Research. The principal investigator is Sirish Kishore, MD at VA Palo Alto Health Care System. The trial plans to enroll 120 participants.