Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people suffering from chronic shoulder pain due to conditions like rotator cuff tendinopathy, which hasn't improved with standard treatments. The researchers want to see if a procedure called transcatheter arterial embolization (TAE), combined with physical therapy, can help reduce shoulder pain more effectively than physical therapy alone. Participants will be followed for 12 months to measure their pain levels and overall shoulder function.

To be eligible for the trial, participants should be experiencing moderate to severe shoulder pain that has not responded to at least six months of medical treatment, including physical therapy. Anyone who is willing and able to provide informed consent and can tolerate the procedures involved may be considered. Participants in the trial can expect to undergo either the TAE procedure or continue with physical therapy alone, and they'll have their pain and shoulder function assessed regularly throughout the study. It's important for potential participants to know that there are specific health conditions that would exclude them from the trial, so discussing their health history with the research team is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male, female, transgender female, transgender male, non-binary
• • 2. Moderate to severe shoulder pain (VAS \> 40)
• • 3. Pain refractory to at least 6 months of physician-directed conservative therapy (analgesics or injections or PT), including a minimum of 6 weeks of PT
• • 4. Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy
• Exclusion Criteria:
• • 1. History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity pulses, or known upper extremity arterial atherosclerosis or occlusion that would limit selective angiography
• • 2. Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
• • 3. Acute kidney injury
• • 4. Allergy to poppy seeds or lipiodol
• • 5. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
• • 6. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.8 within 30 days of procedure
• • 7. Active systemic or local upper extremity infection
• • 8. Patient pregnant, intending to become pregnant during the study.
• • 9. Prior shoulder replacement surgery
• • 10. Prior rotator cuff repair surgery
• • 11. Previous history of complete full-thickness tear of the rotator cuff
• • 12. Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).