Status:
RECRUITING
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Shoulder Pain
Tendinopathy
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative ...
Detailed Description
This is a single center prospective randomized controlled study at Brigham \& Women's Hospital (BWH), a teaching hospital of Harvard Medical School. Patients with clinical and MRI findings of shoulder...
Eligibility Criteria
Inclusion
- Male, female, transgender female, transgender male, non-binary
- Moderate to severe shoulder pain (VAS \> 40)
- 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
- Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy
Exclusion
- 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
- Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
- Acute kidney injury
- Allergy to poppy seeds or lipiodol
- Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
- Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.8 within 30 days of procedure
- Active systemic or local upper extremity infection
- Patient pregnant, intending to become pregnant during the study.
- Prior shoulder replacement surgery
- Prior rotator cuff repair surgery
- Previous history of complete full-thickness tear of the rotator cuff
- Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2027
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06095050
Start Date
January 16 2025
End Date
April 21 2027
Last Update
January 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115