Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Recruiting now · Not applicable

Conditions studied: Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Embolization, Arterial Occlusion

In brief

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 treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

Key facts

Study ID

NCT06095050

Run by

Brigham and Women's Hospital

People needed

41

Starts

2025-01-16

Expected to finish

2028-04-21

Last updated by the study team

2026-02-06

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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