Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Embolization
  • Physical Therapy

Treatment groups

41 Participants
are divided into 2 treatment groups

Sponsors and collaborators