Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Description

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.

Conditions

Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Embolization, Arterial Occlusion

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Study Overview

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Study Details

Study overview

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.

Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Condition
Shoulder Pain
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Yan Epelboym, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2027-04-21