Embolization treatment for chronic shoulder pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of transcatheter arterial embolization (TAE) combined with physical therapy (PT) compared to PT alone in patients suffering from moderate to severe shoulder pain due to rotator cuff tendinopathy that has not improved with conservative treatments. Participants will undergo a shoulder MRI to confirm tendinopathy and will be randomized into two groups: one receiving TAE followed by structured PT, and the other receiving only structured PT. The primary outcome is the change in shoulder pain after 12 months, along with assessments of safety and various patient-reported outcomes.

Why it matters

Who can join: the full rules

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).

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Yan Epelboym, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Yan Epelboym, MD, MPH
• Email: yepelboym@bwh.harvard.edu
• Phone: 6177327257

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Functional electrical stimulation plus shoulder exercises for older adults with rotator cuff pain

  In older adults with rotator cuff–related shoulder pain, this study tests whether adding functional electrical stimulation to a shoulder exercise program improves muscle coordination and reduces impingement compared with exercises alone.

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• Shoulder pain patients: see if breathing and chest exercises help pain and sleep

  This study tests whether adding respiratory muscle strengthening and diaphragmatic breathing to shoulder rehab can reduce pain and improve sleep in adults with chronic shoulder pain.

  Recruiting Zonguldak Bulent Ecevit University · Zonguldak · NCT07885215

• Night Pain Module for Rotator Cuff-Related Shoulder Pain

  Researchers are testing a short set of questions to measure night pain in people with rotator cuff–related shoulder pain to see if it reliably describes how sleep is affected.

  Recruiting at 3 sites Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Istanbul and 2 other locations · NCT07838233

• Geniculate Artery Embolization for Knee Osteoarthritis in Cancer Patients

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• Nociplastic Pain in SAPS: A Look at Pain Types in Shoulder Pain

  This study tests how common nociplastic pain is among people with subacromial pain syndrome who have shoulder pain for at least 3 months.

  Recruiting Vejle Hospital · Vejle · NCT07792434

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.