Embolization treatment for chronic shoulder pain
Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff
This study is testing if adding a special procedure called embolization to physical therapy can help people with ongoing shoulder pain from rotator cuff issues feel better compared to just doing physical therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06095050 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate to severe shoulder pain refractory to at least 6 months of conservative treatment.
Not a fit: Patients with complete full thickness tendon tears or significant peripheral arterial disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce shoulder pain and improve function for patients with chronic refractory tendinopathy.
How similar studies have performed: While embolization for shoulder pain is a novel approach, similar studies in other areas have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.