NCT06095050 Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
| NCT ID | NCT06095050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Shoulder Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2027-01-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 41 participants in total. It began in 2025-01-16 with a primary completion date of 2027-01-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Yan Epelboym, MD, MPH
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06095050 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Shoulder Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06095050 currently recruiting?
Yes, NCT06095050 is actively recruiting participants. Contact the research team at yepelboym@bwh.harvard.edu for enrollment information.
Where is the NCT06095050 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06095050 clinical trial?
NCT06095050 is sponsored by Brigham and Women's Hospital. The principal investigator is Yan Epelboym, MD, MPH at Brigham and Women's Hospital. The trial plans to enroll 41 participants.