Recruiting

Embolization

Sponsor:

Brigham and Women's Hospital

Code:

NCT06095050

Conditions

Shoulder Pain

Tendinopathy

Rotator Cuff Tendinitis

Rotator Cuff Tendinosis

Embolization

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Embolization

Physical Therapy

Study Details

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.

Conditions

Shoulder Pain

Tendinopathy

Rotator Cuff Tendinitis

Rotator Cuff Tendinosis

Embolization

Study ID

NCT06095050

Start date

Jan 16, 2025

Status verified date

Feb, 2026

Completion date

Apr 21, 2028

Anticipated

Primary completion date

Jan 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

41 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Embolization

Angiography will be performed to identify hyperemic neovasculature arising from one or more of branch shoulder arteries. After localizing the abnormal neovessels a microcatheter will be inserted coaxially and selectively placed in the targeted artery(ies). The abnormal vessels will be embolized with Lipiodol emulsion (Guerbet, Villepinte, France) The embolic agent will be used under an investigational device exemption from the FDA. The embolic will be injected in small volume increments until blood flow stagnates in the target artery(ies).

Angiography and embolization will be repeated until the hyperemia is markedly reduced as demonstrated on digital subtraction angiography.

Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

active comparator: Physical Therapy

Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

Interventions

Embolization

Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.

Physical Therapy

Subjects will participate in structured physical therapy consisting of 3 months of eccentric strength training. This twelve-week program will consist of 4 PT sessions at week 0, week 4, week 8, and week 12.

Primary outcome measure

  • Visual Analog Scale Pain (VAS) Score [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Yan Epelboym, MD, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • pain
  • shoulder pain
  • tendinopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-02-06.