Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

NCT ID: NCT06095050

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2027-04-21

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.

Detailed Description

This is a single center prospective randomized controlled study at Brigham & Women's Hospital (BWH), a teaching hospital of Harvard Medical School. Patients with clinical and MRI findings of shoulder tendinopathy, moderate to severe shoulder pain (VAS > 40), and pain refractory to at least 6 months of physician directed conservative therapy will be eligible for enrollment.At screening patient will undergo a shoulder MRI to evaluate for tendinopathy, and patients with complete full thickness tendon tears will be excluded.

Patients will be randomized to either the TAE +PT or PT group. Patients in the TAE + PT group will undergo angiography to evaluate branch shoulder arteries for hyperemia. If hyperemia is present, then embolization will be performed. This treatment will be followed by 3 months of structured PT. Patients in the PT group will undergo 3-months of structured physical therapy with isolated eccentric exercises.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Embolization

Intervention Type: DEVICE

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

Physical Therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan Epelboym, M.D.,M.P.H.

Interventional Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Epelboym, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yan Epelboym, MD, MPH

Role: CONTACT

yepelboym@bwh.harvard.edu

6177327257

Facility Contacts

Yan Epelboym, MD, MPH

Role: primary

yepelboym@bwh.harvard.edu

617-732-7257

Other Identifiers

2023P002574

Identifier Type: -

Identifier Source: org_study_id