NCT06095050

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Jan 2025Apr 2028

First Submitted

Initial submission to the registry

October 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2028

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

October 18, 2023

Last Update Submit

February 4, 2026

Conditions

Shoulder PainTendinopathyRotator Cuff TendinitisRotator Cuff TendinosisEmbolizationArterial Occlusion

Keywords

painshoulder paintendinopathy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Pain (VAS) Score

    The difference in shoulder visual analog pain scale scores between TAE +PT and PT groups obtained 12 months following intervention vs. pre-intervention. The visual analog scale is ratio scale from 0 to 100 which measures pain symptoms. On this scale higher numbers indicated more severe pain symptoms.

    12 months

Secondary Outcomes (4)

  • Adverse Events

    12 months

  • Patient-Reported Outcomes Measurement Information System Upper Extremity

    12 months

  • Shoulder Pain and Disability Index

    12 months

  • MRI Tendinopathy scores

    12 months

Study Arms (2)

Embolization

EXPERIMENTAL

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.

Device: EmbolizationOther: Physical Therapy

Physical Therapy

ACTIVE COMPARATOR

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.

Other: Physical Therapy

Interventions

EmbolizationDEVICE

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

Embolization
Physical TherapyOTHER

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.

EmbolizationPhysical Therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, female, transgender female, transgender male, non-binary
  • Moderate to severe shoulder pain (VAS \> 40)
  • 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
  • Willing, able, and mentally competent to provide informed consent and to tolerate angiography and physical therapy

You may not qualify if:

  • 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
  • Known history of anaphylaxis to iodinated contrast agents or gadolinium based contrast
  • Acute kidney injury
  • Allergy to poppy seeds or lipiodol
  • Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
  • Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.8 within 30 days of procedure
  • Active systemic or local upper extremity infection
  • Patient pregnant, intending to become pregnant during the study.
  • Prior shoulder replacement surgery
  • Prior rotator cuff repair surgery
  • Previous history of complete full-thickness tear of the rotator cuff
  • Presence of non-MRI compatible devices (e.g., non-compatible cardiac pacemaker).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Shoulder PainTendinopathyRotator Cuff InjuriesArterial Occlusive DiseasesPain

Interventions

Embolization, TherapeuticPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesTendon InjuriesWounds and InjuriesRuptureShoulder InjuriesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic OcclusionRehabilitation

Study Officials

  • Yan Epelboym, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Epelboym, MD, MPH

CONTACT

6177327257yepelboym@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single center prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Radiologist

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 23, 2023

Study Start

January 16, 2025

Primary Completion (Estimated)

January 16, 2027

Study Completion (Estimated)

April 21, 2028

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)