Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06095050
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Embolization — 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 — 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.

Study Details

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.

Key Dates

Start date
Jan 16, 2025
Status verified
Feb 2026
Primary completion
Jan 16, 2027
Completion
Apr 21, 2028

Study Design

Enrollment
41 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Yan Epelboym, MD, MPH
[email protected]
617-732-7257
Yan Epelboym, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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