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Embolization Treatment of Chronic Refractory Shoulder Tendinopathy (ELECTRC)

Primary Purpose

Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Embolization with Physical Therapy
Physical Therapy
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring pain, shoulder pain, tendinopathy

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Embolization with Physical Therapy

    Physical Therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale Pain (VAS) Score
    The difference in shoulder VAS pain scores between TAE +PT and PT groups obtained 12 months following intervention vs. pre-intervention.

    Secondary Outcome Measures

    Adverse Events
    Compare the safety of TAE + PT relative to PT by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention
    Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
    Estimate the effect of TAE + PT vs PT on the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity scores at 1, 3, 6 and 12-months
    Shoulder Pain and Disability Index (SPADI)
    estimate the effect of TAE + PT vs PT on the change in Shoulder Pain and Disability Index (SPADI) scores at 1, 3, 6 and 12-months
    MRI Tendinopathy scores
    Estimate the effect of TAE + PT vs PT on the change in MRI Tendinopathy scores at baseline and 12-months

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095050
    Brief Title
    Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
    Acronym
    ELECTRC
    Official Title
    Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Embolization, Arterial Occlusion
    Keywords
    pain, shoulder pain, tendinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single center prospective randomized controlled study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    41 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Embolization with Physical Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Physical Therapy
    Arm Type
    Active Comparator
    Arm Description
    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
    Device
    Intervention Name(s)
    Embolization with Physical Therapy
    Intervention Description
    Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Physical Therapy
    Intervention Description
    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 Information:
    Title
    Visual Analog Scale Pain (VAS) Score
    Description
    The difference in shoulder VAS pain scores between TAE +PT and PT groups obtained 12 months following intervention vs. pre-intervention.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Adverse Events
    Description
    Compare the safety of TAE + PT relative to PT by recording adverse events at 1 month, 3 months, 6 months, and 12 months post intervention
    Time Frame
    12 months
    Title
    Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
    Description
    Estimate the effect of TAE + PT vs PT on the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity scores at 1, 3, 6 and 12-months
    Time Frame
    12 months
    Title
    Shoulder Pain and Disability Index (SPADI)
    Description
    estimate the effect of TAE + PT vs PT on the change in Shoulder Pain and Disability Index (SPADI) scores at 1, 3, 6 and 12-months
    Time Frame
    12 months
    Title
    MRI Tendinopathy scores
    Description
    Estimate the effect of TAE + PT vs PT on the change in MRI Tendinopathy scores at baseline and 12-months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Epelboym, MD, MPH
    Phone
    6177327257
    Email
    yepelboym@bwh.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Epelboym, MD, MPH
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

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