ELECTRC: Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06095050

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain Tendinopathy Rotator Cuff Tendinitis Rotator Cuff Tendinosis Embolization Arterial Occlusion	Device: Embolization with Physical Therapy Other: Physical Therapy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single center prospective randomized controlled studySingle center prospective randomized controlled study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Embolization with Physical Therapy 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: Embolization with Physical Therapy Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
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.	Other: 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.

Arm

Intervention/Treatment

Experimental: Embolization with Physical Therapy

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: Embolization with Physical Therapy

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

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.

Other: Physical Therapy

Outcome Measures

Primary Outcome Measures

Visual Analog Scale Pain (VAS) Score [12 months]
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 [12 months]
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 [12 months]
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) [12 months]
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 [12 months]
Estimate the effect of TAE + PT vs PT on the change in MRI Tendinopathy scores at baseline and 12-months

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).