Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

Shoulder Pain Clinical Trial

— ELECTRC  

Official title:

Efficacy of Lipiodol Embolization for Chronic Tendinopathy of the Rotator Cuff

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06095050
• Other study ID #: 2023P002574
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Brigham and Women's Hospital
• Contact: Yan Epelboym, MD, MPH
• Phone: 6177327257
• Email: yepelboym[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 41
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arterial Occlusion
• Arterial Occlusive Diseases
• Embolization
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Rotator Cuff Tendinosis
• Shoulder Pain
• Tendinopathy

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months
Secondary	Patient-Reported Outcomes Measurement Information System Upper Extremity	Estimate the effect of TAE + PT vs PT on the change in Patient-Reported Outcomes Measurement Information System Upper Extremity scores at 1, 3, 6 and 12-months. A higher score indicates a better outcome. The scores can range from 15 to 61and are scored on what is called a T-score, a metric which reflects one standard deviation for each 10 points.	12 months
Secondary	Shoulder Pain and Disability Index	estimate the effect of TAE + PT vs PT on the change in Shoulder Pain and Disability Index scores at 1, 3, 6 and 12-months. The scale is a ratio scale of 0 to 130 with higher scores indicating greater degree of pain and disability.	12 months
Secondary	MRI Tendinopathy scores	Estimate the effect of TAE + PT vs PT on the change in MRI Tendinopathy scores at baseline and 12-months. The scale is ordinal and ranges from 0 to 3 with higher scores indicating a greater degree of tendinopathy.	12 months