Arterial Occlusion, Embolization, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Shoulder Pain, Tendinopathy
Conditions
Keywords
pain, shoulder pain, tendinopathy
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.
Interventions
DEVICEEmbolization
Superselective arterial embolization of hyperemic vasculature in the symptomatic shoulder (utilizing the IDE approved device: Lipiodol) followed by structured physical therapy sessions.
OTHERPhysical 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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single center prospective randomized controlled study
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain (VAS) Score | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Upper Extremity | 12 months | 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. |
| Shoulder Pain and Disability Index | 12 months | 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. |
| 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. The scale is ordinal and ranges from 0 to 3 with higher scores indicating a greater degree of tendinopathy. |
Countries
United States
Contacts
CONTACTYan Epelboym, MD, MPH
PRINCIPAL_INVESTIGATORYan Epelboym, MD, MPH
Brigham and Women's Hospital
Outcome results
None listed