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New treatment option for Shoulder Pain
Official title Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
ClinicalTrials.gov ID: NCT06095050
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- 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
You likely can't join if
- History of peripheral arterial disease or peripheral artery disease symptoms including claudication, diminished or absent upper/lower extremity...
- 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 \ 1.8 within 30 days of procedure
See the full eligibility 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
- 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...
- 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 \ 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).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.