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New procedure could ease stubborn shoulder pain

NCT ID NCT06095050

Symptom relief Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a minimally invasive procedure called transcatheter arterial embolization (TAE) combined with physical therapy for people with chronic shoulder pain from rotator cuff tendinopathy that hasn't improved with standard treatments. About 41 adults with moderate to severe pain will be randomly assigned to receive TAE plus physical therapy or physical therapy alone. The main goal is to see if the combination reduces pain more effectively after 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 41 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

arterial occlusion Arterial Occlusive Diseases disease of the tendon Pain Rotator Cuff Injuries rotator cuff syndrome Shoulder Pain tendinitis tendinosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arterial occlusion Embolization Rotator cuff tendinitis Rotator cuff tendinosis Shoulder pain Tendinopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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