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Tiny study on blood flow cuffs for shoulder injuries ends early

NCT ID NCT06223373

Symptom relief Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using a blood flow restriction (BFR) cuff during physical therapy could help people with shoulder injuries regain strength and return to activity faster. Only 3 people took part before the study was stopped early. The approach uses a special tourniquet to partly block blood flow to the arm during exercise, which may help prevent muscle loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Blood flow restriction (BFR) device
What this could lead to
If it works, this could offer a way to reduce muscle loss and speed up recovery after a shoulder injury.
What could go wrong
The study was terminated early and enrolled only 3 people, so there is very little data to draw conclusions from. Results may not be reliable or apply to others.

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

3 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2024

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

18 to 55 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: * injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy * no prior upper extremity ipsilateral procedures or history of deep vein thrombosis * those willing to be part of the study Exclusion Criteria: * patients younger than 18 or older than 55 years of age * a history of revision surgery or prior ipsilateral upper extremity surgery * concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol * inability to comply with the proposed follow-up clinic visits * patients lacking decisional capacity

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Conditions

The condition(s) this trial relates to.

bicipital tenosynovitis disease of the tendon muscular atrophy Shoulder Injuries

As listed by the trial registrant

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

Shoulder injury

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.