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Knee pain study halted after just one patient

NCT ID NCT05617911

Symptom relief Sponsor: Gaylord Hospital, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if using a blood flow restriction cuff during exercise could reduce pain and improve function in people with patellofemoral pain syndrome (front knee pain). The plan was to compare the cuff to a sham (fake) cuff plus standard physical therapy. However, the study was stopped early after only one person enrolled, so no meaningful conclusions can be drawn.

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 Cuff
What this could lead to
If it works, this could offer a new therapy option for anterior knee pain that may improve recovery.
What could go wrong
The trial was terminated after enrolling only 1 participant, so results are not reliable. It is unclear if BFR therapy is better than standard care.

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

1 person

The number who actually took part.

Started

Nov 2022

Finished

Oct 2023

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

15 years and older

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: Diagnosis of patellofemoral pain syndrome (PFPS) or non-specific anterior knee pain (NSAKP) and plan to attend Gaylord Specialty Healthcare Physical Therapy Exclusion Criteria: Member of a defined vulnerable population, women who are or suspected to be pregnant, prisoners, children under 15, or other protected populations Body mass of the leg preventing the cuff from fitting properly Radiographic evidence of osteoarthritis (≥ Kellgren-Lawrence Grade 2) History of intra-articular injection into either knee within 3 -months Uncontrolled or untreated inflammatory disorder Acute inflammatory disorder Uncontrolled Diabetes and/or peripheral neuropathy, impaired circulation Uncontrolled cardiac conditions including uncontrolled hypertension Areas of thrombophlebitis, thrombosis Distal wounds or pain below the knee \>4/10 History of or current rhabdomyolysis Prolonged immobilization (\>3 months) Sickle cell anemia Lymphadenectomy Varicose veins, or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis Current infection at or below the level of cuff placement Malignancies in or below the area to be treated Other conditions/medications that would interfere with subject safety or data collection in the opinion of the PI Subjects with an increased risk of non-response as determined by the therapist Once entered in the study, a diagnosis change that affects participation

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Conditions

The condition(s) this trial relates to.

patellofemoral pain syndrome

As listed by the trial registrant

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

Anterior knee pain syndrome Patellofemoral pain syndrome

Contacts and locations

Locations

  • Gaylord Hospital

    Wallingford, Connecticut, 06492, United States

  • Gaylord Specialty Healthcare Outpatient Physical Therapy; Cheshire

    Cheshire, Connecticut, 06410, United States

  • Gaylord Specialty Healthcare Outpatient Physical Therapy; Cromwell

    Cromwell, Connecticut, 06416, United States

  • Gaylord Specialty Healthcare Outpatient Physical Therapy; Madison

    Madison, Connecticut, 06443, United States

  • Gaylord Specialty Healthcare Outpatient Physical Therapy; Wallingford

    Wallingford, Connecticut, 06492, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030, United States

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