TerminatedNot Applicable

Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy

Stopped: Study terminated due to lack of recruitment.

United States1 participantsStarted 2022-11-15

Plain-language summary

The purpose of this study is to determine if Blood Flow Restriction therapy improves patient related outcomes in those diagnosed with Patellofemoral Pain Syndrome compared to those in the sham comparator control group.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Numeric Pain Rating Scale: Enrollment

Timeframe: This assessment will be collected upon enrollment in the study.

Numeric Pain Rating Scale: 1 Week

Timeframe: This assessment will be collected 1-week into treatment

Numeric Pain Rating Scale: 4 Weeks

Timeframe: This assessment will be collected 4-weeks into treatment.

Numeric Pain Rating Scale: 9 Weeks/Discharge

Timeframe: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.

Numeric Pain Rating Scale: 6 Months

Timeframe: This assessment will be collected 6 months post start date.

Numeric Pain Rating Scale: 12 Months

Timeframe: This assessment will be collected 12 months post start date.

Lower Extremity Functional Scale: Enrollment

Timeframe: This assessment will be collected upon enrollment in the study.

Trial details

NCT IDNCT05617911

SponsorGaylord Hospital, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-10

Results submitted2025-11-10

View on ClinicalTrials.gov More Patellofemoral Pain Syndrome trials

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Numeric Pain Rating Scale: Enrollment

Timeframe: This assessment will be collected upon enrollment in the study.

Numeric Pain Rating Scale: 1 Week

Timeframe: This assessment will be collected 1-week into treatment

Numeric Pain Rating Scale: 4 Weeks

Timeframe: This assessment will be collected 4-weeks into treatment.

Numeric Pain Rating Scale: 9 Weeks/Discharge

Timeframe: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.

Numeric Pain Rating Scale: 6 Months

Timeframe: This assessment will be collected 6 months post start date.

Numeric Pain Rating Scale: 12 Months

Timeframe: This assessment will be collected 12 months post start date.

Lower Extremity Functional Scale: Enrollment

Timeframe: This assessment will be collected upon enrollment in the study.