Trial Outcomes & Findings for Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy (NCT NCT05617911)

Results Overview

The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

This assessment will be collected 4-weeks into treatment.

Results posted on

2025-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Blood Flow Restriction and Standard of Care Therapy The experimental BFR therapy will be incorporated into the standard therapy sessions and will not elongate the treatment session, quantity of sessions or incur any additional cost. As the participant progresses over time in therapy sessions, the discretion of the PT will determine when they have graduated beyond receiving any benefit from BFRT as demonstrated by quad strength. Blood Flow Restriction Cuff: Blood Flow Restriction (BFR) involves the application of an external device to reduce arterial blood flow to the exercising area, while largely occluding venous return from that same area.	Sham and Standard of Care Therapy The sham comparator control group will also follow the Exercise Protocol in their physical therapy sessions with a non inflated blood flow restriction cuff attached in the same position as the experimental group. Similar to the intervention group, as participant's progress in therapy, the Physical Therapist will use their clinical decision making to advance the person through resistance and repetition increases. Sham and standard of Care Therapy: SoC PT + non-inflated BFR cuff
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Blood Flow Restriction and Standard of Care Therapy The experimental BFR therapy will be incorporated into the standard therapy sessions and will not elongate the treatment session, quantity of sessions or incur any additional cost. As the participant progresses over time in therapy sessions, the discretion of the PT will determine when they have graduated beyond receiving any benefit from BFRT as demonstrated by quad strength. Blood Flow Restriction Cuff: Blood Flow Restriction (BFR) involves the application of an external device to reduce arterial blood flow to the exercising area, while largely occluding venous return from that same area.	Sham and Standard of Care Therapy The sham comparator control group will also follow the Exercise Protocol in their physical therapy sessions with a non inflated blood flow restriction cuff attached in the same position as the experimental group. Similar to the intervention group, as participant's progress in therapy, the Physical Therapist will use their clinical decision making to advance the person through resistance and repetition increases. Sham and standard of Care Therapy: SoC PT + non-inflated BFR cuff
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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