Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty

NACompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

August 4, 2020

Primary Completion Date

March 31, 2022

Study Completion Date

March 31, 2022

Conditions
Patellofemoral Pain Syndrome
Interventions
DEVICE

NMES and exercise supplemented with high BFR

"The BFR-NMES-Exercise training consists of 20-min sessions performed concurrently with NMES and exercise in the clinic 2x a week for a total of 18 in-clinic sessions. Using the Delfi PTS Personalized Tourniquet System for Blood Flow Restriction at 80% of LOP, the participant performs 4 exercise sets of 60 repetitions (5 seconds ea) for 5 minutes, with a 1-minute BFR deflation between sets. The standard exercise rehabilitation protocol for PFPS combines open chain and closed chain quadriceps strengthening exercises: active straight leg raises, quadriceps straightening, step up, and squats. NMES training consists of 20-minute sessions: a 2-min warm-up, 15-min work-out, and a 3-min cool down using the KneeHAB® XP Multipath stimulation system which changes the current pathways between the electrodes for preset periods within each pulse, allowing for higher stimulation intensities that maximizes muscle fibre recruitment and minimizes muscle fatigue."

DEVICE

NMES and exercise supplemented with low BFR

"The BFR-NMES-Exercise training consists of 20-min sessions performed concurrently with NMES and exercise in the clinic 2x a week for a total of 18 in-clinic sessions. Using the Delfi PTS Personalized Tourniquet System for Blood Flow Restriction at 20mmHG venous pressure (no blood flow restricted), the participant performs 4 exercise sets of 60 repetitions (5 seconds ea) for 5 minutes, with a 1-minute BFR deflation between sets. The standard exercise rehabilitation protocol for PFPS combines open chain and closed chain quadriceps strengthening exercises: active straight leg raises, quadriceps straightening, step up, and squats. NMES training consists of 20-minute sessions: a 2-min warm-up, 15-min work-out, and a 3-min cool down using the KneeHAB® XP Multipath stimulation system which changes the current pathways between the electrodes for preset periods within each pulse, allowing for higher stimulation intensities that maximizes muscle fibre recruitment and minimizes muscle fatigue."

Trial Locations (1)

42223

Blanchfield Army Community Hospital (BACH), Fort Campbell North

All Listed Sponsors
collaborator

Blanchfield Army Community Hospital

FED

lead

University of Tennessee

OTHER

NCT04086615 - Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty | Biotech Hunter | Biotech Hunter