Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty (BFR)
Patellofemoral Pain Syndrome
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Active duty military personnel who are:
- diagnosed with knee pain, categorized as anterior or retropatellar in one or both knees;
- self-reported difficulty performing at least two or more of the following activities associated with knee pain: prolonged sitting, stair climbing, running, jumping, and repetitive movements such as kneeling or squatting or stooping;
- military service member at the time of diagnosis and length of study;
- age ≥18 and <45 years; and
- able to provide freely given informed consent.
Exclusion Criteria:
- fracture or injury to external knee structures such that knee extension or flexion is impaired;
- a significant co-morbid medical condition (such as severe hypertension, neurological disorder, sickle cell anemia, or pacemaker/defibrillator) in which BFR, NMES strength training, or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
- previous knee surgeries (i.e., tibiofemoral, patellofemoral) excluding knee arthroscopy > 3 years;
- knee instability or recurrent patella dislocation or subluxation;
- inability or unwillingness to participate in an exercise or strengthening program;
- reduced sensory perception in the lower extremities;
- pregnancy;
- Any vascular disorder (varicose veins, Hx of DVT); or
- unwillingness to accept random assignment.
Sites / Locations
- Blanchfield Army Community Hospital (BACH)
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
NMES and exercise supplemented with high BFR
NMES and exercise supplemented with low BFR
All participants receive a standard exercise rehabilitation protocol for PFPS to be performed singularly at home/work, synchronously with NMES and concurrently with NMES/BFR in-clinic. The PFPS exercises teach muscle strengthening exercises and self-management strategies to prevent recurrence. Participants will receive a portable battery-operated device, KneeHAB® XP (Bio-Medical Research, Galway, Ireland) with the thigh garment. NMES training will consist of 20-minute stimulation sessions performed concurrently with the exercise program. For the BFR training, the automatic Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction (Delfi Medical, Vancouver, BC, Canada) with variable contour nylon cuff (11.5 cm × 86 cm, 2.5 mm thick) will be used. The Delfi PTS system automatically adjusts pressure around the set occlusion pressure. The High BFR group will have the pressure set at 80% of limb occlusion pressure.
All participants receive a standard exercise rehabilitation protocol for PFPS to be performed singularly at home/work, synchronously with NMES and concurrently with NMES/BFR in-clinic. The PFPS exercises teach muscle strengthening exercises and self-management strategies to prevent recurrence. Participants will receive a portable battery-operated device, KneeHAB® XP (Bio-Medical Research, Galway, Ireland) with the thigh garment. NMES training will consist of 20-minute stimulation sessions performed concurrently with the exercise program. For the BFR training, the automatic Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction (Delfi Medical, Vancouver, BC, Canada) with variable contour nylon cuff (11.5 cm × 86 cm, 2.5 mm thick) will be used. The Delfi PTS system automatically adjusts pressure around the set occlusion pressure. The Low BFR group will have the pressure set at 20 mmHg.