Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty (NCT04086615) | Clinical Trial Compass
CompletedNot Applicable
Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty
United States84 participantsStarted 2020-08-04
Plain-language summary
The overall objective of this project is to compare two self-managed treatment regimens for PFPS: (1) NMES-Exercise supplemented with high BFR LOP of 80% and (2) NMES Exercise augmented with a low percentage of BFR LOP at 20 mmHG (BFR-sham). Each of the two treatment arms will perform a fixed exercise protocol singularly and in combination with BFR-NMES, and NMES alone. The specific aims of the study are 1) To determine whether self-managed NMES-Exercise program supplemented with a high BFR of 80% LOP (limb occlusion pressure) is significantly more efficacious than NMES-Exercise with low BFR LOP set at 20 mmHG (sham) in improving muscle strength of the lower extremity, daily physical activity and mobility; and 2) To determine whether NMES-Exercise with high LOP BFR therapy improves QOL and PFPS symptoms significantly more than NMES-Exercise with low LOP BFR.
Who can participate
Age range18 Years – 44 Years
SexALL
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Inclusion criteria
✓. 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;