Trial of Neurostimulation and Blood Flow Restriction for PFPS in Active Duty
Completed · Not applicable
Conditions studied: Patellofemoral Pain Syndrome
In brief
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.
Key facts
- Study ID
- NCT04086615
- Run by
- University of Tennessee
- People needed
- 84
- Starts
- 2020-08-04
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2022-06-06
Who can join
Age: 18 and older, up to 44. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Blanchfield Army Community Hospital (BACH) — Fort Campbell North, Kentucky, United States
Full record on ClinicalTrials.gov
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