Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty

Completed · Not applicable

Conditions studied: Patellofemoral Pain Syndrome

In brief

The overall objective of this project is to compare the three home-managed treatment regimens for PFPS: neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), and NMES combined with TENS to a standard home exercise program (HEP). Each of the three treatment arms will be supplemented by HEP and compared to a group receiving standard HEP alone. The central hypothesis is that the combination of NMES with TENS will show significantly greater improvements in muscle strength, mobility, pain, daily activity and quality of life (QOL) than HEP alone. The investigators are examining: 1) whether the three treatment regimens are significantly more efficacious than standard HEP alone in improving lower extremity muscle strength, physical activity, mobility, pain, and quality of life; 2) lower extremity muscle strength, physical activity, mobility, pain, and quality of life differ significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to lower extremity muscle strength, physical activity, mobility, pain, and quality of life.

Key facts

Study ID

NCT02597673

Run by

University of Tennessee

People needed

132

Starts

2015-07-01

Expected to finish

2018-05-31

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The study will be open to all active duty personal 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;
• age ≥18 and <45 years; and
• ability to provide freely given informed consent.

You may not qualify if…

• Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with
• 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 or pacemaker/defibrillator) in which 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;
• Knee instability or recurrent patella dislocation or subluxation;
• Inability or unwillingness to participate in a home exercise program or strengthening program;
• Inability to speak and/or read English;
• Reduced sensory perception in the lower extremities;
• Pregnancy;
• Vision impairment, where participant is classified as legally blind;
• Unwillingness to accept random assignment; or
• A score of 23 or greater on the Center for Epidemiological Studies-Depression scale (CES-D).

Where it is running

• Blanchfield Army Community Hospital — Fort Campbell North, Kentucky, United States

Full record on ClinicalTrials.gov

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