N/A
N=130
Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty
Patellofemoral Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02597673 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Lower Extremity Muscle Strength- Extension — 41.58; 37.74; 37.14; 40.42 Kg-Force
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home Exercise Program (HEP) (Other); NMES (Device); TENS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Extremity Muscle Strength- Extension |
41.58; 37.74; 37.14; 40.42; 41.41; 42.70 | — |
| PRIMARY Lower Extremity Muscle Strength- Flexion |
21.85; 20.32; 21.33; 21.95; 22.07; 22.49 | — |
| PRIMARY Lower Extremity Strength- 30-Second Chair Stand Test |
11.6; 11.0; 11.0; 11.0; 13.2; 12.3 | — |
| PRIMARY Lower Extremity Strength- Timed Stair Climb Test |
3.7; 4.0; 4.2; 4.1; 3.6; 3.7 | — |
| PRIMARY Lower Extremity Mobility- Forward Step-down Test |
13.2; 11.3; 10.8; 11.2; 15.4; 12.9 | — |
| PRIMARY Lower Extremity Mobility- 6-Minute Walk Test |
24612; 23931; 23999; 23174; 24373; 24919 | — |
| SECONDARY Current Knee Pain |
3.48; 3.42; 4.24; 3.98; 2.99; 2.78 | — |
| SECONDARY Knee Pain Following Performance Testing- 30-Second Chair Stand Test |
2.9; 2.8; 3.9; 3.6; 2.9; 2.2 | — |
| SECONDARY Knee Pain Following Performance Testing- Stair Climb Test |
2.7; 2.7; 3.5; 3.0; 2.6; 2.3 | — |
| SECONDARY Knee Pain Following Performance Testing- Forward Step Down Test |
4.2; 4.2; 5.2; 5.3; 3.8; 3.2 | — |
| SECONDARY Knee Pain Following Performance Testing- 6-Minute Walk Test |
3.2; 2.7; 4.5; 3.6; 3.3; 2.5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02597673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.