Clinical trial NCT02441712: Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Official title: Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Accelerated Care Plus
name: Mid-Atlantic Athletic Trainers' Association
First posted: 2015-05-12
Enrollment: 21
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized Controlled Trial (RCT) regarding the conservative treatment of patellofemoral pain (PFP) with an impairment based rehabilitation program. Those with PFP can have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns, weak core activation and muscle tightness. Several recent RCT trials have looked at treating single impairments, but to date no RCT have address individualized patient impairments during a rehabilitation program. Abnormal muscle firing patterns have also been identified during functional tasks; such as jogging, stair climbing, and performing a single leg squat. Conflicting studies have produced changes to the quadriceps and hip muscle firing patterns with those with PFP. The abnormal activation patterns has been suggested to be why strengthening programs alone do not improve movement patterns during functional tasks for those with PFP. Patterned electrical neuromuscular stimulation (PENS) is a novel form of electrical stimulation that replicates proper firing patterns based off healthy electromyography patterns. The purpose of the study is to investigate the benefits of PENS with a impairment based rehabilitation program for the treatment of PFP. The rationale for this investigation is to assess the benefits of PENS with therapeutic exercise at improving altered firing patterns of the lower extremity muscles during functional tasks.


Eligibility criteria: Inclusion Criteria:

* Insidious onset of symptoms
* Presence of peri- or retro patellar knee pain during at least two of the following functional activities:

Stair ascent or descent, Running, Kneeling, Squatting, Prolonged sitting, Jumping

* Pain for more than 3 months
* Pain \>3/10 on VAS
* 85 or less on the Anterior Knee Pain Scale

Exclusion Criteria:

* Previous knee surgery
* Internal Derangement
* Ligamentous instability
* Other sources of anterior knee pain(patella tendonitis, osgood schlatter, knee plica, etc)
* Neurological Involvement
* Any biomedical device
* Muscular abnormalities
* Currently pregnant
* Hypersensitivity to electrical stimulation
* Active infection over the site of the electrode placement

Primary outcomes:
measure: Changes in Pain Assessed by Visual Analog Scale (VAS)
timeFrame: Pain recorded by the VAS will be collected for 4 weeks
Secondary outcomes:
measure: Changes in Quadriceps Muscle Strength
timeFrame: Up to 4 weeks
measure: Changes in Hamstring Muscle Strength
timeFrame: Up to 4 weeks
measure: Changes in Gluteus Medius Muscle Strength
timeFrame: Up to 4 weeks
measure: Changes in Hip Adductor Muscle Strength
timeFrame: Up to 4 weeks
measure: Changes in Lower Extremity Electromyography during a step down task
timeFrame: Up to 4 weeks
measure: Changes in Lower Extremity Electromyography during a single leg squat
timeFrame: Up to 4 weeks
measure: Changes in Lower Extremity Electromyography during a lunge
timeFrame: Up to 4 weeks
measure: Changes in Lower Extremity Electromyography during walking
timeFrame: Up to 4 weeks
measure: Changes in Lower Extremity Electromyography during jogging
timeFrame: Up to 4 weeks
measure: Changes in Patient reported outcomes
timeFrame: Up to 4 weeks
measure: Changes in lower extremity kinematics
timeFrame: Up to 4 weeks
measure: Changes in core strength
timeFrame: Up to 4 weeks
measure: Changes in core activation
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Susan Saliba, PhD, ATC, PT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Glaviano NR, Marshall AN, Mangum LC, Hart JM, Hertel J, Russell S, Saliba SA. Impairment-Based Rehabilitation With Patterned Electrical Neuromuscular Stimulation and Lower Extremity Function in Individuals With Patellofemoral Pain: A Preliminary Study. J Athl Train. 2019 Mar;54(3):255-269. doi: 10.4085/1062-6050-490-17. Epub 2019 Feb 5.