Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Study Overview
=================
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.

Official Title
-----------------
Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Conditions
-----------------
Patellofemoral Pain Syndrome

Intervention / Treatment
-----------------
* Device: PENS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor PENS<br>Motor PENS will be a strong tri-phasic stimulation pattern to the hip, quadriceps, hamstring, and adductors for strength training (50Hz impulses for 200ms every 1500 ms). The stimulus will be administered for 15-minutes followed by the impairment rehabilitation program. | Device: PENS<br> <br> |
| Sham Comparator: Subsensory PENS<br>Subsensory PENS will be a sub sensory stimulus also administered by a tri-phasic stimulation pattern to the hip, quadriceps, hamstring, and adductors (50Hz impulses for 200ms every 1500ms). The stimulus will be administered for 15-minutes followed by the impairment rehabilitation program | Device: PENS<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Assessed by Visual Analog Scale (VAS) | Current and Worse VAS | Pain recorded by the VAS will be collected for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quadriceps Muscle Strength | Muscle strength of the quadriceps will be measured by individuals performing a maximum contraction against a small device that will measure force output | Up to 4 weeks | 
| Changes in Hamstring Muscle Strength | Muscle strength of the hamstring will be measured by individuals performing a maximum contraction against a small device that will measure force output | Up to 4 weeks | 
| Changes in Gluteus Medius Muscle Strength | Muscle strength of the gluteus medius will be measured by individuals performing a maximum contraction against a small device that will measure force output | Up to 4 weeks | 
| Changes in Hip Adductor Muscle Strength | Muscle strength of the hip adductors will be measured by individuals performing a maximum contraction against a small device that will measure force output | Up to 4 weeks | 
| Changes in Lower Extremity Electromyography during a step down task | EMG activity of six lower extremity muscles during a step down task | Up to 4 weeks | 
| Changes in Lower Extremity Electromyography during a single leg squat | EMG activity of six lower extremity muscles during a single leg squat | Up to 4 weeks | 
| Changes in Lower Extremity Electromyography during a lunge | EMG activity of six lower extremity muscles during a lunge | Up to 4 weeks | 
| Changes in Lower Extremity Electromyography during walking | EMG activity of six lower extremity muscles during walking | Up to 4 weeks | 
| Changes in Lower Extremity Electromyography during jogging | EMG activity of six lower extremity muscles during jogging | Up to 4 weeks | 
| Changes in Patient reported outcomes | 4 patient reported outcomes on pain and function before and after the intervention. These patient reported outcomes are the Anterior Knee Pain Scale, the Activities of Daily Living Scale, the Godin Leisure Scale, and the Fear Avoidance Belief Questionnaire. | Up to 4 weeks | 
| Changes in lower extremity kinematics | Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging | Up to 4 weeks | 
| Changes in core strength | Trunk endurance will be assessed by front and side plank tasks. | Up to 4 weeks | 
| Changes in core activation | Core activation will be assessed by real time ultrasound to examine the size of the core muscles | Up to 4 weeks |