MedPath

Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

Not Applicable
Completed
Conditions
Patellofemoral Pain Syndrome
Interventions
Device: PENS
Registration Number
NCT02441712
Lead Sponsor
University of Virginia
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
21
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Motor PENSPENSMotor 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.
Subsensory PENSPENSSubsensory 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
Primary Outcome Measures
NameTimeMethod
Changes in Pain Assessed by Visual Analog Scale (VAS)Pain recorded by the VAS will be collected for 4 weeks

Current and Worse VAS

Secondary Outcome Measures
NameTimeMethod
Changes in Gluteus Medius Muscle StrengthUp to 4 weeks

Muscle strength of the gluteus medius will be measured by individuals performing a maximum contraction against a small device that will measure force output

Changes in Hip Adductor Muscle StrengthUp to 4 weeks

Muscle strength of the hip adductors will be measured by individuals performing a maximum contraction against a small device that will measure force output

Changes in Lower Extremity Electromyography during a lungeUp to 4 weeks

EMG activity of six lower extremity muscles during a lunge

Changes in Lower Extremity Electromyography during walkingUp to 4 weeks

EMG activity of six lower extremity muscles during walking

Changes in Quadriceps Muscle StrengthUp to 4 weeks

Muscle strength of the quadriceps will be measured by individuals performing a maximum contraction against a small device that will measure force output

Changes in Hamstring Muscle StrengthUp to 4 weeks

Muscle strength of the hamstring will be measured by individuals performing a maximum contraction against a small device that will measure force output

Changes in Lower Extremity Electromyography during a step down taskUp to 4 weeks

EMG activity of six lower extremity muscles during a step down task

Changes in Lower Extremity Electromyography during a single leg squatUp to 4 weeks

EMG activity of six lower extremity muscles during a single leg squat

Changes in Patient reported outcomesUp to 4 weeks

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.

Changes in lower extremity kinematicsUp to 4 weeks

Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging

Changes in core strengthUp to 4 weeks

Trunk endurance will be assessed by front and side plank tasks.

Changes in core activationUp to 4 weeks

Core activation will be assessed by real time ultrasound to examine the size of the core muscles

Changes in Lower Extremity Electromyography during joggingUp to 4 weeks

EMG activity of six lower extremity muscles during jogging

Trial Locations

Locations (1)

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

© Copyright 2025. All Rights Reserved by MedPath