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Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain (PENS for PFP)

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ClinicalTrials.gov Identifier: NCT02441712
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Accelerated Care Plus
Mid-Atlantic Athletic Trainers' Association
Information provided by (Responsible Party):
Susan Saliba, University of Virginia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Device: PENS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Study Start Date : March 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Motor PENS
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
Sham Comparator: Subsensory PENS
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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Pain Assessed by Visual Analog Scale (VAS) [ Time Frame: Pain recorded by the VAS will be collected for 4 weeks ]
    Current and Worse VAS


Secondary Outcome Measures :
  1. Changes in Quadriceps Muscle Strength [ Time Frame: Up 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

  2. Changes in Hamstring Muscle Strength [ Time Frame: Up 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

  3. Changes in Gluteus Medius Muscle Strength [ Time Frame: Up 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

  4. Changes in Hip Adductor Muscle Strength [ Time Frame: Up 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

  5. Changes in Lower Extremity Electromyography during a step down task [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during a step down task

  6. Changes in Lower Extremity Electromyography during a single leg squat [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during a single leg squat

  7. Changes in Lower Extremity Electromyography during a lunge [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during a lunge

  8. Changes in Lower Extremity Electromyography during walking [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during walking

  9. Changes in Lower Extremity Electromyography during jogging [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during jogging

  10. Changes in Patient reported outcomes [ Time Frame: Up 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.

  11. Changes in lower extremity kinematics [ Time Frame: Up to 4 weeks ]
    Trunk, hip, knee and ankle movement during the single leg squat, stair ambulation, lunges, walking and jogging

  12. Changes in core strength [ Time Frame: Up to 4 weeks ]
    Trunk endurance will be assessed by front and side plank tasks.

  13. Changes in core activation [ Time Frame: Up to 4 weeks ]
    Core activation will be assessed by real time ultrasound to examine the size of the core muscles


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441712


Locations
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United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22902
Sponsors and Collaborators
University of Virginia
Accelerated Care Plus
Mid-Atlantic Athletic Trainers' Association
Investigators
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Principal Investigator: Susan Saliba, PhD, ATC, PT University of Virginia
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susan Saliba, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02441712    
Other Study ID Numbers: 17909
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases