Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 4, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE March 2015
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Changes in Lower Extremity Electromyography during a lunge [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during a lunge
  • Changes in Lower Extremity Electromyography during walking [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during walking
  • Changes in Lower Extremity Electromyography during jogging [ Time Frame: Up to 4 weeks ]
    EMG activity of six lower extremity muscles during jogging
  • 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.
  • 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
  • Changes in core strength [ Time Frame: Up to 4 weeks ]
    Trunk endurance will be assessed by front and side plank tasks.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
Official Title  ICMJE Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE Device: PENS
Study Arms  ICMJE
  • 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.
    Intervention: 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
    Intervention: Device: PENS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
32
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02441712
Other Study ID Numbers  ICMJE 17909
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Saliba, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • Accelerated Care Plus
  • Mid-Atlantic Athletic Trainers' Association
Investigators  ICMJE
Principal Investigator: Susan Saliba, PhD, ATC, PT University of Virginia
PRS Account University of Virginia
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP