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Clinical Trials/NCT02441712
NCT02441712
Completed
Not Applicable

Supervised Rehabilitation With Patterned Electrical Neuromuscular Stimulation for Patients With Patellofemoral Pain

University of Virginia1 site in 1 country21 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellofemoral Pain Syndrome
Sponsor
University of Virginia
Enrollment
21
Locations
1
Primary Endpoint
Changes in Pain Assessed by Visual Analog Scale (VAS)
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Saliba

Associate Professor

University of Virginia

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

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in Gluteus Medius Muscle Strength(Up to 4 weeks)
  • Changes in Hip Adductor Muscle Strength(Up to 4 weeks)
  • Changes in Lower Extremity Electromyography during a lunge(Up to 4 weeks)
  • Changes in Lower Extremity Electromyography during walking(Up to 4 weeks)
  • Changes in Quadriceps Muscle Strength(Up to 4 weeks)
  • Changes in Hamstring Muscle Strength(Up to 4 weeks)
  • Changes in Lower Extremity Electromyography during a step down task(Up to 4 weeks)
  • Changes in Lower Extremity Electromyography during a single leg squat(Up to 4 weeks)
  • Changes in Patient reported outcomes(Up to 4 weeks)
  • Changes in lower extremity kinematics(Up to 4 weeks)
  • Changes in core strength(Up to 4 weeks)
  • Changes in core activation(Up to 4 weeks)
  • Changes in Lower Extremity Electromyography during jogging(Up to 4 weeks)

Study Sites (1)

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